Trial Outcomes & Findings for Cognitive Behavioral Therapy and Multimodal Therapy in Treating Sleep Disturbance in Patients With Cancer (NCT NCT01628029)
NCT ID: NCT01628029
Last Updated: 2026-05-22
Results Overview
PSQI consists of 19 items, and it measures several different aspects of sleep, offering seven component scores and one composite score. The component scores consist of subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. Each component score ranges from 0 (no difficulty/good) to 3 (severe difficulty/poor). The global PSQI score is then calculated by totaling (summed) seven component scores, providing an overall score ranging from 0 to 21, where 0 indicates very good sleep quality and 21 signifies very poor sleep quality. A global score of greater than 5 often suggests significant sleep problems. In this study, Wilcoxon signed-rank test was used to determine the p value.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
68 participants
Primary outcome timeframe
Baseline and Day 15
Results posted on
2026-05-22
Participant Flow
Participant milestones
| Measure |
Dim Red Light + Placebo + Placebo
50 lux once a day (30 minutes) for 14 days + Melatonin Placebo + Methylphenidate Placebo
|
Bright White Light Therpay + Melatonin + Placebo
1350 lux once a day (30 minutes) for 14 days + Melatonin 20mg tablet orally at bedtime for 14 days + Methylphenidate Placebo
|
Dim Red Light + Melatonin + Methylphenidate
50 lux once a day (30 minutes) for 14 days + Melatonin 20mg tablet orally at bedtime for 14 days + Methylphenidate 5mg tablet orally twice daily for 14 days
|
Bright White Light Therapy + Placebo + Methylphenidate
1350 lux once a day (30 minutes) for 14 days + Melatonin Placebo + Methylphenidate 5mg tablet orally twice daily for 14 days
|
Bright White Light Therapy + Placebo + Placebo
1350 lux once a day (30 minutes) for 14 days + Melatonin Placebo + Methylphenidate Placebo
|
Dim Red Light + Melatonin + Placebo
50 lux once a day (30 minutes) for 14 days + Melatonin 20mg tablet orally at bedtime for 14 days + Methylphenidate Placebo
|
Dim Red Light + Placebo + Methylphenidate
50 lux once a day (30 minutes) for 14 days + Melatonin Placebo + Methylphenidate 5mg tablet orally twice daily for 14 days
|
Bright White Light Therapy + Melatonin + Methylphenidate
1350 lux once a day (30 minutes) for 14 days + Melatonin 20mg tablet orally at bedtime for 14 days + Methylphenidate 5mg tablet orally twice daily for 14 days
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
9
|
8
|
8
|
9
|
9
|
8
|
7
|
9
|
|
Overall Study
COMPLETED
|
8
|
6
|
5
|
8
|
8
|
7
|
5
|
7
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
3
|
1
|
1
|
1
|
2
|
2
|
Reasons for withdrawal
| Measure |
Dim Red Light + Placebo + Placebo
50 lux once a day (30 minutes) for 14 days + Melatonin Placebo + Methylphenidate Placebo
|
Bright White Light Therpay + Melatonin + Placebo
1350 lux once a day (30 minutes) for 14 days + Melatonin 20mg tablet orally at bedtime for 14 days + Methylphenidate Placebo
|
Dim Red Light + Melatonin + Methylphenidate
50 lux once a day (30 minutes) for 14 days + Melatonin 20mg tablet orally at bedtime for 14 days + Methylphenidate 5mg tablet orally twice daily for 14 days
|
Bright White Light Therapy + Placebo + Methylphenidate
1350 lux once a day (30 minutes) for 14 days + Melatonin Placebo + Methylphenidate 5mg tablet orally twice daily for 14 days
|
Bright White Light Therapy + Placebo + Placebo
1350 lux once a day (30 minutes) for 14 days + Melatonin Placebo + Methylphenidate Placebo
|
Dim Red Light + Melatonin + Placebo
50 lux once a day (30 minutes) for 14 days + Melatonin 20mg tablet orally at bedtime for 14 days + Methylphenidate Placebo
|
Dim Red Light + Placebo + Methylphenidate
50 lux once a day (30 minutes) for 14 days + Melatonin Placebo + Methylphenidate 5mg tablet orally twice daily for 14 days
|
Bright White Light Therapy + Melatonin + Methylphenidate
1350 lux once a day (30 minutes) for 14 days + Melatonin 20mg tablet orally at bedtime for 14 days + Methylphenidate 5mg tablet orally twice daily for 14 days
