Muscadine Grape Extract to Improve Fatigue
Primary Purpose
Fatigue
Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Muscadine grape extract
Placebo
Quality of Life Assessment
Questionnaires
Participant Feedback
Sponsored by
About this trial
This is an interventional supportive care trial for Fatigue focused on measuring Older, Cancer, Survivors
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
Sites / Locations
- Wake Forest Baptist Comprehensive Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Muscadine Grape Extract Arm
Placebo Arm
Arm Description
Muscadine grape extract pill (12 week supply)
Placebo provided (12 week supply)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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).
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.
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).
Adherence - Pill Count
Adherence will be measured by pill count at study completion.
Fried Frailty Index
Frailty indexes will be assessed for differences between the two arms.
Full Information
NCT ID
NCT04495751
First Posted
July 28, 2020
Last Updated
August 1, 2023
Sponsor
Wake Forest University Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT04495751
Brief Title
Muscadine Grape Extract to Improve Fatigue
Official Title
FOCUS - Pilot Study of Muscadine Grape Extract to Improve Fatigue Among Older Adult Cancer Survivors
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 20, 2021 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatigue
Keywords
Older, Cancer, Survivors
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
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.
Allocation
Randomized
Enrollment
64 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Muscadine Grape Extract Arm
Arm Type
Experimental
Arm Description
Muscadine grape extract pill (12 week supply)
Arm Title
Placebo Arm
Arm Type
Placebo Comparator
Arm Description
Placebo provided (12 week supply)
Intervention Type
Dietary Supplement
Intervention Name(s)
Muscadine grape extract
Intervention Description
Four pills twice daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Four pills twice daily.
Intervention Type
Other
Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Questionnaires
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Participant Feedback
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Patient Reported Outcomes Measurement System (PROMIS) Fatigue 7a Questionnaire
Description
(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.
Time Frame
At baseline and at 12 weeks
Secondary Outcome Measure Information:
Title
Pepper Assessment Tool for Disability (PAT-D) Questionnaire
Description
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.
Time Frame
At baseline and at 12 weeks
Title
Short Form Minnesota Leisure Time Activity Questionnaire (MLTA)
Description
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.
Time Frame
At baseline and at 12 weeks
Title
Short Physical Performance Battery (SPPB)
Description
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.
Time Frame
At baseline and at 12 weeks
Title
6-Minute Walk Test
Description
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).
Time Frame
At baseline and at 12 weeks
Title
Longitudinal Aging Study Amsterdam (LASA) Sedentary Behavior Questionnaire
Description
The questionnaire will be used to measure sedentary behavior for time spent during a 24 hour period for weekday and weekend various activities.
Time Frame
At baseline and at 12 weeks
Title
PROMIS Global Health Short Form (SF) - Quality of Life
Description
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).
Time Frame
At baseline and at 12 weeks
Title
Adherence - Pill Count
Description
Adherence will be measured by pill count at study completion.
Time Frame
12 weeks
Title
Fried Frailty Index
Description
Frailty indexes will be assessed for differences between the two arms.
Time Frame
At baseline and at 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Katherine Pleasant, BA
Phone
336-713-5045
Email
kpleasan@wakehealth.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Brittany M Davis, MDiv
Phone
336-716-3906
Email
bmdavis@wakehealth.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heidi Klepin, MD, MS
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest Baptist Comprehensive Cancer Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Email
sgolden@wakehealth.edu
First Name & Middle Initial & Last Name & Degree
Heidi Klepin, MD, MS
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Muscadine Grape Extract to Improve Fatigue
We'll reach out to this number within 24 hrs