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

NCT02940223 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2021-06-10

Study results available
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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.

Conditions

  • Advanced Malignant Neoplasm
  • Fatigue

Interventions

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

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Sriram Yennu · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-16
Primary Completion
2020-11-24
Completion
2020-11-24
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02940223 on ClinicalTrials.gov