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A Randomized Phase II Study of the Nutritional Supplements Juice Plus + and Juice Plus + Complete in Ovarian Cancer Patients

Phase 2
21 Years
Open (Enrolling)
Ovarian Cancer

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Trial Information

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.

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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Change in serum lipid peroxide levels resulting from nutritional supplements or dietary counseling

Outcome Description:

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.

Outcome Time Frame:

Baeline to 6 months

Safety Issue:


Principal Investigator

Lovell A. Jones, PHD, BS, MA

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

February 2003

Completion Date:

Related Keywords:

  • Ovarian Cancer
  • Ovarian Cancer
  • Epithelial ovarian cancer
  • First clinical remission
  • Nutritional Supplements
  • Juice Plus +
  • Juice Plus + Complete
  • Dietary counseling
  • Ovarian Neoplasms



UT MD Anderson Cancer Center Houston, Texas  77030