Muscadine Grape Extract to Improve Fatigue

Study Overview
=================
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.

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.

Official Title
-----------------
FOCUS - Pilot Study of Muscadine Grape Extract to Improve Fatigue Among Older Adult Cancer Survivors

Conditions
-----------------
Fatigue

Intervention / Treatment
-----------------
* Dietary Supplement: Muscadine grape extract
* Drug: Placebo
* Other: Quality of Life Assessment
* Other: Questionnaires
* Other: Participant Feedback


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Muscadine Grape Extract Arm<br>Muscadine grape extract pill (12 week supply) | Dietary Supplement: Muscadine grape extract<br>* Four pills twice daily<br>Other: Quality of Life Assessment<br>* Ancillary studies<br>Other: Questionnaires<br>* Ancillary studies<br>Other: Participant Feedback<br>* Ancillary studies<br>|
| Placebo Comparator: Placebo Arm<br>Placebo provided (12 week supply) | Drug: Placebo<br>* Four pills twice daily.<br>Other: Quality of Life Assessment<br>* Ancillary studies<br>Other: Questionnaires<br>* Ancillary studies<br>Other: Participant Feedback<br>* Ancillary studies<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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. | At baseline and at 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pepper Assessment Tool for Disability (PAT-D) Questionnaire | 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. | At baseline and 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. | At baseline and 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. Scores for all three tests will be combined. Lower scores on the SPPB have been associated with increased risk of disability, hospitalization and worse survival among older adults with and without cancer. | At baseline and 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). | At baseline and 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. | At baseline and at 12 weeks | 
| 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). | At baseline and at 12 weeks | 
| Adherence - Pill Count | Adherence will be measured by pill count at study completion. | 12 weeks | 
| Fried Frailty Index | Frailty indexes will be assessed for differences between the two arms. | At baseline and at 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Older, Cancer, Survivors