Muscadine Grape Extract for the Improvement of Fatigue in Older Cancer Survivors

Inclusion Criteria

• Self reported history of cancer diagnosed > 12 months prior to enrollment excluding non-melanoma skin cancer with no evidence of disease at enrollment
• Eligible solid tumor cancer types include stage 1-3 breast, lung, head and neck, colorectal, anal, prostate, melanoma, bladder/ureteral, esophageal, gastric, pancreatic, kidney, liver/biliary, uterine, cervical, ovarian, sarcoma. (superficial disease and in situ disease only is excluded)
• Eligible hematologic malignancies include lymphoma any subtype any stage in remission, multiple myeloma in remission, leukemia any subtype in remission
• Eligible prior cancer treatment modalities include surgery, radiation, chemotherapy, hormonal therapies, immunotherapy, biologic therapies
• All anti-cancer therapy completed > 12 months prior to enrollment
• Age 65 years and older
• Presence of self-reported fatigue defined by a response of “somewhat, quite a bit or very much” to the screening question “During the past seven days, did you feel fatigued: Not at all, a little bit, somewhat, quite a bit, very much?”
• Ability to walk without requiring assistance from another individual (use of cane or walker acceptable)
• Leukocytes >= 3,000/mcL
• Absolute neutrophil count >= 1,500/mcL
• Platelets >= 100,000/mcL
• Total bilirubin within normal institutional limits
• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< x 2.5 x institutional upper limit of normal
• Creatinine clearance >= 30 mL/min
• Ability to understand and the willingness to sign an Institutional Review Board (IRB)-approved informed consent document (either directly or via a legally authorized representative)

Exclusion Criteria

• Active malignancy or on-going cancer treatment including oral anti-estrogen therapy, immunotherapy, biologic therapy
• Men receiving androgen deprivation therapy
• Use of Coumadin or Warfarin
• Symptomatic congestive heart failure
• Lung disease requiring oxygen
• End stage renal disease requiring dialysis
• Inability to swallow capsules
• Chronic nausea or diarrhea defined by a frequency of >= once per week
• Hemoglobin < 10 g/dl
• Diagnosis of dementia
• Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Known untreated hypothyroidism
• Allergy to muscadine grapes or muscadine grape preparations