Muscadine Grape Extract to Improve Fatigue

Fatigue Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04495751
• Other study ID #: IRB00067614
• Secondary ID: WFBCCC 98320
• Status: Recruiting
• Phase: Early Phase 1
• Start date: April 20, 2021
• Est. completion date: September 2024

Study information

• Verified date: April 2024
• Source: Wake Forest University Health Sciences
• Contact: Katherine Pleasant, BA
• Phone: 336-713-5045
• Email: kpleasan[@]wakehealth.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: September 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fatigue

Intervention

Dietary Supplement:
• Muscadine grape extract
Four pills twice daily

Drug:
• Placebo
Four pills twice daily.

Other:
• Quality of Life Assessment
Ancillary studies
• Questionnaires
Ancillary studies
• Participant Feedback
Ancillary studies

Locations

Country	Name	City	State
United States	Wake Forest Baptist Comprehensive Cancer Center	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	At baseline and at 12 weeks
Secondary	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
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.	At baseline and 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. 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
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).	At baseline and 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.	At baseline and at 12 weeks
Secondary	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
Secondary	Adherence - Pill Count	Adherence will be measured by pill count at study completion.	12 weeks
Secondary	Fried Frailty Index	Frailty indexes will be assessed for differences between the two arms.	At baseline and at 12 weeks