Adjuvant Fermented Wheat Germ Extract (Avemar) Nutraceutical Improves Survival of High-Risk Skin Melanoma Patients: A Randomized, Pilot, Phase II Clinical Study With a 7-year Follow-Up

Cancer Biother Radiopharm. 2008 Aug;23(4):477-82. doi: 10.1089/cbr.2008.0486.

Abstract

Objective: The fermented wheat germ extract (FWGE) nutraceutical (Avemar), manufactured under "good manufacturing practice" conditions and, fulfilling the self-affirmed "generally recognized as safe" status in the United States, has been approved as a "dietary food for special medical purposes for cancer patients" in Europe. In this paper, we report the adjuvant use of this nutraceutical in the treatment of high-risk skin melanoma patients.

Methods: In a randomized, pilot, phase II clinical trial, the efficacy of dacarbazine (DTIC)-based adjuvant chemotherapy on survival parameters of melanoma patients was compared to that of the same treatment supplemented with a 1-year long administration of FWGE.

Results: At the end of an additional 7-year-long follow-up period, log-rank analyses (Kaplan-Meier estimates) showed significant differences in both progression-free (PFS) and overall survival (OS) in favor of the FWGE group. Mean PFS: 55.8 months (FWGE group) versus 29.9 months (control group), p = 0.0137. Mean OS: 66.2 months (FWGE group) versus 44.7 months (control group), p = 0.0298.

Conclusions: The inclusion of Avemar into the adjuvant protocols of high-risk skin melanoma patients is highly recommended.

Publication types

  • Clinical Trial, Phase II
  • Randomized Controlled Trial

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Chemotherapy, Adjuvant / methods
  • Dacarbazine / adverse effects
  • Dacarbazine / therapeutic use
  • Dietary Supplements*
  • Drug Therapy, Combination
  • Female
  • Fermentation
  • Follow-Up Studies
  • Humans
  • Kaplan-Meier Estimate
  • Male
  • Melanoma / drug therapy*
  • Melanoma / pathology
  • Middle Aged
  • Pilot Projects
  • Plant Extracts / administration & dosage
  • Plant Extracts / adverse effects
  • Plant Extracts / therapeutic use*
  • Skin Neoplasms / drug therapy*
  • Skin Neoplasms / pathology
  • Treatment Outcome
  • Triticum / chemistry*
  • Triticum / metabolism

Substances

  • Plant Extracts
  • Dacarbazine