Juice Plus+ and Juice Plus+ Complete in Ovarian Cancer
|Ovarian Cancer||Behavioral: Nutritional Counseling Dietary Supplement: Daily Supplements||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
|Official Title:||A Randomized Phase II Study of the Nutritional Supplements Juice Plus + and Juice Plus + Complete in Ovarian Cancer Patients|
- Change in serum lipid peroxide levels resulting from nutritional supplements or dietary counseling [ Time Frame: Baseline to 6 months ]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.
- Change in levels of serum carotenoid resulting from nutritional supplements or dietary counseling [ Time Frame: Baseline to 6 months ]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.
|Actual Study Start Date:||February 2003|
|Estimated Study Completion Date:||February 2019|
|Estimated Primary Completion Date:||February 2019 (Final data collection date for primary outcome measure)|
For 6 months control group receives dietary counseling.
Behavioral: Nutritional Counseling
Initial interview and subsequent telephone contact once per week for two months, once every other week for the following two months, and once per month for the remaining two months.
Experimental: Daily Supplements
2 capsules (Juice Plus+) twice a day (morning and evening) plus Juice Plus+ Complete drink each evening for 6 months.
Dietary Supplement: Daily Supplements
Two capsules daily in the morning and two capsules daily in the evening of Juice Plus+ in addition to regular meal. Also a beverage, Juice Plus+ Complete (a powder mixture to be added to one cup of fluid) daily in the evening.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01439659
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Beverly C. Handy, MD||M.D. Anderson Cancer Center|