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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 6 months
Awards & highlights
Study Summary
This trial will compare the effects of adding Juice Plus+ and Juice Plus+ Complete to the diet of ovarian cancer patients receiving only dietary counseling.
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.Check my eligibility
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.See study design
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 belowSelect...
My ovarian cancer is stage 2 or higher.
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My CA125 levels are below 35, indicating I am in my first clinical remission.
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I am over 21 years old.
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I can walk and eat on my own without needing IV nutrition.
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I am older than 21 years.
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I can walk and eat on my own without needing IV nutrition.
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My ovarian cancer is stage 2 or higher.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in levels of serum carotenoid resulting from nutritional supplements or dietary counseling
Body Weight Changes
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
Find a Location
Who is running the clinical trial?
Natural Alternatives InternationalUNKNOWN
M.D. Anderson Cancer CenterLead Sponsor
2,987 Previous Clinical Trials
1,797,939 Total Patients Enrolled
46 Trials studying Ovarian Cancer
16,660 Patients Enrolled for Ovarian Cancer
Beverly C. Handy, MDPrincipal InvestigatorM.D. Anderson Cancer Center
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Eligibility Criteria:
This trial includes the following eligibility 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.I am older than 21 years.I can walk and eat on my own without needing IV nutrition.You weigh more than what is considered healthy for your height.You are expected to live for at least 6 more months.I have a blockage in my intestines.My CA125 levels are below 35, indicating I am in my first clinical remission.I have a health condition that requires me to follow a special diet or take medication that doesn't allow for high fiber foods.My ovarian cancer is stage 2 or higher.My ovarian cancer is stage 2 or higher.I am over 21 years old.I can walk and eat on my own without needing IV nutrition.
Research Study Groups:
This trial has the following groups:- Group 1: Nutritional Counseling
- Group 2: Daily Supplements
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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