NCT01439659

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for phase_2 ovarian-cancer

Timeline
Completed

Started Feb 2003

Longer than P75 for phase_2 ovarian-cancer

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 18, 2003

Completed
8.6 years until next milestone

First Submitted

Initial submission to the registry

September 21, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 23, 2011

Completed
14.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

January 16, 2026

Status Verified

January 1, 2026

Enrollment Period

23 years

First QC Date

September 21, 2011

Last Update Submit

January 14, 2026

Conditions

Ovarian Cancer

Keywords

Ovarian CancerEpithelial ovarian cancerFirst clinical remissionNutritional SupplementsJuice Plus +Juice Plus + CompleteDietary counseling

Outcome Measures

Primary Outcomes (2)

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

    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.

    Baseline to 6 months

  • Change in levels of serum carotenoid resulting from nutritional supplements or dietary counseling

    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.

    Baseline to 6 months

Study Arms (2)

Nutritional Counseling

OTHER

For 6 months control group receives dietary counseling.

Behavioral: Nutritional Counseling

Daily Supplements

EXPERIMENTAL

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

Dietary Supplement: Daily Supplements

Interventions

Nutritional CounselingBEHAVIORAL

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.

Nutritional Counseling
Daily SupplementsDIETARY_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.

Daily Supplements

Eligibility Criteria

Age21 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Ovarian NeoplasmsCarcinoma, Ovarian Epithelial

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Beverly C. Handy, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2011

First Posted

September 23, 2011

Study Start

February 18, 2003

Primary Completion

March 1, 2026

Study Completion

March 1, 2026

Last Updated

January 16, 2026

Record last verified: 2026-01

Locations

US(1)