Trial Outcomes & Findings for Double-blind Randomized Controlled Trial Comparing Suvorexant 20 mg to Placebo for Treatment of Insomnia in Cancer Survivors (NCT NCT06162663)
NCT ID: NCT06162663
Last Updated: 2026-08-12
Results Overview
The ISI is scored on a scale of 0-28 based on responses to 7 questions, with higher values indicating more severe symptoms of sleep disturbance. Five participants completed the study.
TERMINATED
PHASE4
6 participants
4 weeks
2026-08-12
Participant Flow
A total of 5 participants completed the study.
Participant milestones
| Measure |
Suvorexant With Information on Sleep Hygiene
Participants randomized to this arm will receive 10 mg of suvorexant daily with a dose increase to 20 mg after day 7. Medication will be administered as an oral medication. Total duration of 28 days.
|
Placebo With Information on Sleep Hygiene
Participants randomized to this arm will placebo control with a similar mechanism of dispensation as the intervention arm. Medication will be administered as an oral medication. Total duration of 28 days.
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
|
Overall Study
COMPLETED
|
2
|
3
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Suvorexant With Information on Sleep Hygiene
Participants randomized to this arm will receive 10 mg of suvorexant daily with a dose increase to 20 mg after day 7. Medication will be administered as an oral medication. Total duration of 28 days.
|
Placebo With Information on Sleep Hygiene
Participants randomized to this arm will placebo control with a similar mechanism of dispensation as the intervention arm. Medication will be administered as an oral medication. Total duration of 28 days.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
One participant did not complete this measure.
Baseline characteristics by cohort
| Measure |
Suvorexant With Information on Sleep Hygiene
n=2 Participants
Participants randomized to this arm will receive 10 mg of suvorexant daily with a dose increase to 20 mg after day 7. Medication will be administered as an oral medication. Total duration of 28 days.
|
Placebo With Information on Sleep Hygiene
n=3 Participants
Participants randomized to this arm will placebo control with a similar mechanism of dispensation as the intervention arm. Medication will be administered as an oral medication. Total duration of 28 days.
|
Total
n=5 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
74 Years
n=2 Participants
|
65 Years
n=3 Participants
|
68 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=2 Participants
|
3 Participants
n=3 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=2 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=2 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=2 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=2 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=2 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=2 Participants
|
2 Participants
n=3 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=2 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=2 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=2 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=2 Participants
|
3 Participants
n=3 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=2 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=5 Participants
|
|
Participant reported insomnia symptoms evaluated using the Insomnia Severity Index (ISI)
|
22.00 Total score
STANDARD_DEVIATION 2.83 • n=2 Participants
|
23.33 Total score
STANDARD_DEVIATION 4.15 • n=3 Participants
|
22.80 Total score
STANDARD_DEVIATION 3.35 • n=5 Participants
|
|
Vasomotor Symptoms assessed using the Hot Flash Related Daily Interference Scale
|
1.65 Scores on a scale
STANDARD_DEVIATION 2.33 • n=2 Participants
|
3.10 Scores on a scale
STANDARD_DEVIATION 2.40 • n=3 Participants
|
2.38 Scores on a scale
STANDARD_DEVIATION 2.11 • n=5 Participants
|
|
Quality of Life evaluated using the Cancer Problems in Living Scale (CPIL)
|
13.0 Scores on a scale
n=1 Participants • One participant did not complete this measure.
|
13.7 Scores on a scale
STANDARD_DEVIATION 7.6 • n=3 Participants • One participant did not complete this measure.
|
13.5 Scores on a scale
STANDARD_DEVIATION 6.2 • n=4 Participants • One participant did not complete this measure.
|
|
Pain Evaluation evaluated using the Brief Pain Inventory (BPI)
|
0.25 Scores on a scale
STANDARD_DEVIATION 0.35 • n=2 Participants
|
4.42 Scores on a scale
STANDARD_DEVIATION 1.42 • n=3 Participants
|
2.75 Scores on a scale
STANDARD_DEVIATION 2.50 • n=5 Participants
|
PRIMARY outcome
Timeframe: 4 weeksPopulation: The analysis population included all enrolled participants who completed the study (N = 5). All participants were assessed according to the study protocol; however, enrollment did not reach the prespecified accrual threshold required for the planned statistical analyses.
The ISI is scored on a scale of 0-28 based on responses to 7 questions, with higher values indicating more severe symptoms of sleep disturbance. Five participants completed the study.
Outcome measures
| Measure |
Suvorexant With Information on Sleep Hygiene
n=2 Participants
Participants randomized to this arm will receive 10 mg of suvorexant daily with a dose increase to 20 mg after day 7. Medication will be administered as an oral medication. Total duration of 28 days.
Suvorexant Tablets: Suvorexant initially with 10-20 mg for 28 days
|
Placebo With Information on Sleep Hygiene
n=3 Participants
Participants randomized to this arm will receive placebo control daily with a switch to an alternate placebo control vial after 7 days, consistent with intervention arms. Medication will be administered as an oral medication. Total duration of 28 days.
Placebo Control: Matched Placebo Control for 28 days
|
|---|---|---|
|
Participant Reported Insomnia Symptoms Evaluated Using the Insomnia Severity Index (ISI)
|
9.5 ISI score
Standard Deviation 13.4
|
12.0 ISI score
Standard Deviation 8.2
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: The analysis population included all enrolled participants who completed the study (N = 5). All participants were assessed according to the study protocol; however, enrollment did not reach the prespecified accrual threshold required for the planned statistical analyses.
Vasomotor symptoms were assessed using the Hot Flash Related Daily Interference Scale. This validated instrument measures the extent to which hot flashes interfere with daily activities and quality of life. Scores range from 0 to 100, with higher scores indicating greater interference due to vasomotor symptoms. Five participants completed the study. Due to early study termination for insufficient accrual, the planned statistical analyses were not performed.
Outcome measures
| Measure |
Suvorexant With Information on Sleep Hygiene
n=2 Participants
Participants randomized to this arm will receive 10 mg of suvorexant daily with a dose increase to 20 mg after day 7. Medication will be administered as an oral medication. Total duration of 28 days.
Suvorexant Tablets: Suvorexant initially with 10-20 mg for 28 days
|
Placebo With Information on Sleep Hygiene
n=3 Participants
Participants randomized to this arm will receive placebo control daily with a switch to an alternate placebo control vial after 7 days, consistent with intervention arms. Medication will be administered as an oral medication. Total duration of 28 days.
Placebo Control: Matched Placebo Control for 28 days
|
|---|---|---|
|
Vasomotor Symptoms Assessed Using the Hot Flash Related Daily Interference Scale
|
3.6 Scores on a scale
Standard Deviation 3.7
|
2.0 Scores on a scale
Standard Deviation 3.4
|
SECONDARY outcome
Timeframe: 4 WeeksPopulation: The analysis population included all enrolled participants who completed the study (N = 5). All participants were assessed according to the study protocol; however, enrollment did not reach the prespecified accrual threshold required for the planned statistical analyses.
Health-related quality of life was assessed using the Medical Outcomes Study 36-Item Short Form Health Survey (SF-36). We have reported the average domain score for the general health domain. Each domain score ranges from 0 to 100, with higher scores indicating better health-related quality of life. Five participants completed the study. Due to early study termination for insufficient accrual, the planned statistical analyses were not performed.
Outcome measures
| Measure |
Suvorexant With Information on Sleep Hygiene
n=2 Participants
Participants randomized to this arm will receive 10 mg of suvorexant daily with a dose increase to 20 mg after day 7. Medication will be administered as an oral medication. Total duration of 28 days.
Suvorexant Tablets: Suvorexant initially with 10-20 mg for 28 days
|
Placebo With Information on Sleep Hygiene
n=3 Participants
Participants randomized to this arm will receive placebo control daily with a switch to an alternate placebo control vial after 7 days, consistent with intervention arms. Medication will be administered as an oral medication. Total duration of 28 days.
Placebo Control: Matched Placebo Control for 28 days
|
|---|---|---|
|
Quality of Life Evaluated Using the SF-36
|
46.6 General Health Domain Score
Standard Deviation 41.6
|
51.6 General Health Domain Score
Standard Deviation 12.6
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: The analysis population included all enrolled participants who completed the study (N = 5). All participants were assessed according to the study protocol; however, enrollment did not reach the prespecified accrual threshold required for the planned statistical analyses.
