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

75 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the treatment Juice Plus+ and Juice Plus+ Complete for ovarian cancer?

Research suggests that diets high in fruits, vegetables, and antioxidants like vitamins C and E may reduce the risk of ovarian cancer. Juice Plus+ products, which are rich in these nutrients, could potentially offer similar benefits, although direct evidence for their effectiveness in treating ovarian cancer is not yet available. ^{1 2 3 4 5}

Is Juice Plus+ safe for humans?

The research does not specifically mention Juice Plus+ or its safety, but it discusses the safety of antioxidant vitamins like C and E, which are generally considered safe and may reduce the risk of ovarian cancer when taken in high amounts. ^{2 3 4 6 7}

How do nutritional supplements differ from other treatments for ovarian cancer?

Nutritional supplements, particularly those high in vitamins C and E, are unique in that they may reduce the risk of ovarian cancer by providing antioxidant protection, which is different from traditional treatments like chemotherapy that target cancer cells directly. These supplements are taken orally and focus on improving overall nutrition and reducing malnutrition, especially during chemotherapy. ^{2 3 6 8 9}

What is the purpose of this trial?

This trial is testing if ovarian cancer patients who take fruit and vegetable supplements, along with a vitamin and mineral drink, have better health outcomes. The supplements aim to boost nutrition and possibly impact proteins related to tumors.

Research Team

Beverly C. Handy, MD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Nutritional Interventions to Improve Clinical Outcomes in Ovarian Cancer: A Systematic Review of Randomized Controlled Trials. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Intakes of selected nutrients and food groups and risk of ovarian cancer. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Dietary antioxidants, supplements, and risk of epithelial ovarian cancer. [2015]

4. United States pubmed.ncbi.nlm.nih.gov

Carotenoids, antioxidants and ovarian cancer risk in pre- and postmenopausal women. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Assessment of preoperative nutritional status using BIA-derived phase angle (PhA) in patients with advanced ovarian cancer: Correlation with the extent of cytoreduction and complications. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Nutrient intake and ovarian cancer. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Supplemental Selenium May Decrease Ovarian Cancer Risk in African-American Women. [2023]

8. Switzerland pubmed.ncbi.nlm.nih.gov

The Effect of Nutrition Intervention With Oral Nutritional Supplements on Ovarian Cancer Patients Undergoing Chemotherapy. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

The role of antioxidants and vitamin A in ovarian cancer: results from the Women's Health Initiative. [2022]