Clinical trial NCT01439659: Juice Plus+ and Juice Plus+ Complete in Ovarian Cancer
Official title: A Randomized Phase II Study of the Nutritional Supplements Juice Plus + and Juice Plus + Complete in Ovarian Cancer Patients
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Ovarian Cancer
Keywords: Ovarian Cancer
Epithelial ovarian cancer
First clinical remission
Nutritional Supplements
Juice Plus +
Juice Plus + Complete
Dietary counseling
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: Natural Alternatives International
First posted: 2011-09-23
Enrollment: 75
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical research study is to see if ovarian cancer patients who add Juice PLus+ and Juice Plus+ Complete to their diets have better outcomes when compared to ovarian cancer patients who receive only dietary counseling alone.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Body Mass Index (BMI) \> 19.5
2. Epithelial ovarian cancer of (any tumor type). Stages 2 and up.
3. In first clinical remission. (CA125 \< 35)
4. \> 21 years of age.
5. CT scan of abdomen/pelvis without evidence of ovarian cancer.
6. Ambulatory/mobile and able to eat/not on parenteral nutrition.
7. Life expectancy of at least 6 months.
8. Informed consent signed indicating patient's knowledge of the investigational nature of the study.

Exclusion Criteria:

1. Evidence of bowel obstruction.
2. Pregnant or lactating.
3. Diagnosed with a co-morbidity requiring a restricted diet or medication for which a high fiber diet may be contraindicated.

Primary outcomes:
measure: Change in serum lipid peroxide levels resulting from nutritional supplements or dietary counseling
timeFrame: Baseline to 6 months
measure: Change in levels of serum carotenoid resulting from nutritional supplements or dietary counseling
timeFrame: Baseline to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Beverly C. Handy, MD
role: PRINCIPAL_INVESTIGATOR
References: