Muscadine Grape Extract to Improve Fatigue

Early Phase 1CompletedNCT04495751

Wake Forest University Health Sciences64 enrolled

Overview

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.

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. ARM II: Patients receive placebo PO BID for 12 weeks in the absence of disease progression or unacceptable toxicity. After completion of study, patients are followed up for 30 days after the last dose of the study drug.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

Conditions

Fatigue

Interventions

Muscadine grape extractDIETARY_SUPPLEMENT

Four pills twice daily

PlaceboDRUG

Four pills twice daily.

Quality of Life AssessmentOTHER

Ancillary studies

Questionnaires

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, United States

Outcomes

Primary Outcomes

Patient Reported Outcomes Measurement System (PROMIS) Fatigue 7a Questionnaire

(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.

Time frame: At baseline and at 12 weeks

Secondary Outcomes

Pepper Assessment Tool for Disability (PAT-D) Questionnaire - Change From Baseline at 12 Weeks

Pepper Assessment Tool for Disability (PAT-D) will used to assess self-reported physical function. The (PAT-D) is a 19-item survey designed to assess domains of physical function in older adults which contains subscales on mobility, instrumental activities of daily living (IADLs), and basic activities of daily living (ADLs). Participant responses will best describe their ability to perform certain activities of daily living (On a scale of 1 to 5; 1 = usually did with no difficulty to 5 = unable to do. Minimum score of 19, max score of 95. A lower score indicates less difficulty with tasks and better function. Investigators will estimate 95% confidence intervals for the differences between the two groups for the secondary outcomes at 12 weeks reported as mean and standard error scores.

Time frame: At 12 weeks

Short Physical Performance Battery (SPPB)

The Short Physical Performance Battery (SPPB) will be used to objectively assess lower extremity physical function. This validated measure comprises a short walk, repeated chair stands, and balance test. Each section is scored out of 4 points, so the highest total score for the SPPB is 12 points. Score range is 0-12. Poor (0-6), moderate 7-9) and good (10-12). Lower scores on the SPPB have been associated with increased risk of disability, hospitalization and worse survival among older adults with and without cancer. Investigators will estimate 95% confidence intervals for the differences between the two groups for the secondary outcomes at 12 weeks.

Data from ClinicalTrials.gov

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