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

NCT02940223 | Terminated Phase 2 Results FDA Drug

• 2 other identifiers: 2016-0348NCI-2016-01932
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and at 57±5 days

Secondary Outcomes (2)

• Edmonton Symptom Assessment System (ESAS) Score

  Baseline and at 57±5 days

• Hospital Anxiety and Depression Score

  Baseline and at 57±5 days

Study Arms (3)

Group I (ethyl icosapentate, physical activity)

EXPERIMENTAL

Patients receive ethyl icosapentate 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 continue to receive ethyl icosapentate, complete resistance exercises, and undergo walking program for 4 weeks.

Drug: Ethyl Icosapentate; Behavioral: Exercise Intervention; Other: Laboratory Biomarker Analysis; Behavioral: Quality-of-Life Assessment; Other: Questionnaire Administration

Group II (placebo, physical activity)

EXPERIMENTAL

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.

Behavioral: Exercise Intervention; Other: Laboratory Biomarker Analysis; Other: Placebo; Behavioral: Quality-of-Life Assessment; Other: Questionnaire Administration

Group III (placebo, stretching exercises)

EXPERIMENTAL

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.

Behavioral: Exercise Intervention; Other: Laboratory Biomarker Analysis; Other: Placebo; Behavioral: Quality-of-Life Assessment; Other: Questionnaire Administration

Interventions

Ethyl Icosapentate DRUG

Given by mouth 2 gm orally daily plus physical activity

Also known as: ICOSAPENT ETHYL

Group I (ethyl icosapentate, physical activity)

Exercise Intervention BEHAVIORAL

Complete resistance exercises and undergo walking program

Group I (ethyl icosapentate, physical activity); Group II (placebo, physical activity)

Laboratory Biomarker Analysis OTHER

Correlative studies

Group I (ethyl icosapentate, physical activity); Group II (placebo, physical activity); Group III (placebo, stretching exercises)

Placebo OTHER

Given PO

Also known as: placebo therapy, PLCB, sham therapy

Group II (placebo, physical activity); Group III (placebo, stretching exercises)

Quality-of-Life Assessment BEHAVIORAL

Ancillary studies

Also known as: Quality of Life Assessment

Group I (ethyl icosapentate, physical activity); Group II (placebo, physical activity); Group III (placebo, stretching exercises)

Questionnaire Administration OTHER

Ancillary studies

Group I (ethyl icosapentate, physical activity); Group II (placebo, physical activity); Group III (placebo, stretching exercises)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of advanced cancer
• Patients should describe fatigue as being present for a minimum of 2 weeks
• Patients should rate the severity of fatigue as 4/10 in a 0-10 ESAS scale, where 0 = no fatigue, 10 = worse fatigue possible
• If patients are on opioids for the treatment of cancer pain, they must have had no major dose change (\> 25%) for at least 48 hours prior to study entry; change in opioid dose after study entry is allowed
• Presence of relatively intact cognition defined by normal memorial delirium assessment scale (\< 7/30); sign written informed consent
• Patient willing to keep a daily diary, engage in telephone follow up with a nurse
• Patient must have telephone access to be contacted by the research nurse
• Hemoglobin of \>= 10 g/dl within 2 weeks of enrollment; if the patient has not had blood drawn for a hemoglobin level in the past two weeks, one will be done to determine the eligibility
• Patients should have a Zubrod =\< 1
• Life expectancy of \>= 4 months
• Subjects must be able to understand and be willing to sign the written informed consent form; a signed informed consent form must be appropriately obtained prior to the conduct of any trial-specific procedure
• Total bilirubin =\< 1.5 x the upper limits of normal (ULN)
• Alanine aminotransferase (ALT) and aspartate amino-transferase (AST) =\< 2.5 x ULN (=\< 5 x ULN for subjects with liver involvement of their cancer)
• Alkaline phosphatase limit =\< 2.5 x ULN (=\< 5 x ULN for subjects with liver involvement of their cancer)
• Serum creatinine =\< 1.5 x the ULN

You may not qualify if:

• Major contraindication to fish oil i.e. hypersensitivity to fish/oil or physical activity
• Currently on fish oil or has been on fish oil within the last 10 days
• Inability to complete the baseline assessment forms or to understand the recommendations for participation in the study
• Pregnant or lactating women; childbearing age women are not on birth control
• Reports a fall in the past 30 days
• Patient reported regular participation in moderate- or vigorous-intensity physical activity for at \>= 30 minutes at least 5 times a week and strength training for \>= 2 days/week
• Signs of third spacing as determined by the treating physician (e.g., pedal edema, pleural effusion, ascites)
• Previous assignment to treatment during this study; subjects permanently withdrawn from study participation will not be allowed to re-enter study
• Uncontrolled hypertension (systolic pressure \>140 mm Hg or diastolic pressure \> 90 mm Hg \[National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.0\] on repeated measurement) despite optimal medical management
• Active or clinically significant cardiac disease including: a. congestive heart failure-New York Heart Association (NYHA) \> class II; b. active coronary artery disease; c. cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin; d. unstable angina (anginal symptoms at rest), new-onset angina within 3 months before randomization, or myocardial infarction within 6 months before randomization
• Evidence or history of bleeding diathesis or coagulopathy
• Any hemorrhage or bleeding event \>= NCI CTCAE grade 3 within 4 weeks prior to start of study medication
• Subjects with thrombotic, embolic, venous, or arterial events, such as cerebrovascular accident (including transient ischemic attacks) deep vein thrombosis or pulmonary embolism within 6 months of start of study treatment within 6 months of informed consent
• Patients with any previously untreated or concurrent cancer that is distinct in primary site or histology except cervical cancer in-situ, treated ductal carcinoma in situ of the breast, curatively treated nonmelanoma skin carcinoma, noninvasive aerodigestive neoplasms, or superficial bladder tumor; subjects surviving a cancer that was curatively treated and without evidence of disease for more than 3 years before registration are allowed; all cancer treatments must be completed at least 3 years prior to registration
• Patients with phaeochromocytoma

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center Website

MeSH Terms

Conditions

Fatigue

Interventions

eicosapentaenoic acid ethanolamide; eicosapentaenoic acid ethyl ester

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Sriram Yennu,Professor, MD- Palliative Care Med
• Organization: UT MD Anderson Cancer Center

syennu@mdanderson.org

(713) 792-3938

Study Officials

• Sriram Yennu

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2016
• First Posted: October 20, 2016
• Study Start: March 16, 2017
• Primary Completion: November 24, 2020
• Study Completion: November 24, 2020
• Last Updated: June 10, 2021
• Results First Posted: June 10, 2021

Record last verified: 2021-05

Locations

US (1)