A Randomized Phase II Study of the Nutritional Supplements Juice Plus + and Juice Plus + Complete in Ovarian Cancer Patients
Before starting the study, patients will have a dietary pattern evaluation, physical exam,
blood test, height, weight, hip, wrist, mid-arm and waist circumference measurements.
Researchers will compare changes in weight, waist, hip, mid-arm and wrist size, and changes
in the amount of vitamins, iron, and nutrients in the blood. Researchers will also measure
the levels of some proteins that can be linked to ovarian tumors.
Patients will be randomly picked (as in the toss of a coin) to be in one of two groups. One
group will receive free of charge nutritional counseling for 6 months, while the second
group will receive free of charge daily supplements . These supplements will be made up of
a combination from fruits and vegetables (Juice Plus+). Patients will be asked to take two
capsules (Juice Plus+) in the morning, and two capsules (Juice Plus+) along with a drink
containing vitamins and minerals (Juice Plus+ Complete) in the evening for 6 months.
All patients will have their eating patterns monitored for six months. Patients will come
to the clinic at least every three months as part of their normal treatment schedule. Each
visit will take 3 hours and will include a physical exam, blood tests, and anthropometric
measurements (height, weight, waist, hip, mid-arm, and wrist circumferences). At some
visits, dietary and quality of life assessments will also be done.
With the exception of the first interview, nutritional counseling will be mostly done by a
30 to 60 minute telephone call once a week for two months. Counseling will also be done
once every other week for two months and then once a month for two months.
Participation in this study will be stopped if patients have to start being fed by vein,
patients get pregnant or begin breast feeding, patients have bowel obstruction, patients are
diagnosed with a condition requiring a restricted diet, patients begin medication that is
incompatible with a high fiber diet, or patients have severe side effects.
This is an investigational study. A total of 50 patients will take part in this study.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Change in serum lipid peroxide levels resulting from nutritional supplements or dietary counseling
Measurements of serum lipid peroxide and serum carotenoid levels obtained at baseline and at least every 3 months for total of 6 months; 3 measurements per participant used to assess changes in the lipid peroxide and serum carotenoid levels - baseline measurement during and after treatment. Outcome evaluated using repeated measures ANOVA design with 2 groups and 3 time points.
Baeline to 6 months
Lovell A. Jones, PHD, BS, MA
UT MD Anderson Cancer Center
United States: Institutional Review Board
|UT MD Anderson Cancer Center||Houston, Texas 77030|