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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:
ClinicalTrials.gov Identifier:
NCT00343434
First Posted: June 23, 2006
Last Update Posted: January 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences
  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 Wake Forest University Health Sciences:

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

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00343434


Locations
United States, North Carolina
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157-1096
Sponsors and Collaborators
Wake Forest University Health Sciences
National Cancer Institute (NCI)
Investigators
Principal Investigator: Mara Vitolins, DrPH, RD Wake Forest University Health Sciences
  More Information

Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT00343434     History of Changes
Other Study ID Numbers: CCCWFU-98904
CDR0000481274 ( Registry Identifier: PDQ (Physician Data Query) )
First Submitted: June 22, 2006
First Posted: June 23, 2006
Last Update Posted: January 19, 2017
Last Verified: June 2013

Keywords provided by Wake Forest University Health Sciences:
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
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases