Grape extract shows promise for fatigue in older cancer survivors
NCT ID NCT04495751
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This pilot study tested whether muscadine grape extract can improve fatigue in people aged 70 and older who have had cancer. 64 participants took either the grape extract or a placebo for 12 weeks. The study measured changes in fatigue and physical function using questionnaires.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- muscadine grape extract
- What this could lead to
- If it works, this could point toward a natural supplement to help reduce fatigue in older cancer survivors.
- What could go wrong
- This is a very early, small pilot study (64 people) with no definitive results yet. The supplement may not work better than a placebo, and individual results may vary.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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64 people
The number who actually took part.
- Started
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Apr 2021
- Finished
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Aug 2024
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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65 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157, United States
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