Phase
Condition
Pain (Pediatric)
Treatment
Quality of Life Assessment
Placebo
Participant Feedback
Clinical Study ID
Ages > 65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Self-reported history of cancer diagnosed > 12 months prior to enrollment excludingnon-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. (superficialdisease and in situ disease only is excluded)
Eligible hematologic malignancies include lymphoma any subtype any stage inremission, 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 orvery much" to the screening question "During the past seven days, did you feelfatigued: Not at all, a little bit, somewhat, quite a bit, very much?"
Ability to walk without requiring assistance from another individual (use of cane orwalker acceptable)
Normal organ and marrow function as defined below:
leukocytes >3,000/mcL
absolute neutrophil count >1,500/mcL
platelets >100,000/mcL
total bilirubin within normal institutional limits
AST(SGOT)/ALT(SGPT) <2.5 X institutional upper limit of normal
creatinine clearance >30 mL/min
Ability to understand and the willingness to sign an IRB-approved informed consentdocument (either directly or via a legally authorized representative).
Exclusion
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 (other blood thinners are acceptable)
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 activeinfection, unstable angina pectoris, cardiac arrhythmia, or psychiatricillness/social situations that would limit compliance with study requirements.
Known untreated hypothyroidism
Allergy to muscadine grapes or muscadine grape preparations
Study Design
Study Description
Connect with a study center
Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina 27157
United StatesSite Not Available
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