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Symptom burden
|
1
|
0
|
1
|
0
|
1
|
1
|
2
|
2
|
|
Overall Study
Withdrew due to lack of benefit
|
0
|
1
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Non compliant
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
started different cancer treatment clinical trial
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Incomplete primary outcome assessment
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Cognitive Behavioral Therapy and Multimodal Therapy in Treating Sleep Disturbance in Patients With Cancer
Baseline characteristics by cohort
| Measure |
Dim Red Light + Placebo + Placebo
n=9 Participants
50 lux once a day (30 minutes) for 14 days + Melatonin Placebo + Methylphenidate Placebo
|
Bright White Light Therpay + Melatonin + Placebo
n=6 Participants
1350 lux once a day (30 minutes) for 14 days + Melatonin 20mg tablet orally at bedtime for 14 days + Methylphenidate Placebo
|
Dim Red Light + Melatonin + Methylphenidate
n=7 Participants
50 lux once a day (30 minutes) for 14 days + Melatonin 20mg tablet orally at bedtime for 14 days + Methylphenidate 5mg tablet orally twice daily for 14 days
|
Bright White Light Therapy + Placebo + Methylphenidate
n=9 Participants
1350 lux once a day (30 minutes) for 14 days + Melatonin Placebo + Methylphenidate 5mg tablet orally twice daily for 14 days
|
Bright White Light Therapy + Placebo + Placebo
n=9 Participants
1350 lux once a day (30 minutes) for 14 days + Melatonin Placebo + Methylphenidate Placebo
|
Dim Red Light + Melatonin + Placebo
n=8 Participants
50 lux once a day (30 minutes) for 14 days + Melatonin 20mg tablet orally at bedtime for 14 days + Methylphenidate Placebo
|
Dim Red Light + Placebo + Methylphenidate
n=7 Participants
50 lux once a day (30 minutes) for 14 days + Melatonin Placebo + Methylphenidate 5mg tablet orally twice daily for 14 days
|
Bright White Light Therapy + Melatonin + Methylphenidate
n=9 Participants
1350 lux once a day (30 minutes) for 14 days + Melatonin 20mg tablet orally at bedtime for 14 days + Methylphenidate 5mg tablet orally twice daily for 14 days
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
54 years
n=2 Participants
|
54 years
n=4 Participants
|
50 years
n=6 Participants
|
54 years
n=8 Participants
|
57 years
n=8 Participants
|
55 years
n=28 Participants
|
43 years
|
55 years
n=71 Participants
|
52.5 years
n=40 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=2 Participants
|
6 Participants
n=4 Participants
|
3 Participants
n=6 Participants
|
6 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
4 Participants
n=28 Participants
|
4 Participants
|
4 Participants
n=71 Participants
|
42 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=6 Participants
|
3 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
4 Participants
n=28 Participants
|
3 Participants
|
5 Participants
n=71 Participants
|
22 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=2 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
3 Participants
n=28 Participants
|
0 Participants
|
1 Participants
n=71 Participants
|
10 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=2 Participants
|
4 Participants
n=4 Participants
|
6 Participants
n=6 Participants
|
8 Participants
n=8 Participants
|
8 Participants
n=8 Participants
|
5 Participants
n=28 Participants
|
7 Participants
|
8 Participants
n=71 Participants
|
54 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=28 Participants
|
0 Participants
|
0 Participants
n=71 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=28 Participants
|
0 Participants
|
0 Participants
n=71 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=28 Participants
|
0 Participants
|
0 Participants
n=71 Participants
|
4 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=28 Participants
|
0 Participants
|
0 Participants
n=71 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=28 Participants
|
2 Participants
|
2 Participants
n=71 Participants
|
10 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=2 Participants
|
6 Participants
n=4 Participants
