A Randomized Double-Blind Placebo-Controlled Trial of Fruit and Vegetable Concentrates on Intermediate Biomarkers in Head and Neck Cancer

Mridul Datta, Edward G. Shaw, Glenn J. Lesser, L. Douglas Case, Mara Z. Vitolins, Charles Schneider, Bart Frizzell, Christopher Sullivan, Mark Lively, Elizabeth J Franzmann, Jennifer Hu

Research output: Contribution to journalArticle

Abstract

Background. Head and neck cancer (HNC) patients are at an increased risk for developing second primary tumors (SPTs). Diets rich in fruits and vegetables (FVs) may lower HNC risk. FV concentrates may offer a potential alternative to increasing FV intake. Methods. We conducted a randomized, double-blind, placebo-controlled trial to evaluate whether Juice PLUS+ (JP; a commercial product with multiple FV concentrates) has an effect on p27 and Ki-67, biomarkers associated with the risk of SPTs. During 2004-2008, we randomized 134 HNC patients to 12 weeks of JP (n = 72) or placebo (n = 62). Oral cavity mucosal biopsies and whole blood were obtained at baseline and after 12 weeks. All participants were given the opportunity to receive JP for 5 years following the end of the intervention period, and they were followed yearly for the development of SPTs. Results. After 12 weeks, patients on JP had significantly higher serum α-carotene (P =.009), β-carotene (P <.0001), and lutein (P =.003) but did not differ significantly in p27 (P =.23) or Ki-67 (P =.95). JP use following the initial 12-week trial was not significantly associated with SPT prevention. Conclusions. Despite increased serum micronutrient levels, our results do not suggest a clinical benefit of JP in HNC patients. Future studies should focus on longer intervention periods and/or modified supplement formulations with demonstrated chemopreventive properties.

Original languageEnglish (US)
Pages (from-to)115-123
Number of pages9
JournalIntegrative Cancer Therapies
Volume17
Issue number1
DOIs
StatePublished - Mar 1 2018

Fingerprint

Head and Neck Neoplasms
Vegetables
Fruit
Biomarkers
Placebos
Carotenoids
Neoplasms
Lutein
Micronutrients
Primary Prevention
Serum
Mouth
Diet
Biopsy

Keywords

  • fruit/vegetable concentrate
  • head and neck cancer
  • Ki-67
  • p27
  • surrogate end point biomarkers

ASJC Scopus subject areas

  • Oncology
  • Complementary and alternative medicine

Cite this

A Randomized Double-Blind Placebo-Controlled Trial of Fruit and Vegetable Concentrates on Intermediate Biomarkers in Head and Neck Cancer. / Datta, Mridul; Shaw, Edward G.; Lesser, Glenn J.; Case, L. Douglas; Vitolins, Mara Z.; Schneider, Charles; Frizzell, Bart; Sullivan, Christopher; Lively, Mark; Franzmann, Elizabeth J; Hu, Jennifer.

In: Integrative Cancer Therapies, Vol. 17, No. 1, 01.03.2018, p. 115-123.

Research output: Contribution to journalArticle

Datta, Mridul ; Shaw, Edward G. ; Lesser, Glenn J. ; Case, L. Douglas ; Vitolins, Mara Z. ; Schneider, Charles ; Frizzell, Bart ; Sullivan, Christopher ; Lively, Mark ; Franzmann, Elizabeth J ; Hu, Jennifer. / A Randomized Double-Blind Placebo-Controlled Trial of Fruit and Vegetable Concentrates on Intermediate Biomarkers in Head and Neck Cancer. In: Integrative Cancer Therapies. 2018 ; Vol. 17, No. 1. pp. 115-123.
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AU - Lesser, Glenn J.

AU - Case, L. Douglas

AU - Vitolins, Mara Z.

AU - Schneider, Charles

AU - Frizzell, Bart

AU - Sullivan, Christopher

AU - Lively, Mark

AU - Franzmann, Elizabeth J

AU - Hu, Jennifer

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N2 - Background. Head and neck cancer (HNC) patients are at an increased risk for developing second primary tumors (SPTs). Diets rich in fruits and vegetables (FVs) may lower HNC risk. FV concentrates may offer a potential alternative to increasing FV intake. Methods. We conducted a randomized, double-blind, placebo-controlled trial to evaluate whether Juice PLUS+ (JP; a commercial product with multiple FV concentrates) has an effect on p27 and Ki-67, biomarkers associated with the risk of SPTs. During 2004-2008, we randomized 134 HNC patients to 12 weeks of JP (n = 72) or placebo (n = 62). Oral cavity mucosal biopsies and whole blood were obtained at baseline and after 12 weeks. All participants were given the opportunity to receive JP for 5 years following the end of the intervention period, and they were followed yearly for the development of SPTs. Results. After 12 weeks, patients on JP had significantly higher serum α-carotene (P =.009), β-carotene (P <.0001), and lutein (P =.003) but did not differ significantly in p27 (P =.23) or Ki-67 (P =.95). JP use following the initial 12-week trial was not significantly associated with SPT prevention. Conclusions. Despite increased serum micronutrient levels, our results do not suggest a clinical benefit of JP in HNC patients. Future studies should focus on longer intervention periods and/or modified supplement formulations with demonstrated chemopreventive properties.

AB - Background. Head and neck cancer (HNC) patients are at an increased risk for developing second primary tumors (SPTs). Diets rich in fruits and vegetables (FVs) may lower HNC risk. FV concentrates may offer a potential alternative to increasing FV intake. Methods. We conducted a randomized, double-blind, placebo-controlled trial to evaluate whether Juice PLUS+ (JP; a commercial product with multiple FV concentrates) has an effect on p27 and Ki-67, biomarkers associated with the risk of SPTs. During 2004-2008, we randomized 134 HNC patients to 12 weeks of JP (n = 72) or placebo (n = 62). Oral cavity mucosal biopsies and whole blood were obtained at baseline and after 12 weeks. All participants were given the opportunity to receive JP for 5 years following the end of the intervention period, and they were followed yearly for the development of SPTs. Results. After 12 weeks, patients on JP had significantly higher serum α-carotene (P =.009), β-carotene (P <.0001), and lutein (P =.003) but did not differ significantly in p27 (P =.23) or Ki-67 (P =.95). JP use following the initial 12-week trial was not significantly associated with SPT prevention. Conclusions. Despite increased serum micronutrient levels, our results do not suggest a clinical benefit of JP in HNC patients. Future studies should focus on longer intervention periods and/or modified supplement formulations with demonstrated chemopreventive properties.

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