Problems related to living with cancer were assessed using the Cancer Problems of Living (CPIL) Scale. The CPIL consists of a multi-item list of cancer-related problems across practical, emotional, and social domains. Participants rate each problem based on perceived severity, with higher ratings indicating greater problem severity. Each item is scored on a scale of 0-2 with the composite score reported. Score range from 0 to 58. Five participants completed the study. Due to early study termination for insufficient accrual, the planned statistical analyses were not performed.
Outcome measures
| Measure |
Suvorexant With Information on Sleep Hygiene
n=2 Participants
Participants randomized to this arm will receive 10 mg of suvorexant daily with a dose increase to 20 mg after day 7. Medication will be administered as an oral medication. Total duration of 28 days.
Suvorexant Tablets: Suvorexant initially with 10-20 mg for 28 days
|
Placebo With Information on Sleep Hygiene
n=3 Participants
Participants randomized to this arm will receive placebo control daily with a switch to an alternate placebo control vial after 7 days, consistent with intervention arms. Medication will be administered as an oral medication. Total duration of 28 days.
Placebo Control: Matched Placebo Control for 28 days
|
|---|---|---|
|
Quality of Life Evaluated Using the Cancer Problems in Living Scale (CPIL)
|
14.5 Scores on a scale
Standard Deviation 2.1
|
10 Scores on a scale
Standard Deviation 7.1
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: The analysis population included all enrolled participants who completed the study (N = 5). All participants were assessed according to the study protocol; however, enrollment did not reach the prespecified accrual threshold required for the planned statistical analyses.
Pain severity was assessed using the Brief Pain Inventory (BPI). The BPI asks participants to rate current pain, average pain, least pain, and worst pain on numeric rating scales ranging from 0 to 10, with higher scores indicating greater pain severity. A total pain severity score can be calculated by averaging these items. Score range is from 0 to 10. Five participants completed the study. Due to early study termination for insufficient accrual, the planned statistical analyses were not performed.
Outcome measures
| Measure |
Suvorexant With Information on Sleep Hygiene
n=2 Participants
Participants randomized to this arm will receive 10 mg of suvorexant daily with a dose increase to 20 mg after day 7. Medication will be administered as an oral medication. Total duration of 28 days.
Suvorexant Tablets: Suvorexant initially with 10-20 mg for 28 days
|
Placebo With Information on Sleep Hygiene
n=3 Participants
Participants randomized to this arm will receive placebo control daily with a switch to an alternate placebo control vial after 7 days, consistent with intervention arms. Medication will be administered as an oral medication. Total duration of 28 days.
Placebo Control: Matched Placebo Control for 28 days
|
|---|---|---|
|
Pain Evaluation Evaluated Using the Brief Pain Inventory (BPI)
|
1.9 Score on a scale
Standard Deviation 2.7
|
2.2 Score on a scale
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: The analysis population included all enrolled participants who completed the study (N = 5). All participants were assessed according to the study protocol; however, enrollment did not reach the prespecified accrual threshold required for the planned statistical analyses. The reported results include the number of participants with self-reported medication adherence. The outcome is reported as the number of participants who were considered adherent.
Medication adherence was assessed using the Simplified Medication Adherence Questionnaire (SMAQ). The SMAQ is a brief, participant-reported questionnaire composed of six multiple-choice questions evaluating medication-taking behavior. Non-adherence is indicated by any positive response suggesting missed doses or by reporting more than two missed doses during the preceding week. The outcome reported was the number of participants who were adherent based on this evaluation. Five participants completed the study. Due to early study termination for insufficient accrual, the planned statistical analyses were not performed.
Outcome measures
| Measure |
Suvorexant With Information on Sleep Hygiene
n=2 Participants
Participants randomized to this arm will receive 10 mg of suvorexant daily with a dose increase to 20 mg after day 7. Medication will be administered as an oral medication. Total duration of 28 days.
Suvorexant Tablets: Suvorexant initially with 10-20 mg for 28 days
|
Placebo With Information on Sleep Hygiene
n=3 Participants
Participants randomized to this arm will receive placebo control daily with a switch to an alternate placebo control vial after 7 days, consistent with intervention arms. Medication will be administered as an oral medication. Total duration of 28 days.