|
5 Participants
n=6 Participants
|
7 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
6 Participants
n=28 Participants
|
5 Participants
|
7 Participants
n=71 Participants
|
50 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=28 Participants
|
0 Participants
|
0 Participants
n=71 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=28 Participants
|
0 Participants
|
0 Participants
n=71 Participants
|
0 Participants
n=40 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=2 Participants
|
6 participants
n=4 Participants
|
7 participants
n=6 Participants
|
9 participants
n=8 Participants
|
9 participants
n=8 Participants
|
8 participants
n=28 Participants
|
7 participants
|
9 participants
n=71 Participants
|
64 participants
n=40 Participants
|
|
Cancer Distribution of the participants
GI
|
2 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=6 Participants
|
2 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
2 Participants
n=28 Participants
|
4 Participants
|
1 Participants
n=71 Participants
|
16 Participants
n=40 Participants
|
|
Cancer Distribution of the participants
GU
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=28 Participants
|
1 Participants
|
2 Participants
n=71 Participants
|
6 Participants
n=40 Participants
|
|
Cancer Distribution of the participants
Breast
|
4 Participants
n=2 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=6 Participants
|
5 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=28 Participants
|
1 Participants
|
2 Participants
n=71 Participants
|
19 Participants
n=40 Participants
|
|
Cancer Distribution of the participants
GYN
|
2 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
1 Participants
n=28 Participants
|
0 Participants
|
1 Participants
n=71 Participants
|
8 Participants
n=40 Participants
|
|
Cancer Distribution of the participants
Lung
|
0 Participants
n=2 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=28 Participants
|
0 Participants
|
1 Participants
n=71 Participants
|
6 Participants
n=40 Participants
|
|
Cancer Distribution of the participants
Sarcoma
|
0 Participants
n=2 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=28 Participants
|
1 Participants
|
1 Participants
n=71 Participants
|
5 Participants
n=40 Participants
|
|
Cancer Distribution of the participants
Other
|
1 Participants
n=2 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=28 Participants
|
0 Participants
|
1 Participants
n=71 Participants
|
4 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: Baseline and Day 15Population: Those who completed the study assessment and treatment
PSQI consists of 19 items, and it measures several different aspects of sleep, offering seven component scores and one composite score. The component scores consist of subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. Each component score ranges from 0 (no difficulty/good) to 3 (severe difficulty/poor). The global PSQI score is then calculated by totaling (summed) seven component scores, providing an overall score ranging from 0 to 21, where 0 indicates very good sleep quality and 21 signifies very poor sleep quality. A global score of greater than 5 often suggests significant sleep problems. In this study, Wilcoxon signed-rank test was used to determine the p value.
Outcome measures
| Measure |
Bright White Light Therapy + Placebo + Methylphenidate
n=8 Participants
1350 lux once a day (30 minutes) for 14 days + Melatonin Placebo + Methylphenidate 5mg tablet orally twice daily for 14 days
|
Bright White Light Therapy + Placebo + Placebo
n=8 Participants
1350 lux once a day (30 minutes) for 14 days + Melatonin Placebo + Methylphenidate Placebo
|
Dim Red Light + Melatonin + Placebo
n=7 Participants
50 lux once a day (30 minutes) for 14 days + Melatonin 20mg tablet orally at bedtime for 14 days + Methylphenidate Placebo
|
Dim Red Light + Placebo + Methylphenidate
n=5 Participants
50 lux once a day (30 minutes) for 14 days + Melatonin Placebo + Methylphenidate 5mg tablet orally twice daily for 14 days
|
Bright White Light Therapy + Melatonin + Methylphenidate
n=7 Participants
1350 lux once a day (30 minutes) for 14 days + Melatonin 20mg tablet orally at bedtime for 14 days + Methylphenidate 5mg tablet orally twice daily for 14 days
|
Dim Red Light + Placebo + Placebo
n=8 Participants
50 lux once a day (30 minutes) for 14 days + Melatonin Placebo + Methylphenidate Placebo
|
Bright White Light Therpay + Melatonin + Placebo
n=6 Participants
1350 lux once a day (30 minutes) for 14 days + Melatonin 20mg tablet orally at bedtime for 14 days + Methylphenidate Placebo
|
Dim Red Light + Melatonin + Methylphenidate
n=5 Participants
50 lux once a day (30 minutes) for 14 days + Melatonin 20mg tablet orally at bedtime for 14 days + Methylphenidate 5mg tablet orally twice daily for 14 days
|
|---|---|---|---|---|---|---|---|---|
|
Pittsburgh Sleep Quality Index (PSQI) Score Change
|
-3.0 score on a scale
Interval -6.0 to 1.5
|
-3.0 score on a scale
Interval -8.0 to -1.0
|
-2.0 score on a scale
Interval -5.0 to 2.0
|
-3.0 score on a scale
Interval -3.0 to -2.0
|
-5.0 score on a scale
Interval -7.0 to -2.0
|
-1.5 score on a scale
Interval -5.0 to 0.0
|
-6.5 score on a scale
Interval -8.0 to -4.0
|
-1.0 score on a scale
Interval -5.0 to 0.0
|
SECONDARY outcome
Timeframe: Baseline and Day 15Population: Those who completed the study assessment and treatment
There are 13 items in this FACIT-F subscale. In this subscale, the patient rates the intensity of fatigue and its related symptoms on a scale from 0 to 4 in the past week. The total score can range between 0 and 52, with higher scores denoting less fatigue. Wilcoxon signed-rank test was used to determine the p-value.
Outcome measures
| Measure |
Bright White Light Therapy + Placebo + Methylphenidate
n=8 Participants
1350 lux once a day (30 minutes) for 14 days + Melatonin Placebo + Methylphenidate 5mg tablet orally twice daily for 14 days
|
Bright White Light Therapy + Placebo + Placebo
n=8 Participants
1350 lux once a day (30 minutes) for 14 days + Melatonin Placebo + Methylphenidate Placebo
|
Dim Red Light + Melatonin + Placebo
n=7 Participants
50 lux once a day (30 minutes) for 14 days + Melatonin 20mg tablet orally at bedtime for 14 days + Methylphenidate Placebo
|
Dim Red Light + Placebo + Methylphenidate
n=5 Participants
50 lux once a day (30 minutes) for 14 days + Melatonin Placebo + Methylphenidate 5mg tablet orally twice daily for 14 days
|
Bright White Light Therapy + Melatonin + Methylphenidate
n=7 Participants
1350 lux once a day (30 minutes) for 14 days + Melatonin 20mg tablet orally at bedtime for 14 days + Methylphenidate 5mg tablet orally twice daily for 14 days
|
Dim Red Light + Placebo + Placebo
n=8 Participants
50 lux once a day (30 minutes) for 14 days + Melatonin Placebo + Methylphenidate Placebo
|
Bright White Light Therpay + Melatonin + Placebo
n=6 Participants
1350 lux once a day (30 minutes) for 14 days + Melatonin 20mg tablet orally at bedtime for 14 days + Methylphenidate Placebo
|
Dim Red Light + Melatonin + Methylphenidate
n=5 Participants
50 lux once a day (30 minutes) for 14 days + Melatonin 20mg tablet orally at bedtime for 14 days + Methylphenidate 5mg tablet orally twice daily for 14 days
|
|---|---|---|---|---|---|---|---|---|
|
Functional Assessment of Chronic Illness Therapy- Fatigue (FACIT-F) Subscale Score Change
|
7.0 score on a scale
Interval 5.0 to 10.5
|
1.0 score on a scale
Interval -8.5 to 13.0
|
13.0 score on a scale
Interval -4.0 to 14.0
|
11.0 score on a scale
Interval 11.0 to 13.0
|
8.0 score on a scale
Interval 5.0 to 22.0
|
7.0 score on a scale
Interval 1.5 to 15.0
|
2.5 score on a scale
Interval -5.0 to 16.0
|
5.0 score on a scale
Interval -2.0 to 17.0
|
SECONDARY outcome
Timeframe: Baseline and Day 15Population: Those who completed the study assessment and treatment
The ISI is a 7-item questionnaire designed to evaluate insomnia severity. Each item is rated using a 5-point Likert scale ranging from 0 (not at all) to 4 (very much), for a total score ranging from 0 to 28 with a cut-off score of 10 or greater indicating significant insomnia. Wilcoxon signed-rank test was used to determine the p-value.
Outcome measures
| Measure |
Bright White Light Therapy + Placebo + Methylphenidate
n=8 Participants
1350 lux once a day (30 minutes) for 14 days + Melatonin Placebo + Methylphenidate 5mg tablet orally twice daily for 14 days
|
Bright White Light Therapy + Placebo + Placebo
n=8 Participants
1350 lux once a day (30 minutes) for 14 days + Melatonin Placebo + Methylphenidate Placebo
|
Dim Red Light + Melatonin + Placebo
n=7 Participants
50 lux once a day (30 minutes) for 14 days + Melatonin 20mg tablet orally at bedtime for 14 days + Methylphenidate Placebo
|
Dim Red Light + Placebo + Methylphenidate
n=5 Participants
50 lux once a day (30 minutes) for 14 days + Melatonin Placebo + Methylphenidate 5mg tablet orally twice daily for 14 days
|
Bright White Light Therapy + Melatonin + Methylphenidate
n=7 Participants
1350 lux once a day (30 minutes) for 14 days + Melatonin 20mg tablet orally at bedtime for 14 days + Methylphenidate 5mg tablet orally twice daily for 14 days
|
Dim Red Light + Placebo + Placebo
n=8 Participants
50 lux once a day (30 minutes) for 14 days + Melatonin Placebo + Methylphenidate Placebo
|
Bright White Light Therpay + Melatonin + Placebo
n=6 Participants
1350 lux once a day (30 minutes) for 14 days + Melatonin 20mg tablet orally at bedtime for 14 days + Methylphenidate Placebo
|
Dim Red Light + Melatonin + Methylphenidate
n=5 Participants
50 lux once a day (30 minutes) for 14 days + Melatonin 20mg tablet orally at bedtime for 14 days + Methylphenidate 5mg tablet orally twice daily for 14 days
|
|---|---|---|---|---|---|---|---|---|
|
Insomnia Severity Index (ISI)) Score Change
|
-4.0 score on a scale
Interval -9.0 to -2.5
|
-9.0 score on a scale
Interval -13.0 to -6.0
|
-4.0 score on a scale
Interval -6.0 to 1.0
|
-13.0 score on a scale
Interval -14.0 to -1.0
|
-7.5 score on a scale
Interval -13.0 to -4.0
|
-6.5 score on a scale
Interval -9.5 to -2.5
|
-11.0 score on a scale
Interval -13.0 to -3.0
|
-10.0 score on a scale
Interval -12.0 to -7.0
|
SECONDARY outcome
Timeframe: Baseline and Day 15Population: Those who completed the study assessment and treatment
The FACT-G is a quality-of-life instrument that is commonly used in cancer clinical trials. FACT-G consists of 27 general quality-of-life questions divided into 4 domains (physical, social, emotional and functional). The patient rates the intensity of symptoms on a Likert scale from 0 (not at all) to 4 (very much). Total score ranges from 0-108 with higher score indicates better Quality of Life. Wilcoxon signed-rank test was used to determine the p-value.
