Pilot Study of Soy-Based Meal Replacement (Almased®) as a Weight Loss Intervention in Patients With Estrogen Receptor/Progesterone Receptor-Negative Stage I-III Breast Cancer in Complete Remission. Note: The information about this trial has not been updated by the sponsor/principal investigator/lead organization. Cancer.gov cannot verify the accuracy of the information.

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Alternate Title

Soy-Based Meal Replacement in Helping Women With Stage I, Stage II, or Stage III Breast Cancer in Complete Remission Lose Weight. Note: The information about this trial has not been updated by the sponsor/principal investigator/lead organization. Cancer.gov cannot verify the accuracy of the information.

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
No phase specifiedBehavioral study, Educational/Counseling/Training, Supportive careClosed21 and overNCICCCWFU-98904


  1. 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.
  2. Assess the patient's ability to adhere to this intervention protocol.
  3. 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).
  4. Measure changes in health-related quality of life.

Entry 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

Prior/Concurrent Therapy:

  • See Disease Characteristics
  • No concurrent medications for weight loss
  • No concurrent treatment for ER/PR-negative disease

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

Expected Enrollment


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


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.

Trial Contact Information

Trial Lead Organizations

Wake Forest University Comprehensive Cancer Center

Mara Vitolins, DrPH, RD, Principal investigator
Ph: 336-716-2886; 800-446-2255
Email: mvitolin@wfubmc.edu

Registry Information

Official TitleUse of a Soy-Based Meal Replacement Weight Loss Intervention for Survivors of ER/PR Negative Breast Cancer
Trial Start Date2005-01-27
Registered in ClinicalTrials.govNCT00343434
Date Submitted to PDQ2006-04-18
Information Last Verified2006-12-03
NCI Grant/Contract NumberCA12197

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.