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Grape extract shows promise for fatigue in older cancer survivors

NCT ID NCT04495751

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

64 people

The number who actually took part.

Started

Apr 2021

Finished

Aug 2024

Lead sponsor

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

65 years and older

Sex

Anyone

Healthy volunteers

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

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.

Fatigue neoplasm

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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Other studies related to the condition(s) this trial covers.