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Cancer Supplement

Muscadine Grape Skin Extract for Cancer

Phase 1
Waitlist Available
Led By Heidi Klepin
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years
Awards & highlights

Study Summary

This trial is testing the side effects and best dosage of a supplement made from muscadine grape skin extract to treat patients with cancer that has spread or can't be removed by surgery.

Eligible Conditions
  • Cancer
  • Malignant Tumor

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Dose-Limiting Toxicity
Secondary outcome measures
Adherence to MGE Treatment, as Measured by Percent of Pills Taken at the End of Every 4 Week Period
Best Response
Change in Component Phenolic Levels in Blood
+12 more

Side effects data

From 2023 Phase 1 trial • 24 Patients • NCT02583269
100%
Lymphocyte count decreased
67%
Hyponatremia
67%
Hyperglycemia
67%
Anemia
33%
Wheezing
33%
Hypotension
33%
Hypocalcemia
33%
Hypomagnesemia
33%
Fatigue
33%
Gait disturbance
33%
Urinary tract infection
33%
Platelet count decreased
33%
Pain in extremity
33%
Delusions
33%
Chronic kidney disease
33%
Cough
33%
Dyspnea
33%
Edema, limbs
33%
Hypoalbuminemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm 3 (Muscadine Grape Skin Extract) 3 Pills Times a Day
Arm 4 (Muscadine Grape Skin Extract) 4 Pills Times a Day
Arm 5 (Muscadine Grape Skin Extract) 5 Pills Times a Day
Arm 1 (Muscadine Grape Skin Extract) 1 Pill Times a Day
Arm 2 (Muscadine Grape Skin Extract) 2 Pills Times a Day

Trial Design

5Treatment groups
Experimental Treatment
Group I: Arm 5 muscadine grape skin extract) 5 pills 2 times a dayExperimental Treatment3 Interventions
Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity.
Group II: Arm 4 (muscadine grape skin extract) 4 pills 2 times a dayExperimental Treatment3 Interventions
Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity.
Group III: Arm 3 (muscadine grape skin extract) 3 pills 2 times a dayExperimental Treatment3 Interventions
Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity.
Group IV: Arm 2 (muscadine grape skin extract) 2 pills 2 times a dayExperimental Treatment3 Interventions
Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity.
Group V: Arm 1 (muscadine grape skin extract) 1 pill 2 times a dayExperimental Treatment3 Interventions
Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Laboratory Biomarker Analysis
2010
Completed Phase 2
~840
Muscadine Grape Skin Extract
2016
Completed Phase 1
~30
Quality-of-Life Assessment
2017
Completed Phase 3
~4950

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,243 Previous Clinical Trials
1,004,702 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,667 Previous Clinical Trials
40,926,142 Total Patients Enrolled
Heidi KlepinPrincipal InvestigatorWake Forest University Health Sciences
2 Previous Clinical Trials
115 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
American Journal of Clinical OncologyJournal
Phase I Study of Muscadine Grape Extract for Patients with Advanced Cancer
Bitting, Rhonda L., Janet A. Tooze, Scott Isom, W. Jeffrey Petty, Stefan C. Grant, Rodwige J. Desnoyers, Alexandra Thomas, et al.. 2021. “Phase I Study of Muscadine Grape Extract for Patients with Advanced Cancer”. American Journal of Clinical Oncology. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/coc.0000000000000814.
clinicaltrials.govStudy
Muscadine Grape Skin Extract in Treating Patients With Malignancy That Is Metastatic or Cannot Be Removed by Surgery
2016. "Muscadine Grape Skin Extract in Treating Patients With Malignancy That Is Metastatic or Cannot Be Removed by Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02583269.
~3 spots leftby Apr 2025
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