Outcome measures
| Measure |
Bright White Light Therapy + Placebo + Methylphenidate
n=8 Participants
1350 lux once a day (30 minutes) for 14 days + Melatonin Placebo + Methylphenidate 5mg tablet orally twice daily for 14 days
|
Bright White Light Therapy + Placebo + Placebo
n=8 Participants
1350 lux once a day (30 minutes) for 14 days + Melatonin Placebo + Methylphenidate Placebo
|
Dim Red Light + Melatonin + Placebo
n=7 Participants
50 lux once a day (30 minutes) for 14 days + Melatonin 20mg tablet orally at bedtime for 14 days + Methylphenidate Placebo
|
Dim Red Light + Placebo + Methylphenidate
n=5 Participants
50 lux once a day (30 minutes) for 14 days + Melatonin Placebo + Methylphenidate 5mg tablet orally twice daily for 14 days
|
Bright White Light Therapy + Melatonin + Methylphenidate
n=7 Participants
1350 lux once a day (30 minutes) for 14 days + Melatonin 20mg tablet orally at bedtime for 14 days + Methylphenidate 5mg tablet orally twice daily for 14 days
|
Dim Red Light + Placebo + Placebo
n=8 Participants
50 lux once a day (30 minutes) for 14 days + Melatonin Placebo + Methylphenidate Placebo
|
Bright White Light Therpay + Melatonin + Placebo
n=6 Participants
1350 lux once a day (30 minutes) for 14 days + Melatonin 20mg tablet orally at bedtime for 14 days + Methylphenidate Placebo
|
Dim Red Light + Melatonin + Methylphenidate
n=5 Participants
50 lux once a day (30 minutes) for 14 days + Melatonin 20mg tablet orally at bedtime for 14 days + Methylphenidate 5mg tablet orally twice daily for 14 days
|
|---|---|---|---|---|---|---|---|---|
|
Functional Assessment of Cancer Therapy - General (FACT-G) Score Change
|
11.0 score on a scale
Interval -5.0 to 11.0
|
12.0 score on a scale
Interval 1.0 to 19.0
|
5.0 score on a scale
Interval 1.0 to 17.0
|
10.0 score on a scale
Interval 7.0 to 25.0
|
3.0 score on a scale
Interval -1.0 to 11.0
|
4.5 score on a scale
Interval 0.0 to 10.0
|
10.5 score on a scale
Interval 5.0 to 13.0
|
7.0 score on a scale
Interval 6.0 to 19.0
|
Adverse Events
Dim Red Light + Placebo + Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 1 deaths
Bright White Light Therpay + Melatonin + Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Dim Red Light + Melatonin + Methylphenidate
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Bright White Light Therapy + Placebo + Methylphenidate
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Bright White Light Therapy + Placebo + Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Dim Red Light + Melatonin + Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Dim Red Light + Placebo + Methylphenidate
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Bright White Light Therapy + Melatonin + Methylphenidate
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Dim Red Light + Placebo + Placebo
n=9 participants at risk
50 lux once a day (30 minutes) for 14 days + Melatonin Placebo + Methylphenidate Placebo
|
Bright White Light Therpay + Melatonin + Placebo
n=6 participants at risk
1350 lux once a day (30 minutes) for 14 days + Melatonin 20mg tablet orally at bedtime for 14 days + Methylphenidate Placebo
|
Dim Red Light + Melatonin + Methylphenidate
n=7 participants at risk
50 lux once a day (30 minutes) for 14 days + Melatonin 20mg tablet orally at bedtime for 14 days + Methylphenidate 5mg tablet orally twice daily for 14 days
|
Bright White Light Therapy + Placebo + Methylphenidate
n=9 participants at risk
1350 lux once a day (30 minutes) for 14 days + Melatonin Placebo + Methylphenidate 5mg tablet orally twice daily for 14 days
|
Bright White Light Therapy + Placebo + Placebo
n=9 participants at risk
1350 lux once a day (30 minutes) for 14 days + Melatonin Placebo + Methylphenidate Placebo
|
