| Eligibility |
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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
- 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
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