Muscadine Grape Extract to Improve Fatigue

NCT04495751 | Completed Early Phase 1 Results DMC FDA Drug

• 4 other identifiers: IRB00067614WFBCCC 98320UL1TR001420P30CA012197
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Fatigue

Keywords

Older; Cancer; Survivors

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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

Study Arms (2)

Muscadine Grape Extract Arm

EXPERIMENTAL

Muscadine grape extract pill (12 week supply)

Dietary Supplement: Muscadine grape extract; Other: Quality of Life Assessment; Other: Questionnaires; Other: Participant Feedback

Placebo Arm

PLACEBO COMPARATOR

Placebo provided (12 week supply)

Drug: Placebo; Other: Quality of Life Assessment; Other: Questionnaires; Other: Participant Feedback

Interventions

Muscadine grape extract DIETARY_SUPPLEMENT

Four pills twice daily

Muscadine Grape Extract Arm

Placebo DRUG

Four pills twice daily.

Placebo Arm

Quality of Life Assessment OTHER

Ancillary studies

Muscadine Grape Extract Arm; Placebo Arm

Questionnaires OTHER

Ancillary studies

Muscadine Grape Extract Arm; Placebo Arm

Participant Feedback OTHER

Ancillary studies

Muscadine Grape Extract Arm; Placebo Arm

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (1)

• 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.

  PMID: 36990930 DERIVED

MeSH Terms

Conditions

Fatigue; Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Results Point of Contact

• Title: Principal Investigator
• Organization: Wake Forest Baptist Comprehensive Cancer Center

hklepin@advocatehealth.org

336-713-5440

Study Officials

• Heidi Klepin, MD, MS

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2020
• First Posted: August 3, 2020
• Study Start: April 20, 2021
• Primary Completion: August 26, 2024
• Study Completion: August 26, 2024
• Last Updated: October 16, 2025
• Results First Posted: October 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)