What is the mechanism of action of this treatment?

The most common treatments for ovarian cancer include chemotherapy, targeted therapy, and nutritional/antioxidant supplementation. Chemotherapy works by using drugs to kill rapidly dividing cancer cells, while targeted therapy involves drugs that specifically target cancer cell mechanisms, such as angiogenesis or specific genetic mutations. Nutritional and antioxidant supplementation, like Juice Plus+ and Juice Plus+ Complete, aims to support the body's overall health and immune function, potentially reducing side effects and improving outcomes. This is particularly important for ovarian cancer patients as it may enhance their quality of life and complement conventional treatments.

What side effects are associated with this type of intervention?

Common treatments for ovarian cancer include surgery, chemotherapy, and targeted therapy. Chemotherapy, often involving drugs like paclitaxel and carboplatin, can cause side effects such as nausea, vomiting, hair loss, fatigue, and increased risk of infection. Targeted therapies, like PARP inhibitors, may lead to side effects including nausea, fatigue, anemia, and increased risk of infections. Nutritional and antioxidant supplementation, such as Juice Plus+ and Juice Plus+ Complete, are generally considered safe with few reported adverse effects, but their efficacy in improving cancer outcomes remains under investigation.

What prior FDA approvals exist?

FDA-approved treatments for ovarian cancer primarily include chemotherapy agents such as carboplatin and paclitaxel, targeted therapies like bevacizumab, and PARP inhibitors for BRCA-mutated tumors. While there is ongoing research into the potential benefits of nutritional and antioxidant supplementation, such as Juice Plus+ and Juice Plus+ Complete, these have not yet received FDA approval specifically for the treatment of ovarian cancer.

What other types of research exist?

Promising alternatives to Juice Plus+ and Juice Plus+ Complete for ovarian cancer patients include: 1) High-flavanone orange juice, which has been associated with cognitive benefits and may have other health benefits due to its flavonoid content. 2) Pomegranate juice, which has been shown to attenuate oxidative stress responses, potentially beneficial for cancer patients undergoing treatment. 3) Citrus bioflavonoid supplements, which have demonstrated DPP-4 inhibitory activity and may offer additional health benefits.

← Back to Search

Nutritional Supplements for Ovarian Cancer

Phase 2

Waitlist Available

Led By Beverly C. Handy, MD

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Epithelial ovarian cancer of (any tumor type). Stages 2 and up.

In first clinical remission. (CA125 < 35)

Must not have

Evidence of bowel obstruction

Diagnosed with a co-morbidity requiring a restricted diet or medication for which a high fiber diet may be contraindicated

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 6 months

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include digestive issues due to high fiber content in the supplements which might not suit everyone's stomachs especially those with certain medical conditions that require a restricted diet.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My ovarian cancer is stage 2 or higher.

Select...

My CA125 levels are below 35, indicating I am in my first clinical remission.

Select...

I am over 21 years old.

Select...

I can walk and eat on my own without needing IV nutrition.

Select...

I am older than 21 years.

Select...

I can walk and eat on my own without needing IV nutrition.

Select...

My ovarian cancer is stage 2 or higher.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have a blockage in my intestines.

Select...

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 ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Body Weight Changes

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Nutritional CounselingExperimental Treatment1 Intervention

For 6 months control group receives dietary counseling.

Group II: Daily SupplementsExperimental Treatment1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nutritional Counseling

2016

Completed Phase 2

~560

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for ovarian cancer include chemotherapy, targeted therapy, and nutritional/antioxidant supplementation. Chemotherapy works by using drugs to kill rapidly dividing cancer cells, while targeted therapy involves drugs that specifically target cancer cell mechanisms, such as angiogenesis or specific genetic mutations. Nutritional and antioxidant supplementation, like Juice Plus+ and Juice Plus+ Complete, aims to support the body's overall health and immune function, potentially reducing side effects and improving outcomes. This is particularly important for ovarian cancer patients as it may enhance their quality of life and complement conventional treatments.