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

NCT00343434 | Completed

• 2 other identifiers: CCCWFU-98904CDR0000481274
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer; Obesity

Keywords

stage I breast cancer; stage II breast cancer; stage IIIA breast cancer; stage IIIB breast cancer; stage IIIC breast cancer; obesity

Interventions

behavioral dietary intervention BEHAVIORAL

exercise intervention BEHAVIORAL

soy isoflavones DIETARY_SUPPLEMENT

soy protein isolate DIETARY_SUPPLEMENT

counseling intervention OTHER

educational intervention OTHER

psychosocial assessment and care PROCEDURE

quality-of-life assessment PROCEDURE

Eligibility Criteria

• Age: 21 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157-1096, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Obesity

Interventions

Soybean Proteins; Counseling; Early Intervention, Educational; Psychiatric Rehabilitation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Plant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Plant Proteins, Dietary; Dietary Proteins; Food; Diet, Food, and Nutrition; Physiological Phenomena; Soy Foods; Vegetable Products; Vegetables; Food and Beverages; Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Child Health Services; Preventive Health Services; Rehabilitation; Therapeutics

Study Officials

• Mara Vitolins, DrPH, RD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Purpose: SUPPORTIVE CARE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2006
• First Posted: June 23, 2006
• Study Start: January 1, 2005
• Primary Completion: July 1, 2007
• Last Updated: January 19, 2017

Record last verified: 2013-06

Locations

US (1)