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Phase I Study of Muscadine Grape Extract for Patients With Advanced Cancer
Rhonda L Bitting1,2, Janet A Tooze1,3, Scott Isom1,3
1Comprehensive Cancer Center.
Objective:
Preclinical studies with muscadine grape extract (MGE) show antitumor activity and decreased systemic inflammation. This phase I study (NCT02583269) assessed safety and tolerability of a proprietary MGE preparation in patients with advanced solid tumors.
Methods:
Patients with metastatic or unresectable cancers who were progressing on standard therapies were assigned to MGE in a standard 3+3 design. Five dose levels were tested (320 to 1600 mg total phenolics/d). Safety and maximum-tolerated dose were assessed after 4 weeks. Patients were evaluated for response at 8 weeks and continued on MGE if clinically stable. Secondary outcomes were response, survival, adherence, fatigue, and quality of life (QOL).
Results:
In total, 23 patients (lung, n=7; gastrointestinal, n=7; genitourinary, n=6; other, n=3) received MGE capsules by mouth twice daily. The cohort [median age 72 years, 48% Eastern Cooperative Oncology Group (ECOG) 2] was heavily pretreated. After 4 weeks on MGE, possibly attributable adverse events grade 2 or higher were fatigue (n=1), decreased lymphocyte count (n=1), and constipation (n=2), including 1 dose-limiting toxicity for grade 3 constipation. Maximum-tolerated dose was not reached. No partial responses were observed. Median time on therapy was 8 weeks, with 29% of patients treated beyond 16 weeks and a median overall survival of 7.2 months. QOL and fatigue levels were stable from baseline to 8 weeks. Higher MGE dose was correlated with improvement in self-reported physical well-being QOL at 8 weeks (r=0.6; P=0.04).
Conclusions:
MGE is safe and well-tolerated in heavily pretreated and older cancer patients. The potential anticancer properties and the effects of MGE on physical well-being and QOL metrics will be evaluated in future studies.
Insights
Muscadine grape extract (MGE) is safe for advanced cancer patients. Future studies will explore its anticancer potential and effects on quality of life.
Area of Science:
- Oncology
- Pharmacology
- Nutraceuticals
Background:
- Preclinical studies indicate muscadine grape extract (MGE) possesses antitumor properties and reduces systemic inflammation.
- This study investigates the safety and tolerability of a specific MGE preparation in patients with advanced solid tumors.
Purpose of the Study:
- To assess the safety and tolerability of a proprietary muscadine grape extract (MGE) in patients with advanced solid tumors.
- To determine the maximum-tolerated dose (MTD) and evaluate preliminary efficacy and patient-reported outcomes.
Main Methods:
- A Phase I, 3+3 dose-escalation study (NCT02583269) involving 23 patients with advanced solid tumors.
- MGE was administered orally at doses ranging from 320 to 1600 mg total phenolics/day.
- Safety, maximum-tolerated dose, response rates, survival, adherence, fatigue, and quality of life (QOL) were assessed.
Main Results:
- MGE was generally safe and well-tolerated in heavily pretreated, older cancer patients.
- The maximum-tolerated dose was not reached; dose-limiting toxicity was grade 3 constipation.
- Median overall survival was 7.2 months, with no partial responses observed. Higher MGE doses correlated with improved QOL physical well-being.
Conclusions:
- Muscadine grape extract (MGE) demonstrates a favorable safety profile in patients with advanced cancer.
- MGE shows potential for improving quality of life, particularly physical well-being.
- Further investigation into the anticancer efficacy and therapeutic benefits of MGE is warranted.
