Trial Outcomes & Findings for Ethyl Icosapentate and Physical Activity in Treating Fatigue in Patients With Advanced Cancer (NCT 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.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

2 participants

Primary outcome timeframe

Baseline and at 57±5 days

Results posted on

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

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

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

PRIMARY outcome

Timeframe: Baseline and at 57±5 days

Population: Due to low accrual and early termination of the protocol no analysis was done to determine the Cancer related fatigue.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and at 57±5 days

Population: 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 days

Population: 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)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

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

Phone: (713) 792-3938

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

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=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants	—	2 participants n=5 Participants
Cancer Type Colorectal	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Cancer Type Hepatic	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants