NCT02940223

Ethyl Icosapentate and Physical Activity in Treating Fatigue in Patients With Advanced Cancer

Effects of Fish Oil and Physical Activity on Fatigue in Patients With Advanced Cancer

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This randomized phase II trial studies how well ethyl icosapentate and physical activity work in treating fatigue in patients with cancer that has spread from where it started to other places in the body. Ethyl icosapentate and physical activity may provide more robust and clinically effective improvement of cancer related fatigue, which may facilitate patients continuing cancer therapy since it would be tolerated and effective in controlling disease.

Detailed description

PRIMARY OBJECTIVES: I. To determine the effect of the combination of ethyl icosapentate (icosapent ethyl) 2 gm orally daily plus physical activity (PA) for the reduction of cancer related fatigue (CRF) (Functional Assessment of Chronic Illness Therapy - Fatigue \[FACIT-F\] subscale) at the end of 8 weeks in patients with advanced cancer by comparing the difference between the FACIT-F subscale score at baseline and at 57 +/- 5 days, between patients who will receive either Icosapent ethyl plus physical activity and placebo plus physical activity. SECONDARY OBJECTIVES: I. To determine the feasibility, adherence, and satisfaction of using the combined intervention for the reduction of cancer related fatigue in advanced cancer. II. To explore the effects of the combination of Icosapent ethyl 2 gm orally daily plus physical activity on quality of life (QOL)-related variables, mood (HADS - Hospital Anxiety and Depression Inventory), quality of life domains (Functional Assessment of Cancer Therapy - General \[FACT-G\]), cancer related symptoms (Edmonton Symptom Assessment Scale - ESAS) in these patients. III. To explore the effects of combined intervention on serum C - reactive protein and intracellular cytokine levels (IL-6, TNF-a, IL-10, IL-1RA) before and after treatment. IV. To explore its side effects and tolerability of the combined study interventions in these patients. V. To explore the effect of multimodal therapy on body composition. VI. To explore the effect of the proposed treatment in this study on the overall survival time in patients. OUTLINE: Patients are randomized to 1 of 3 groups. GROUP I: Patients receive ethyl icosapentate orally (PO) twice daily (BID) for 8 weeks. Patients complete resistance exercises 3 days per week and undergo walking program at least 5 days per week for 8 weeks. After 8 weeks, patients may optionally continue to receive ethyl icosapentate, complete resistance exercises, and undergo walking program for 4 weeks. GROUP II: Patients receive placebo PO BID for 8 weeks. Patients complete resistance exercises 3 days per week and undergo walking program at least 5 days per week for 8 weeks. After 8 weeks, patients may optionally receive ethyl icosapentate, complete resistance exercises, and undergo walking program for 4 weeks as in Group I. GROUP III: Patients receive placebo PO BID for 8 weeks. Patients meet with an exercise specialist during the first week to learn different stretching exercises and complete the stretching exercises 3 days per week for 8 weeks. After 8 weeks, patients may optionally receive ethyl icosapentate, complete resistance exercises, and undergo walking program for 4 weeks as in Group I. After completion of study treatment, patients are followed up at 1 month.

Conditions

• Advanced Malignant Neoplasm
• Fatigue

Interventions

Type	Name	Description
DRUG	Ethyl Icosapentate	Given by mouth 2 gm orally daily plus physical activity
BEHAVIORAL	Exercise Intervention	Complete resistance exercises and undergo walking program
BEHAVIORAL	Exercise Intervention	Meet with exercise specialist and complete stretching exercises
OTHER	Laboratory Biomarker Analysis	Correlative studies
OTHER	Placebo	Given PO
BEHAVIORAL	Quality-of-Life Assessment	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2017-03-16
• Primary completion: 2020-11-24
• Completion: 2020-11-24
• First posted: 2016-10-20
• Last updated: 2021-06-10
• Results posted: 2021-06-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study