Nutritional Supplements for Ovarian Cancer

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Bowel obstruction, Pregnant, Restricted diet, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether adding Juice Plus+ supplements to the diet of ovarian cancer patients can improve health outcomes compared to receiving only dietary advice. One group will take Juice Plus+ capsules and a drink daily, while the other group will receive dietary counseling only. The study seeks women with epithelial ovarian cancer who are in their first remission (cancer is under control) and can move around and eat normally. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you have a condition that requires a restricted diet or medication that conflicts with a high fiber diet, you may not be eligible to participate.

Is there any evidence suggesting that Juice Plus+ and Juice Plus+ Complete are likely to be safe for humans?

Research shows that Juice Plus+ and Juice Plus+ Complete are usually easy for people to take. One study found that 94% of participants adhered to their Juice Plus+ routine, suggesting it was easy to follow. Although limited scientific research exists specifically on Juice Plus+, these supplements contain vitamins like vitamin C, which are generally safe in normal amounts. Detailed reports of serious side effects have not emerged, but it's important to note that research is still limited. As this trial is in an early stage, researchers are still learning about its safety. Prospective participants should consult their doctor about any concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Juice Plus+ and Juice Plus+ Complete for ovarian cancer because, unlike traditional chemotherapy or targeted therapies, these are nutritional supplements that harness the power of concentrated fruits and vegetables. This treatment approach is unique as it combines the benefits of whole food nutrition with a convenient capsule and drink format, potentially offering a gentler alternative with fewer side effects. Additionally, by boosting overall nutrition and supporting the body's defenses, these supplements might enhance the effectiveness of existing treatments, aiming for a holistic approach to cancer management.

What evidence suggests that Juice Plus+ and Juice Plus+ Complete might be effective for ovarian cancer?

Research suggests that Juice Plus+ and Juice Plus+ Complete, studied in this trial, might improve health for ovarian cancer patients. Participants in the "Daily Supplements" arm will receive these supplements, which contain fruit and vegetable concentrates that can increase levels of antioxidants called carotenoids in the body. Higher levels of these antioxidants often link to better health and may help the body fight cancer. Early findings indicate that these supplements could support the immune system, possibly aiding patients in managing the disease better. While more research is needed to confirm these benefits specifically for ovarian cancer, the ingredients in these supplements are known to have positive health effects. ^{1 2 3 4 6}

Who Is on the Research Team?

Beverly C. Handy, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for women over 21 with epithelial ovarian cancer, stages 2 or higher, who are in their first clinical remission. Participants must be able to eat normally (not on IV nutrition), have a BMI over 19.5, and a life expectancy of at least six months. Pregnant or breastfeeding women, those with bowel obstruction or on restricted diets due to other illnesses cannot join.

Inclusion Criteria

A CT scan of your abdomen and pelvis does not show signs of ovarian cancer.

Your cancer is in its early stage and your CA125 level is less than 35.

A CT scan of your abdomen/pelvis does not show signs of ovarian cancer.

Exclusion Criteria

Pregnant or lactating

I have a blockage in my intestines.

I have a health condition that requires me to follow a special diet or take medication that doesn't allow for high fiber foods.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either nutritional counseling or daily supplements for 6 months

6 months

Visits every 3 months (in-person), weekly to monthly calls for counseling

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Juice Plus+
• Juice Plus+ Complete

Trial Overview The study is testing if adding Juice Plus+ supplements and Juice Plus+ Complete shakes to the diet improves outcomes for ovarian cancer patients compared to just receiving nutritional counseling without these supplements.

How Is the Trial Designed?

Group I: Nutritional Counseling Experimental Treatment 1 Intervention

For 6 months control group receives dietary counseling.

Group II: Daily Supplements Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Natural Alternatives International

Collaborator

Trials

1

Recruited

80+

Published Research Related to This Trial

In a study of 496 women with ovarian cancer and 1,425 control women, higher intakes of dietary fiber, vitamins A and E, carotenoids, and total fruit and vegetable consumption were associated with a significantly reduced risk of ovarian cancer.

Conversely, women in the highest quartile of total energy intake showed a weakly increased risk of ovarian cancer, suggesting that a diet rich in plant foods may help lower the risk of this disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intakes of selected nutrients and food groups and risk of ovarian cancer. McCann, SE., Moysich, KB., Mettlin, C.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT01439659

Juice Plus+ and Juice Plus+ Complete in Ovarian Cancer 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 ...

2. clinicaltrial.be clinicaltrial.be/en/details/12909?per_page=20&only_recruiting=0&only_eligible=0&only_active=0

Juice Plus+ and Juice Plus+ Complete in Ovarian Cancer -... Outcome evaluated using repeated measures ANOVA design with 2 groups and 3 time points. 2. Change in levels of serum carotenoid resulting from ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5501769/

A Randomized Double-Blind Placebo-Controlled Trial ... We conducted a randomized, double-blind, placebo-controlled trial to evaluate whether Juice PLUS+ (JP; a commercial product with multiple FV concentrates) has ...

4. withpower.com withpower.com/trial/phase-3-carcinoma-ovarian-epithelial-1-2003-180b2

Nutritional Supplements for Ovarian Cancer · Info for Participants Trial Overview The study is testing if adding Juice Plus+ supplements and Juice Plus+ Complete shakes to the diet improves outcomes for ovarian cancer patients ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2352578925000438

The role of diet, obesity and body composition in epithelial ... Anderson Cancer Center M.D., 2025. A Randomized Phase II Study of the Nutritional Supplements Juice Plus + and Juice Plus + Complete in Ovarian Cancer Patients.

6. cancernetwork.com cancernetwork.com/view/herbal-supplements-are-marketed-cancer-patients-little-scientific-support-safety-and-effectiveness

Herbal Supplements Are Marketed to Cancer Patients With ... Therefore, the most popular, Juice Plus+, is supported by the least amount of scientific data, and the fifth most popular, mangosteen, has no clinical data to ...