Muscadine Grape Extract to Improve Fatigue

• Status: Recruiting
• Trial end date: 2022-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this research is to see if muscadine grape extract improves fatigue in people age 70 and above who have a history of treated cancer and report the symptom of fatigue.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wake Forest University Health Sciences

Criteria

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)

• 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 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 (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 active infection, 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