FOCUS - Pilot Study of Muscadine Grape Extract to Improve Fatigue Among Older Adult Cancer Survivors
Trial Snapshot
- Phase
- Early Phase 1
- Status
- Completed
- Enrollment
- 64
- Locations
- 1
- Primary Endpoint
- Patient Reported Outcomes Measurement System (PROMIS) Fatigue 7a Questionnaire
Study Overview
Brief 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.
Detailed Description
Primary Objective: To evaluate whether administration of MGE supplementation decreases PROMIS Fatigue score from baseline to 12 weeks compared to placebo.
Secondary Objective(s)
- To evaluate whether administration of muscadine grape extract supplementation (4 tablets twice daily) causes changes in physical function (Pepper Assessment Tool for Disability [PAT-D], Short Physical Performance Battery), physical fitness (6-minute walk), physical activity (Minnesota Leisure Questionnaire), sedentary behavior (Sedentary Behavior Questionnaire) from baseline to 12 weeks compared to placebo.
- To compare changes in health related quality of life (PROMIS Global Health) at 12 weeks in participants randomized to muscadine grape extract group vs. placebo.
- To compare changes in the Fried frailty index at 12 weeks in participants randomized to muscadine grape extract vs. placebo.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive muscadine grape extract orally (PO) twice daily (BID) for 12 weeks in the absence of disease progression or unacceptable toxicity.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Participant, Investigator)
Masking Description
This is a double blind study. Only the investigational pharmacists and the statisticians will be unblinded. The blind will be maintained until the study is complete.
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Muscadine Grape Extract Arm
Muscadine grape extract pill (12 week supply)
Intervention: Muscadine grape extract (Dietary Supplement)
Muscadine Grape Extract Arm
Muscadine grape extract pill (12 week supply)
Intervention: Quality of Life Assessment (Other)
Muscadine Grape Extract Arm
Muscadine grape extract pill (12 week supply)
Intervention: Questionnaires (Other)
Muscadine Grape Extract Arm
Muscadine grape extract pill (12 week supply)
Intervention: Participant Feedback (Other)
Placebo Arm
Placebo provided (12 week supply)
Intervention: Placebo (Drug)
Placebo Arm
Placebo provided (12 week supply)
Intervention: Quality of Life Assessment (Other)
Placebo Arm
Placebo provided (12 week supply)
Intervention: Questionnaires (Other)
Placebo Arm
Placebo provided (12 week supply)
Intervention: Participant Feedback (Other)
Outcomes
Primary Outcomes
Patient Reported Outcomes Measurement System (PROMIS) Fatigue 7a Questionnaire
Time Frame: At baseline and at 12 weeks
(PROMIS) Fatigue 7a will be used to assess fatigue. Using a mixed effects model with a constraint of a common baseline mean across treatment groups and an unstructured covariance matrix to model all fatigue measures over time, and use linear contrasts to estimate the difference in change and corresponding 90% confidence interval between the two groups. Item responses are rated on a five-point scale ranging from "never" to "always" and are summed for a total score and transformed to a T-score metric, which has a mean of 50 and a standard deviation of 10. Higher scores indicate more fatigue.
Secondary Outcomes
- Pepper Assessment Tool for Disability (PAT-D) Questionnaire - Change From Baseline at 12 Weeks(At 12 weeks)
- Short Physical Performance Battery (SPPB)(At 12 weeks)
- Short Form Minnesota Leisure Time Activity Questionnaire (MLTA)(At 12 weeks)
- 6-Minute Walk Test(At 12 weeks)
- Longitudinal Aging Study Amsterdam (LASA) Sedentary Behavior Questionnaire(At 12 weeks)
- Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Short Form (SF) - Quality of Life(At 12 weeks)
- Adherence - Pill Count(12 weeks)
- Fried Frailty Index(At 12 weeks)