Juice Plus+ and Juice Plus+ Complete in Ovarian Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Natural Alternatives International
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01439659
First received: September 21, 2011
Last updated: March 12, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Ovarian Cancer
Behavioral: Nutritional Counseling
Dietary Supplement: Daily Supplements
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Phase II Study of the Nutritional Supplements Juice Plus + and Juice Plus + Complete in Ovarian Cancer Patients

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Change in serum lipid peroxide levels resulting from nutritional supplements or dietary counseling [ Time Frame: Baeline to 6 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 75
Study Start Date: February 2003
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Nutritional Counseling
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.

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

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01439659

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Natural Alternatives International
Investigators
Principal Investigator: Beverly C. Handy, MD UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01439659     History of Changes
Other Study ID Numbers: ID00-420
Study First Received: September 21, 2011
Last Updated: March 12, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Ovarian Cancer
Epithelial ovarian cancer
First clinical remission
Nutritional Supplements
Juice Plus +
Juice Plus + Complete
Dietary counseling

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders

ClinicalTrials.gov processed this record on July 29, 2014