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Clinical Trial
. 2021 Jun 1;44(6):239-246.
doi: 10.1097/COC.0000000000000814.

Phase I Study of Muscadine Grape Extract for Patients With Advanced Cancer

Rhonda L Bitting  1   2 , Janet A Tooze  1   3 , Scott Isom  1   3 , W Jeffrey Petty  1   2 , Stefan C Grant  1   2 , Rodwige J Desnoyers  1   2 , Alexandra Thomas  1   2 , Christopher Y Thomas  1   2 , Angela T Alistar  1   2 , Shannon L Golden  4 , Katherine Pleasant  4 , Mark C Chappell  4 , E Ann Tallant  1   4 , Patricia E Gallagher  1   4 , Heidi D Klepin  1   2
Affiliations
Clinical Trial

Phase I Study of Muscadine Grape Extract for Patients With Advanced Cancer

Rhonda L Bitting et al. Am J Clin Oncol. .

Abstract

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.

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Conflict of interest statement

The authors declare no conflicts of interest.

Figures

Figure 1.
Figure 1.
In patients remaining on treatment for 12 weeks (n=8), Spearman plot showing (A) the positive correlation between dose level and ranking of quality of life using the FACT-G measure and (B) the negative correlation between dose level and ranking of fatigue using the PROMIS-fatigue measure.
See this image and copyright information in PMC

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