Muscadine Grape Extract to Improve Fatigue

FOCUS - Pilot Study of Muscadine Grape Extract to Improve Fatigue Among Older Adult Cancer Survivors

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.

Study Overview

• Status: Completed
• Conditions: Fatigue
• Intervention / Treatment: Other: Quality of Life Assessment; Dietary supplement: Muscadine grape extract; Other: Questionnaires; Other: Participant Feedback; Drug: Placebo

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.

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
• Enrollment (Actual): 64
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest Baptist Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 61 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Muscadine Grape Extract Arm; Muscadine grape extract pill (12 week supply)	Other: Quality of Life Assessment; Ancillary studies; Dietary supplement: Muscadine grape extract; Four pills twice daily; Other: Questionnaires; Ancillary studies; Other: Participant Feedback; Ancillary studies
Placebo Comparator: Placebo Arm; Placebo provided (12 week supply)	Other: Quality of Life Assessment; Ancillary studies; Other: Questionnaires; Ancillary studies; Other: Participant Feedback; Ancillary studies; Drug: Placebo; Four pills twice daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At baseline and at 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	At 12 weeks
Short Form Minnesota Leisure Time Activity Questionnaire (MLTA)	This questionnaire will assess self-reported physical activity with participants answering yes/no questions in regards to physical activities done in the past two weeks and the frequency of those activities. Score is interpreted by calculating the total energy expenditure based on the frequency and duration of reported leisure activities, with higher scores indicating a greater level of physical activity; generally, scores are categorized as low (inactive), moderate (moderately active), and high (highly active). Investigators will estimate 95% confidence intervals for the differences between the two groups for the secondary outcomes at 12 weeks.	At 12 weeks
6-Minute Walk Test	A 6-minute walk will be measured to assess physical fitness. The 6-minute walk is easy to administer in a clinical setting, accurately assesses submaximal exercise capacity, is an independent predictor of mortality and is correlated with peak V02 testing. The number of laps and distance walked on the final lap will be recorded. The total distance the participant walked will be entered onto the online database (1 lap = 30 meters distance). Investigators will estimate 95% confidence intervals for the differences between the two groups for the secondary outcomes at 12 weeks.	At 12 weeks
Longitudinal Aging Study Amsterdam (LASA) Sedentary Behavior Questionnaire	The questionnaire will be used to measure sedentary behavior for time spent during a 24 hour period for weekday and weekend various activities. The questionnaire consists of 10 items. The average time per 24 hours on each sedentary activity will be recorded in hours and/or minutes. Scores represent the self-reported average time an older adult spends engaged in sedentary activities (i.e., watching TV, reading, or sitting during a typical weekday and weekend day), with higher scores indicating a greater amount of time spent sedentary. Investigators will estimate 95% confidence intervals for the differences between the two groups for the secondary outcomes at 12 weeks.	At 12 weeks
Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Short Form (SF) - Quality of Life	The PROMIS Global Health Short Form (SF) is a 10-item questionnaire that will assess global quality of life including overall physical health, mental health, social health, pain, fatigue an overall perceived quality of life. Participants will respond to questions or statements with varied selections (excellent to poor; completely to not at all; never to always; and none to very severe). Scores above 50 are considered a better than average quality of life and scores below 50 are considered below average quality of life. Higher T-scores indicate better health, so scores around 50 are average, while scores below 40 suggest poor health warranting further assessment, and scores above 60 indicate excellent health. 50 indicates the population mean with a standard deviation of 10 Investigators will estimate 95% confidence intervals for the differences between the two groups for the secondary outcomes at 12 weeks.	At 12 weeks
Adherence - Pill Count	Adherence will be measured by pill count at study completion. Investigators will estimate 95% confidence intervals for the differences between the two groups for the secondary outcomes at 12 weeks.	12 weeks
Fried Frailty Index	Frailty indexes will be assessed for differences between the two arms. The Fried frailty index is a scoring system that classifies people into three stages of frailty based on five criteria: weight loss, exhaustion, low physical activity, and slowness. Frailty index scores can be calculated by dividing the sum of the recoded values of the variables by the number of variables measured for a person. Corresponding scores are: Score of 0, non-frail; score of 1-2 pre-frail; score of 3-5 frail. Higher scores represent higher rates of frailty among participants. Investigators will estimate 95% confidence intervals for the differences between the two groups for the secondary outcomes at 12 weeks.	At 12 weeks

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: National Cancer Institute (NCI); National Center for Advancing Translational Sciences (NCATS)
• Investigators: Principal Investigator: Heidi Klepin, MD, MS, Wake Forest University Health Sciences

Publications and helpful links

General Publications

• Klepin HD, Tooze JA, Bitting RL, Davis B, Pleasant K, Melo AC, Cook K, Soto-Pantoja DR, Tallant EA, Gallagher PE. Study design and methods for the pilot study of muscadine grape extract supplement to improve fatigue among older adult cancer survivors (FOCUS) trial. J Geriatr Oncol. 2023 May;14(4):101478. doi: 10.1016/j.jgo.2023.101478. Epub 2023 Mar 27.

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2021
• Primary Completion (Actual): August 26, 2024
• Study Completion (Actual): August 26, 2024

Study Registration Dates

• First Submitted: July 28, 2020
• First Submitted That Met QC Criteria: July 28, 2020
• First Posted (Actual): August 3, 2020

Study Record Updates

• Last Update Posted (Estimated): October 16, 2025
• Last Update Submitted That Met QC Criteria: September 29, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Cancer; Older; Survivors
• Additional Relevant MeSH Terms: Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neoplasms; Fatigue; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Surveys and Questionnaires
• Other Study ID Numbers: IRB00067614; P30CA012197 (U.S. NIH Grant/Contract); WFBCCC 98320 (Other Identifier: Wake Forest Baptist Comprehensive Cancer Center); UL1TR001420 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No