Juice Plus+ and Juice Plus+ Complete in Ovarian Cancer
Status: | Active, not recruiting |
---|---|
Conditions: | Ovarian Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 21 - Any |
Updated: | 4/17/2018 |
Start Date: | February 2003 |
End Date: | February 2021 |
A Randomized Phase II Study of the Nutritional Supplements Juice Plus + and Juice Plus + Complete in Ovarian Cancer Patients
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.
PLus+ and Juice Plus+ Complete to their diets have better outcomes when compared to ovarian
cancer patients who receive only dietary counseling alone.
Before starting the study, patients will have a dietary pattern evaluation, physical exam,
blood test, height, weight, hip, wrist, mid-arm and waist circumference measurements.
Researchers will compare changes in weight, waist, hip, mid-arm and wrist size, and changes
in the amount of vitamins, iron, and nutrients in the blood. Researchers will also measure
the levels of some proteins that can be linked to ovarian tumors.
Patients will be randomly picked (as in the toss of a coin) to be in one of two groups. One
group will receive free of charge nutritional counseling for 6 months, while the second group
will receive free of charge daily supplements . These supplements will be made up of a
combination from fruits and vegetables (Juice Plus+). Patients will be asked to take two
capsules (Juice Plus+) in the morning, and two capsules (Juice Plus+) along with a drink
containing vitamins and minerals (Juice Plus+ Complete) in the evening for 6 months.
All patients will have their eating patterns monitored for six months. Patients will come to
the clinic at least every three months as part of their normal treatment schedule. Each visit
will take 3 hours and will include a physical exam, blood tests, and anthropometric
measurements (height, weight, waist, hip, mid-arm, and wrist circumferences). At some visits,
dietary and quality of life assessments will also be done.
With the exception of the first interview, nutritional counseling will be mostly done by a 30
to 60 minute telephone call once a week for two months. Counseling will also be done once
every other week for two months and then once a month for two months.
Participation in this study will be stopped if patients have to start being fed by vein,
patients get pregnant or begin breast feeding, patients have bowel obstruction, patients are
diagnosed with a condition requiring a restricted diet, patients begin medication that is
incompatible with a high fiber diet, or patients have severe side effects.
This is an investigational study. A total of 50 patients will take part in this study.
blood test, height, weight, hip, wrist, mid-arm and waist circumference measurements.
Researchers will compare changes in weight, waist, hip, mid-arm and wrist size, and changes
in the amount of vitamins, iron, and nutrients in the blood. Researchers will also measure
the levels of some proteins that can be linked to ovarian tumors.
Patients will be randomly picked (as in the toss of a coin) to be in one of two groups. One
group will receive free of charge nutritional counseling for 6 months, while the second group
will receive free of charge daily supplements . These supplements will be made up of a
combination from fruits and vegetables (Juice Plus+). Patients will be asked to take two
capsules (Juice Plus+) in the morning, and two capsules (Juice Plus+) along with a drink
containing vitamins and minerals (Juice Plus+ Complete) in the evening for 6 months.
All patients will have their eating patterns monitored for six months. Patients will come to
the clinic at least every three months as part of their normal treatment schedule. Each visit
will take 3 hours and will include a physical exam, blood tests, and anthropometric
measurements (height, weight, waist, hip, mid-arm, and wrist circumferences). At some visits,
dietary and quality of life assessments will also be done.
With the exception of the first interview, nutritional counseling will be mostly done by a 30
to 60 minute telephone call once a week for two months. Counseling will also be done once
every other week for two months and then once a month for two months.
Participation in this study will be stopped if patients have to start being fed by vein,
patients get pregnant or begin breast feeding, patients have bowel obstruction, patients are
diagnosed with a condition requiring a restricted diet, patients begin medication that is
incompatible with a high fiber diet, or patients have severe side effects.
This is an investigational study. A total of 50 patients will take part in this study.
Inclusion Criteria:
1. Body Mass Index (BMI) > 19.5
2. Epithelial ovarian cancer of (any tumor type). Stages 2 and up.
3. In first clinical remission. (CA125 < 35)
4. > 21 years of age.
5. CT scan of abdomen/pelvis without evidence of ovarian cancer.
6. Ambulatory/mobile and able to eat/not on parenteral nutrition.
7. Life expectancy of at least 6 months.
8. Informed consent signed indicating patient's knowledge of the investigational nature
of the study.
Exclusion Criteria:
1. Evidence of bowel obstruction.
2. Pregnant or lactating.
3. Diagnosed with a co-morbidity requiring a restricted diet or medication for which a
high fiber diet may be contraindicated.
We found this trial at
1
site
1515 Holcombe Blvd
Houston, Texas 77030
Houston, Texas 77030
713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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