FatigueEarly Phase 1NCT04495751
Muscadine Grape Extract to Improve Fatigue
A Early Phase 1 study testing Muscadine grape extract, Quality of Life Assessment and Questionnaires in people with Fatigue, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Fatigue
- What is being tested?
- Muscadine grape extract, Quality of Life Assessment and Questionnaires
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Apr 2021to 26 Aug 2024
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
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- 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).
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157
About this study
Official title: 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.
Read the 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.
- Conditions
- Fatigue
- Being tested
- Muscadine grape extract, Placebo, Quality of Life Assessment, Questionnaires, Participant Feedback
- Keywords
- Older, Cancer, Survivors
- Medical subject headings
- Fatigue, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Muscadine grape extractDietary supplement
Four pills twice daily
PlaceboDrug
Four pills twice daily.
Quality of Life AssessmentOther
Ancillary studies
QuestionnairesOther
Ancillary studies
Participant FeedbackOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Muscadine Grape Extract Arm | Experimental | Muscadine grape extract pill (12 week supply) Receives: Dietary Supplement: Muscadine grape extract; Other: Quality of Life Assessment; Other: Questionnaires; Other: Participant Feedback |
| Placebo Arm | Placebo comparator | Placebo provided (12 week supply) Receives: Drug: Placebo; Other: Quality of Life Assessment; Other: Questionnaires; Other: Participant Feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline and at 12 weeks
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2020
- Study start20 Apr 2021
- Primary completion26 Aug 2024
- Study completion26 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FatigueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS), National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Heidi Klepin, MD, MS, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04495751
- Sponsor's protocol ID
- IRB00067614
- Other IDs
- WFBCCC 98320, UL1TR001420, P30CA012197
- Status last verified
- Sep 2025
- First submitted
- 28 Jul 2020
- Last updated
- 16 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 36990930
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FOCUS - Pilot Study of Muscadine Grape Extract to Improve Fatigue Among Older Adult Cancer Survivors
- ClinicalTrials.gov ID
- NCT04495751
- Acronym / sponsor ID
- IRB00067614
- Conditions
- Fatigue
- Keywords
- Older, Cancer, Survivors
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS), National Cancer Institute (NCI)
- Study start
- 20 Apr 2021 (actual)
- Primary completion
- 26 Aug 2024 (actual)
- Study completion
- 26 Aug 2024 (actual)
- First posted
- 3 Aug 2020 (actual)
- Results
- Posted 16 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Muscadine Grape Extract Arm | Experimental | Dietary Supplement: Muscadine grape extract, Other: Quality of Life Assessment, Other: Questionnaires, Other: Participant FeedbackMuscadine grape extract pill (12 week supply) |
| Placebo Arm | Placebo comparator | Drug: Placebo, Other: Quality of Life Assessment, Other: Questionnaires, Other: Participant FeedbackPlacebo provided (12 week supply) |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Muscadine grape extractFour pills twice daily | Dietary supplement | Muscadine Grape Extract Arm |
| PlaceboFour pills twice daily. | Drug | Placebo Arm |
| Quality of Life AssessmentAncillary studies | Other | Muscadine Grape Extract Arm, Placebo Arm |
| QuestionnairesAncillary studies | Other | Muscadine Grape Extract Arm, Placebo Arm |
| Participant FeedbackAncillary studies | Other | Muscadine Grape Extract Arm, Placebo Arm |
Primary outcome
Patient Reported Outcomes Measurement System (PROMIS) Fatigue 7a Questionnaire
Time frame: At baseline and at 12 weeks
(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.
8 secondary outcomes
Pepper Assessment Tool for Disability (PAT-D) Questionnaire - Change From Baseline at 12 Weeks
Time frame: At 12 weeks
Short Physical Performance Battery (SPPB)
Time frame: At 12 weeks
Short Form Minnesota Leisure Time Activity Questionnaire (MLTA)
Time frame: At 12 weeks
6-Minute Walk Test
Time frame: At 12 weeks
Longitudinal Aging Study Amsterdam (LASA) Sedentary Behavior Questionnaire
Time frame: At 12 weeks
Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Short Form (SF) - Quality of Life
Time frame: At 12 weeks
Adherence - Pill Count
Time frame: 12 weeks
Fried Frailty Index
Time frame: At 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36990930Klepin 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heidi Klepin, MD, MS principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Muscadine grape extract, Quality of Life Assessment and Questionnaires in people with Fatigue, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Reported Outcomes Measurement System (PROMIS) Fatigue 7a Questionnaire (time frame: At baseline and at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04495751, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2025; AzTrials last refreshed its copy on 30 Oct 2026.