Juice Plus+ and Juice Plus+ Complete in Ovarian Cancer

NCT ID: NCT01439659

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-02-18
• Study Completion Date: 2026-03-01

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.

Conditions

Ovarian Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Nutritional Counseling

For 6 months control group receives dietary counseling.

Group Type: OTHER

Nutritional Counseling

Intervention Type: BEHAVIORAL

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.

Daily Supplements

2 capsules (Juice Plus+) twice a day (morning and evening) plus Juice Plus+ Complete drink each evening for 6 months.

Group Type: EXPERIMENTAL

Daily Supplements

Intervention Type: DIETARY_SUPPLEMENT

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.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Natural Alternatives International

UNKNOWN

Sponsor Role: collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Beverly C. Handy, MD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Countries

United States

Related Links

http://www.mdanderson.org

University of Texas MD Anderson Cancer Center Website

Other Identifiers

NCI-2011-03303

Identifier Type: REGISTRY

Identifier Source: secondary_id

ID00-420

Identifier Type: -

Identifier Source: org_study_id