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Advanced Malignant NeoplasmPhase 2NCT02940223

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

A Phase 2 study testing Ethyl Icosapentate, Exercise Intervention and Laboratory Biomarker Analysis in people with Advanced Malignant Neoplasm and Fatigue, run by M.D. Anderson Cancer Center at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Malignant Neoplasm, Fatigue
What is being tested?
Ethyl Icosapentate, Exercise Intervention and Laboratory Biomarker Analysis
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
2 participants
Where
1 siteUnited States
Study dates
16 Mar 2017to 24 Nov 2020
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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
  • International normalized ratio (INR)/ partial thromboplastin time (PTT) =< 1.5 x ULN
  • Platelet count > 100000/mm^3
  • Hemoglobin (Hb) > 9 g/dL
  • Absolute neutrophil count (ANC) 1500/mm^3
  • Blood transfusion to meet the inclusion criteria will not be allowed
  • Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of study drug; post-menopausal women (defined as no menses for at least 1 year) and surgically sterilized women are not required to undergo a pregnancy test; the definition of adequate contraception will be based on the judgment of the investigator
  • Subjects (men and women) of childbearing potential must agree to use adequate contraception beginning at the signing of the informed consent form (ICF) until at least 2 months after the last dose of study drug; the definition of adequate contraception will be based on the judgment of the principal investigator or a designated associate
  • Subject must be able to swallow and retain oral medication
  • Patients on pain medications (non-opioids), including nonsteroidal anti-inflammatory drugs (NSAIDS) and acetaminophen, may be enrolled as long as they have been using it chronically, at least more than 2 weeks

Who cannot join

  • 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
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  • 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
  • Known history of human immunodeficiency virus (HIV) infection or current chronic or active hepatitis B or C infection requiring treatment with antiviral therapy
  • Ongoing infection > grade 2 NCI-CTCAE v4.0
  • Symptomatic metastatic brain or meningeal tumors
  • Presence of a non-healing wound, non-healing ulcer, or bone fracture
  • Major surgical procedure or significant traumatic injury within 28 days before start of study medication
  • Renal failure requiring hemo-or peritoneal dialysis
  • Dehydration grade > 1 NCI-CTCAE v4.0
  • Patients with seizure disorder requiring medication
  • History of persistent proteinuria >= grade 3 NCI-CTCAE v4.0
  • Interstitial lung disease with ongoing signs and symptoms at the time of informed consent
  • Pleural effusion or ascites that causes respiratory compromise (>= NCI-CTCAE version 4.0 grade 2 dyspnea); a) history of organ allograft (including corneal transplant); b) known or suspected allergy or hypersensitivity to any of the study drugs, study drug classes, or excipients of the formulations given during the course of this trial; c) any malabsorption condition; d) any condition which, in the investigator's opinion, makes the subject unsuitable for trial participation; e) substance abuse, medical, psychological or social conditions that may interfere with the subject's participation in the study or evaluation of the study results
  • Concurrent use of another investigational drug or device therapy (i.e., outside of study treatment) during, or within 4 weeks of trial entry (signing of the informed consent form)
  • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days before start of study medication
  • Therapeutic anticoagulation with vitamin-K antagonists (e.g., warfarin) or with heparins and heparinoids; however, prophylactic anticoagulation as described below is allowed: 1. low dose warfarin (1 mg orally, once daily) with prothrombin time [PT]-INR =< 1.5 x ULN is permitted; we will monitor the PT/INR weekly for patients on warfarin and liver function test every 2 weeks (total bilirubin, and AST (serum glutamic oxaloacetic transaminase [SGOT]) and ALT (serum glutamic pyruvic transaminase [SGPT]) if hepatic metastases are present or if patients are on potentially hepatoxic agents such as acetaminophen or statins; 2. low dose aspirin (=< 100 mg daily); and 3. prophylactic doses of heparin
  • Use of any herbal remedy (e.g. St. John's wort [Hypericum perforatum])
  • Use of dexamethasone for cancer related fatigue

Trial locations and contacts

1 site in 1 country.

United States1 site

  • M D Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

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

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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:

  1. 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.

  1. 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.

Being tested
Ethyl Icosapentate, Exercise Intervention, Laboratory Biomarker Analysis, Placebo, Quality-of-Life Assessment
Medical subject headings
Fatigue

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ethyl IcosapentateDrug

    Also called ICOSAPENT ETHYL

    Given by mouth 2 gm orally daily plus physical activity

  • Exercise InterventionBehavioural

    Complete resistance exercises and undergo walking program

  • Exercise InterventionBehavioural

    Meet with exercise specialist and complete stretching exercises

  • Laboratory Biomarker AnalysisOther

    Correlative studies

  • PlaceboOther

    Also called placebo therapy, PLCB, sham therapy

    Given PO

  • Quality-of-Life AssessmentBehavioural

    Also called Quality of Life Assessment

    Ancillary studies

  • Questionnaire AdministrationOther

    Ancillary studies

Study groups in NCT02940223
Study groupRoleWhat they receive
Group I (ethyl icosapentate, physical activity)ExperimentalPatients 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.
Receives: Drug: Ethyl Icosapentate; Behavioral: Exercise Intervention; Other: Laboratory Biomarker Analysis; Behavioral: Quality-of-Life Assessment; Other: Questionnaire Administration
Group II (placebo, physical activity)ExperimentalPatients 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.
Receives: Behavioral: Exercise Intervention; Other: Laboratory Biomarker Analysis; Other: Placebo; Behavioral: Quality-of-Life Assessment; Other: Questionnaire Administration
Group III (placebo, stretching exercises)ExperimentalPatients 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.
Receives: Behavioral: Exercise Intervention; Other: Laboratory Biomarker Analysis; Other: Placebo; Behavioral: Quality-of-Life Assessment; Other: Questionnaire Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline and at 57±5 days

Secondary outcomes (2)

  1. Edmonton Symptom Assessment System (ESAS) 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.

    Measured: Baseline and at 57±5 days

  2. 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.

    Measured: Baseline and at 57±5 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Oct 2016 (estimated)
  2. Study start16 Mar 2017
  3. Primary completion24 Nov 2020
  4. Study completion24 Nov 2020

Why it stopped: PI is requesting termination (closure) of this study.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02940223
Sponsor's protocol ID
2016-0348
Other IDs
NCI-2016-01932, 2016-0348
Status last verified
May 2021
First submitted
19 Oct 2016
Last updated
10 Jun 2021
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ethyl Icosapentate, Exercise Intervention and Laboratory Biomarker Analysis in people with Advanced Malignant Neoplasm and Fatigue, run by M.D. Anderson Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 24 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 10 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cancer Related Fatigue (time frame: Baseline and at 57±5 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02940223.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2021.

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