Placebo Control: Matched Placebo Control for 28 days
|
|---|---|---|
|
Number of Participants Reported as Adherent Using the Simplified Medication Adherence Questionnaire (SMAQ)
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 2 weeksVasomotor symptoms were assessed using the Hot Flash Related Daily Interference Scale. This validated instrument measures the extent to which hot flashes interfere with daily activities and quality of life. Scores range from 0 to 100, with higher scores indicating greater interference due to vasomotor symptoms. Five participants completed the study. Due to early study termination for insufficient accrual, the planned statistical analyses were not performed.
Outcome measures
| Measure |
Suvorexant With Information on Sleep Hygiene
n=1 Participants
Participants randomized to this arm will receive 10 mg of suvorexant daily with a dose increase to 20 mg after day 7. Medication will be administered as an oral medication. Total duration of 28 days.
Suvorexant Tablets: Suvorexant initially with 10-20 mg for 28 days
|
Placebo With Information on Sleep Hygiene
n=3 Participants
Participants randomized to this arm will receive placebo control daily with a switch to an alternate placebo control vial after 7 days, consistent with intervention arms. Medication will be administered as an oral medication. Total duration of 28 days.
Placebo Control: Matched Placebo Control for 28 days
|
|---|---|---|
|
Vasomotor Symptoms Assessed Using the Hot Flash Related Daily Interference Scale
|
2.5 Scale Score
Only one participant completed this assessment
|
3 Scale Score
Standard Deviation 2.8
|
SECONDARY outcome
Timeframe: 2 weeksThe Insomnia Severity Index (ISI) score was evaluated at baseline, 2 weeks, and 4 weeks. The ISI is scored on a scale of 0-28 based on responses to 7 questions, with higher values indicating more severe symptoms of sleep disturbance. Five participants completed the study. Due to early study termination for insufficient accrual, the planned statistical analyses were not performed.
Outcome measures
| Measure |
Suvorexant With Information on Sleep Hygiene
n=2 Participants
Participants randomized to this arm will receive 10 mg of suvorexant daily with a dose increase to 20 mg after day 7. Medication will be administered as an oral medication. Total duration of 28 days.
Suvorexant Tablets: Suvorexant initially with 10-20 mg for 28 days
|
Placebo With Information on Sleep Hygiene
n=3 Participants
Participants randomized to this arm will receive placebo control daily with a switch to an alternate placebo control vial after 7 days, consistent with intervention arms. Medication will be administered as an oral medication. Total duration of 28 days.
Placebo Control: Matched Placebo Control for 28 days
|
|---|---|---|
|
Participant Reported Insomnia Symptoms Evaluated Using the Insomnia Severity Index (ISI)
|
14.5 ISI score
Standard Deviation 4.6
|
12.7 ISI score
Standard Deviation 5.5
|
SECONDARY outcome
Timeframe: 2 weeksPain severity was assessed using the Brief Pain Inventory (BPI). The BPI asks participants to rate current pain, average pain, least pain, and worst pain on numeric rating scales ranging from 0 to 10, with higher scores indicating greater pain severity. A total pain severity score can be calculated by averaging these items. Score range is from 0 to 10. Five participants completed the study. Due to early study termination for insufficient accrual, the planned statistical analyses were not performed.
Outcome measures
| Measure |
Suvorexant With Information on Sleep Hygiene
n=2 Participants
Participants randomized to this arm will receive 10 mg of suvorexant daily with a dose increase to 20 mg after day 7. Medication will be administered as an oral medication. Total duration of 28 days.
Suvorexant Tablets: Suvorexant initially with 10-20 mg for 28 days
|
Placebo With Information on Sleep Hygiene
n=3 Participants
Participants randomized to this arm will receive placebo control daily with a switch to an alternate placebo control vial after 7 days, consistent with intervention arms. Medication will be administered as an oral medication. Total duration of 28 days.
Placebo Control: Matched Placebo Control for 28 days
|
|---|---|---|
|
Pain Evaluation Evaluated Using the Brief Pain Inventory (BPI)
|
0.6 Scores on a scale
Standard Deviation 0.9
|
5.1 Scores on a scale
Standard Deviation 2.1
|
Adverse Events
Suvorexant With Information on Sleep Hygiene
Placebo With Information on Sleep Hygiene
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Sarah Tucker Marrison
Medical University of South Carolina
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place