Soy-Based Meal Replacement in Helping Women With Stage I, Stage II, or Stage III Breast Cancer in Complete Remission Lose Weight

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier:
NCT00343434
First received: June 22, 2006
Last updated: June 4, 2013
Last verified: June 2013
  Purpose

RATIONALE: A diet using a soy-based meal replacement may help survivors of breast cancer lose weight and improve their quality of life.

PURPOSE: This clinical trial is studying how well a soy-based meal replacement works in helping women with stage I, stage II, or stage III breast cancer in complete remission lose weight.


Condition Intervention
Breast Cancer
Obesity
Behavioral: behavioral dietary intervention
Behavioral: exercise intervention
Dietary Supplement: soy isoflavones
Dietary Supplement: soy protein isolate
Other: counseling intervention
Other: educational intervention
Procedure: psychosocial assessment and care
Procedure: quality-of-life assessment

Study Type: Interventional
Study Design: Primary Purpose: Supportive Care
Official Title: Use of a Soy-Based Meal Replacement Weight Loss Intervention for Survivors of ER/PR Negative Breast Cancer

Resource links provided by NLM:


Further study details as provided by Comprehensive Cancer Center of Wake Forest University:

Estimated Enrollment: 25
Study Start Date: January 2005
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Determine the ability to recruit survivors of estrogen receptor/progesterone receptor (ER/PR)-negative stage I-III breast cancer to participate in a 3-month, soy-based, meal-replacement (Almased®) weight loss intervention.
  • Assess the patient's ability to adhere to this intervention protocol.
  • Measure changes in anthropometrics (body weight, bioelectrical impedance, waist circumference) and biomarkers (serum levels of glucose, insulin, highly specific C-reactive protein, insulin-like growth factor, insulin-like growth factor binding protein-3, lipids).
  • Measure changes in health-related quality of life.

OUTLINE: This is a prospective, longitudinal, pilot study.

Patients undergo goal-oriented, cognitive-behavioral therapy comprising group counseling weekly for 3 weeks and individual counseling once a month. Weight loss interventions include behavioral techniques, dietary modification (using a portion-controlled diet and soy-based meal-replacement [Almased®] once or twice daily), physical activity (≥ 15 minutes per day, 6 days a week), and social support. Weight loss is monitored weekly and patients complete daily logs of dietary intake and physical activity. Therapy continues for 12 weeks.

Health-related quality of life is assessed at baseline and then weekly for 12 weeks.

Patients undergo blood draws at baseline and at 12 weeks for analysis of C-reactive protein, glucose, insulin, insulin-like growth factor (ILGF), and ILGF-binding protein-3.

PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Previously diagnosed stage I-III breast cancer currently in complete remission
  • Completed treatment for breast cancer ≥ 6 months ago

    • Free of disease at last clinic visit
  • Body mass index ≥ 27
  • Hormone receptor status

    • Estrogen receptor (ER)/progesterone receptor (PR) negative

PATIENT CHARACTERISTICS:

  • Female
  • Menopausal status not specified
  • No history of soy allergies
  • No uncontrolled blood pressure
  • No uncontrolled hyperthyroidism or hypothyroidism
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No diabetes mellitus (type 1 or 2)
  • No medical, psychiatric, or behavioral factors that would preclude study participation
  • No definite plans to move out of the area during the study period

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No concurrent medications for weight loss
  • No concurrent treatment for ER/PR-negative disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00343434

Locations
United States, North Carolina
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157-1096
Sponsors and Collaborators
Comprehensive Cancer Center of Wake Forest University
Investigators
Principal Investigator: Mara Vitolins, DrPH, RD Comprehensive Cancer Center of Wake Forest University
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00343434     History of Changes
Other Study ID Numbers: CCCWFU-98904, CDR0000481274
Study First Received: June 22, 2006
Last Updated: June 4, 2013
Health Authority: United States: Federal Government

Keywords provided by Comprehensive Cancer Center of Wake Forest University:
stage I breast cancer
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
obesity

Additional relevant MeSH terms:
Breast Neoplasms
Obesity
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 23, 2014