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.
