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

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Muscadine grape extract (MGE) is safe for advanced cancer patients. Future studies will explore its anticancer potential and effects on quality of life.

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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.