Clinical trial NCT04495751: 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
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Fatigue
Keywords: Older
Cancer
Survivors
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Center for Advancing Translational Sciences (NCATS)
name: National Cancer Institute (NCI)
First posted: 2020-08-03
Enrollment: 64
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Patient Reported Outcomes Measurement System (PROMIS) Fatigue 7a Questionnaire
timeFrame: At baseline and at 12 weeks
Secondary outcomes:
measure: Pepper Assessment Tool for Disability (PAT-D) Questionnaire
timeFrame: At baseline and at 12 weeks
measure: Short Form Minnesota Leisure Time Activity Questionnaire (MLTA)
timeFrame: At baseline and at 12 weeks
measure: Short Physical Performance Battery (SPPB)
timeFrame: At baseline and at 12 weeks
measure: 6-Minute Walk Test
timeFrame: At baseline and at 12 weeks
measure: Longitudinal Aging Study Amsterdam (LASA) Sedentary Behavior Questionnaire
timeFrame: At baseline and at 12 weeks
measure: PROMIS Global Health Short Form (SF) - Quality of Life
timeFrame: At baseline and at 12 weeks
measure: Adherence - Pill Count
timeFrame: 12 weeks
measure: Fried Frailty Index
timeFrame: At baseline and at 12 weeks
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Comprehensive Cancer Center
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Heidi Klepin, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: