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| ID | Type | Description | Link |
|---|---|---|---|
| WFBCCC 98320 | Other Identifier | Wake Forest Baptist Comprehensive Cancer Center | |
| UL1TR001420 | U.S. NIH Grant/Contract | View source | |
| P30CA012197 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Advancing Translational Sciences (NCATS) | NIH |
| National Cancer Institute (NCI) | NIH |
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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.
Primary Objective: To evaluate whether administration of MGE supplementation decreases PROMIS Fatigue score from baseline to 12 weeks compared to placebo.
Secondary Objective(s)
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Muscadine Grape Extract Arm | Experimental | Muscadine grape extract pill (12 week supply) |
|
| Placebo Arm | Placebo Comparator | Placebo provided (12 week supply) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Muscadine grape extract | Dietary Supplement | Four pills twice daily |
| |
| 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 |
| 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. |
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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:
Ability to understand and the willingness to sign an IRB-approved informed consent document (either directly or via a legally authorized representative).
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Heidi Klepin, MD, MS | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest Baptist Comprehensive Cancer Center | Winston-Salem | North Carolina | 27157 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36990930 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Muscadine Grape Extract Arm | Muscadine grape extract pill (12 week supply) Muscadine grape extract: Four pills twice daily Quality of Life Assessment: Ancillary studies Questionnaires: Ancillary studies Participant Feedback: Ancillary studies |
| FG001 | Placebo Arm | Placebo provided (12 week supply) Placebo: Four pills twice daily. Quality of Life Assessment: Ancillary studies Questionnaires: Ancillary studies Participant Feedback: Ancillary studies |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Muscadine Grape Extract Arm | Muscadine grape extract pill (12 week supply) Muscadine grape extract: Four pills twice daily Quality of Life Assessment: Ancillary studies Questionnaires: Ancillary studies Participant Feedback: Ancillary studies |
| BG001 | Placebo Arm |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Not all participants reported data for this outcome measure. | Posted | Mean | Standard Error | score on a scale | At baseline and at 12 weeks |
|
12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Muscadine Grape Extract Arm | Muscadine grape extract pill (12 week supply) Muscadine grape extract: Four pills twice daily Quality of Life Assessment: Ancillary studies Questionnaires: Ancillary studies Participant Feedback: Ancillary studies |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyperkalemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Principal Investigator | Wake Forest Baptist Comprehensive Cancer Center | 336-713-5440 | hklepin@advocatehealth.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 27, 2021 | Aug 13, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 31, 2024 | Sep 24, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D005221 | Fatigue |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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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.
| Placebo |
| Drug |
Four pills twice daily. |
|
| Quality of Life Assessment | Other | Ancillary studies |
|
| Questionnaires | Other | Ancillary studies |
|
| Participant Feedback | Other | Ancillary studies |
|
| 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 |
Placebo provided (12 week supply) Placebo: Four pills twice daily. Quality of Life Assessment: Ancillary studies Questionnaires: Ancillary studies Participant Feedback: Ancillary studies |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Placebo Arm | Placebo provided (12 week supply) Placebo: Four pills twice daily. Quality of Life Assessment: Ancillary studies Questionnaires: Ancillary studies Participant Feedback: Ancillary studies |
|
|
|
| Secondary | 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. | Not all participants reported data for this outcome measure. | Posted | Mean | Standard Error | mean score on a scale | At 12 weeks |
|
|
|
|
| Secondary | 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. | Posted | Mean | Standard Error | points | At 12 weeks |
|
|
|
|
| Secondary | 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. | Posted | Mean | Standard Error | kcal/week | At 12 weeks |
|
|
|
|
| Secondary | 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. | Not all participants reported data for this outcome measure. | Posted | Mean | Standard Error | meters | At 12 weeks |
|
|
|
|
| Secondary | 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. | Not all participants reported data for this outcome measure. | Posted | Mean | Standard Error | hours | At 12 weeks |
|
|
|
|
| Secondary | 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. | Not all participants reported data for this outcome measure. | Posted | Mean | Standard Error | T score | At 12 weeks |
|
|
|
|
| Secondary | 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. | Not all participants reported data for this outcome measure. | Posted | Mean | Standard Error | number of pills | 12 weeks |
|
|
|
|
| Secondary | 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. | Not all participants reported data for this outcome measure. | Posted | Mean | Standard Error | score on a scale | At 12 weeks |
|
|
|
|
| 0 |
| 32 |
| 0 |
| 32 |
| 29 |
| 32 |
| EG001 | Placebo Arm | Placebo provided (12 week supply) Placebo: Four pills twice daily. Quality of Life Assessment: Ancillary studies Questionnaires: Ancillary studies Participant Feedback: Ancillary studies | 0 | 32 | 1 | 32 | 28 | 32 |
| Abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | Non-systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Fatigue | General disorders | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | Non-systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Rash maculopapular | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Platelet count decreased | Investigations | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | Non-systematic Assessment |
|
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| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| Physical health (t score) |
|
| Mental health (t score) |
|
| Mean Difference (Final Values) |
| 0.1 |
| 2-Sided |
| 95 |
| -0.3 |
| 0.6 |
| Superiority |
Quality of life - Ability to carry out social activities and roles |
| Physical health (t score) | Mean Difference (Final Values) | 0.9 | 2-Sided | 95 | -2.7 | 4.5 | Superiority |
| Global Mental health (t score | Mean Difference (Final Values) | -1.4 | 2-Sided | 95 | -5.4 | 2.5 | Superiority |