MDACC Study Summary ID00-420

Study Summary
No. ID00-420:.............Lovell A. Jones......Gynecologic Oncology

Study Summary Title



Study Summary Number:	ID00-420

Study Title:	A Randomized Phase II Study of the Nutritional Supplements Juice Plus + and Juice Plus + Complete in Ovarian Cancer Patients

Physician

New Patient Referral



Name:	Lovell A. Jones	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Gynecologic Oncology	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-3316 Contact us about clinical trials

General Information



Disease Group:		Supported By:	N/A

Phase of Study:	Phase II	Return Visit:	Patients will be evaluate during routine follow-up visits at least every three months for a total of six months.

Treatment Agents:		Home Care:	Supplements will be taken at home.

Treatment Loc:	Independent Multicenter Arrangements

Estimated Length of Stay in Houston:	N/A


Description/ Intervention:	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.

Study Objectives / Outcomes

The primary objective is to determine whether ovarian cancer patients in their first clinical remission who consume the nutrional supplements Juice Plus+ and Juice Plus+ Complete, will have better outcomes than those undergoing dietary counseling alone, on the following measures:
1. Greater serum carotenoid levels, and
2. Decreased serum lipid peroxide levels.
The secondary objectives are to determine whether ovarian cancer patients in their first clinical remission who consume the nutritional supplements Juice Plus+ and Juice Plus+ Complete, will have better outcomes than those undergoing dietary counseling alone, on the following measures:
1. Decreased malnutrition, including serum albumin, RBP, weight status, hip,waist, wrist, and mid-arm circumference assessments.
2. The assessment of iron status, using measurements of hemoglobin/hematocrit, blood ferritin levels, blood iron levels, and TIBC.
3. Increased serum vitamin and mineral levels (i.e., tocopherols, B₁₂, magnesium, and zinc).
4. A Quality of life survey. Time of relapse will also be recorded.

Study Status Information



Study Activation / Registration Date:	02/18/2003

IRB Review and Approval Date:	04/18/2001

Study Type:	Therapeutic

Recruitment Status:	Open

Projected Accrual:	Total of 75 patients (25 per arm and 25for an observation group)

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

Unavailable

Exclusion Criteria:

Unavailable

Links

Registration Number: NCT01439659
Study Information on Clinical Trials Registry (clinicaltrials.gov)