Trial Outcomes & Findings for Ethyl Icosapentate and Physical Activity in Treating Fatigue in Patients With Advanced Cancer (NCT NCT02940223)
NCT ID: NCT02940223
Last Updated: 2021-06-10
Results Overview
Cancer related fatigue was measured using the 13 questions of Functional Assessment of Chronic Illness Therapy - Fatigue subscale on a four point Likert scale (0=not at all fatigue to 4= very much fatigued). We measured the difference in Functional Assessment of Chronic Illness Therapy - Fatigue subscale score between baseline and 57±5 days, among patients who would receive either Icosapent ethyl plus physical activity and placebo plus physical activity.
TERMINATED
PHASE2
2 participants
Baseline and at 57±5 days
2021-06-10
Participant Flow
Patients with advanced cancers aged \>=18 years with fatigue for 2 weeks were recruited from MD Anderson Cancer Center between 3/16/2017 (check activation date) and 10/2/2017 (check last patient off study date).
A total of 2 participants were recruited before the study was aborted due to low accrual..
Participant milestones
| Measure |
Intervention Group (Icosapent Ethyl)
Received 1 mg Icosapent Ethyl capsules orally twice a daily plus physical activity for 8 weeks
|
Placebo
Received placebo capsules orally twice a day plus physical activity for 8 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Intervention Group (Icosapent Ethyl)
Received 1 mg Icosapent Ethyl capsules orally twice a daily plus physical activity for 8 weeks
|
Placebo
Received placebo capsules orally twice a day plus physical activity for 8 weeks
|
|---|---|---|
|
Overall Study
Failed Requirement
|
2
|
0
|
Baseline Characteristics
Ethyl Icosapentate and Physical Activity in Treating Fatigue in Patients With Advanced Cancer
Baseline characteristics by cohort
| Measure |
Intervention Group (Icosapent Ethyl)
n=2 Participants
Received 1 mg Icosapent Ethyl capsules orally twice a daily plus physical activity for 8 weeks
|
Placebo
Received placebo capsules orally twice a day plus physical activity for 8 weeks
|
Total
n=2 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=99 Participants
|
—
|
2 participants
n=206 Participants
|
|
Cancer Type
Colorectal
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Cancer Type
Hepatic
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline and at 57±5 daysPopulation: Due to low accrual and early termination of the protocol no analysis was done to determine the Cancer related fatigue.
Cancer related fatigue was measured using the 13 questions of Functional Assessment of Chronic Illness Therapy - Fatigue subscale on a four point Likert scale (0=not at all fatigue to 4= very much fatigued). We measured the difference in Functional Assessment of Chronic Illness Therapy - Fatigue subscale score between baseline and 57±5 days, among patients who would receive either Icosapent ethyl plus physical activity and placebo plus physical activity.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and at 57±5 daysPopulation: Due to low accrual and early termination of the protocol no analysis was done to determine the Edmonton Symptom Assessment System score.
Edmonton Symptom Assessment System score was measured using 10 question Edmonton Symptom Assessment System form with 0-10 scale with 0= no symptom and 10=worst symptom imaginable. We measured the difference in Edmonton Symptom Assessment System score between baseline and 57±5 days, among patients who would receive either Icosapent ethyl plus physical activity and placebo plus physical activity.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and at 57±5 daysPopulation: Due to low accrual and early termination of the protocol no analysis was done to determine the Hospital Anxiety and Depression score.
Hospital Anxiety and Depression score was measured using 14 questions HADS form with 0-4 scale with 0= no symptom and 4=worst symptom. We measured the difference in Hospital Anxiety and Depression score between baseline and 57±5 days, among patients who would receive either Icosapent ethyl plus physical activity and placebo plus physical activity.
Outcome measures
Outcome data not reported
Adverse Events
Intervention Group (Icosapent Ethyl)
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Sriram Yennu,Professor, MD- Palliative Care Med
UT MD Anderson Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place