Dim Red Light + Melatonin + Placebo
n=8 participants at risk
50 lux once a day (30 minutes) for 14 days + Melatonin 20mg tablet orally at bedtime for 14 days + Methylphenidate Placebo
|
Dim Red Light + Placebo + Methylphenidate
n=7 participants at risk
50 lux once a day (30 minutes) for 14 days + Melatonin Placebo + Methylphenidate 5mg tablet orally twice daily for 14 days
|
Bright White Light Therapy + Melatonin + Methylphenidate
n=9 participants at risk
1350 lux once a day (30 minutes) for 14 days + Melatonin 20mg tablet orally at bedtime for 14 days + Methylphenidate 5mg tablet orally twice daily for 14 days
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/9 • Baseline to Day 15
|
0.00%
0/6 • Baseline to Day 15
|
0.00%
0/7 • Baseline to Day 15
|
0.00%
0/9 • Baseline to Day 15
|
0.00%
0/9 • Baseline to Day 15
|
0.00%
0/8 • Baseline to Day 15
|
14.3%
1/7 • Baseline to Day 15
|
0.00%
0/9 • Baseline to Day 15
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/9 • Baseline to Day 15
|
0.00%
0/6 • Baseline to Day 15
|
14.3%
1/7 • Baseline to Day 15
|
0.00%
0/9 • Baseline to Day 15
|
0.00%
0/9 • Baseline to Day 15
|
0.00%
0/8 • Baseline to Day 15
|
0.00%
0/7 • Baseline to Day 15
|
0.00%
0/9 • Baseline to Day 15
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/9 • Baseline to Day 15
|
0.00%
0/6 • Baseline to Day 15
|
0.00%
0/7 • Baseline to Day 15
|
11.1%
1/9 • Baseline to Day 15
|
0.00%
0/9 • Baseline to Day 15
|
0.00%
0/8 • Baseline to Day 15
|
14.3%
1/7 • Baseline to Day 15
|
0.00%
0/9 • Baseline to Day 15
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/9 • Baseline to Day 15
|
0.00%
0/6 • Baseline to Day 15
|
0.00%
0/7 • Baseline to Day 15
|
11.1%
1/9 • Baseline to Day 15
|
0.00%
0/9 • Baseline to Day 15
|
0.00%
0/8 • Baseline to Day 15
|
0.00%
0/7 • Baseline to Day 15
|
0.00%
0/9 • Baseline to Day 15
|
|
General disorders
Death (NOS)
|
11.1%
1/9 • Baseline to Day 15
|
0.00%
0/6 • Baseline to Day 15
|
0.00%
0/7 • Baseline to Day 15
|
0.00%
0/9 • Baseline to Day 15
|
0.00%
0/9 • Baseline to Day 15
|
0.00%
0/8 • Baseline to Day 15
|
0.00%
0/7 • Baseline to Day 15
|
0.00%
0/9 • Baseline to Day 15
|
|
Gastrointestinal disorders
Diarrhea
|
11.1%
1/9 • Baseline to Day 15
|
0.00%
0/6 • Baseline to Day 15
|
0.00%
0/7 • Baseline to Day 15
|
0.00%
0/9 • Baseline to Day 15
|
0.00%
0/9 • Baseline to Day 15
|
0.00%
0/8 • Baseline to Day 15
|
0.00%
0/7 • Baseline to Day 15
|
0.00%
0/9 • Baseline to Day 15
|
|
Gastrointestinal disorders
Dysphagia
|
22.2%
2/9 • Baseline to Day 15
|
0.00%
0/6 • Baseline to Day 15
|
0.00%
0/7 • Baseline to Day 15
|
0.00%
0/9 • Baseline to Day 15
|
0.00%
0/9 • Baseline to Day 15
|
12.5%
1/8 • Baseline to Day 15
|
0.00%
0/7 • Baseline to Day 15
|
0.00%
0/9 • Baseline to Day 15
|
|
Blood and lymphatic system disorders
Oedema limbs
|
0.00%
0/9 • Baseline to Day 15
|
0.00%
0/6 • Baseline to Day 15
|
0.00%
0/7 • Baseline to Day 15
|
0.00%
0/9 • Baseline to Day 15
|
0.00%
0/9 • Baseline to Day 15
|
12.5%
1/8 • Baseline to Day 15
|
0.00%
0/7 • Baseline to Day 15
|
0.00%
0/9 • Baseline to Day 15
|
|
Gastrointestinal disorders
Hepatic Infection
|
0.00%
0/9 • Baseline to Day 15
|
0.00%
0/6 • Baseline to Day 15
|
0.00%
0/7 • Baseline to Day 15
|
0.00%
0/9 • Baseline to Day 15
|
11.1%
1/9 • Baseline to Day 15
|
0.00%
0/8 • Baseline to Day 15
|
0.00%
0/7 • Baseline to Day 15
|
0.00%
0/9 • Baseline to Day 15
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.00%
0/9 • Baseline to Day 15
|
0.00%
0/6 • Baseline to Day 15
|
0.00%
0/7 • Baseline to Day 15
|
0.00%
0/9 • Baseline to Day 15
|
0.00%
0/9 • Baseline to Day 15
|
0.00%
0/8 • Baseline to Day 15
|
14.3%
1/7 • Baseline to Day 15
|
0.00%
0/9 • Baseline to Day 15
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place