Factors Affecting Weight Gain in Women Receiving Adjuvant Chemotherapy for Breast Cancer

NCT ID: NCT00019643

Last Updated: 2023-10-31

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 26 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 1999-08-31
• Study Completion Date: 2007-04-30

Brief Summary

RATIONALE: Chemotherapy may affect various factors that can lead to weight gain.

PURPOSE: Clinical trial to evaluate factors that may affect weight gain in women receiving adjuvant chemotherapy for stage I, stage II, or stage IIIA breast cancer.

Detailed Description

OBJECTIVES: I. Evaluate the relative contributions of factors that may lead to weight gain in breast cancer patients receiving adjuvant chemotherapy. Factors examined include: Hormonal and growth factor status (follicle stimulating hormone, total, bound, and free estradiol, androgens, sex hormone binding globulin, thyroid hormones, prolactin, insulin-like growth factors I and II, and plasma leptin) Factors affecting energy intake or expenditure (oral intake, physical activity, and resting metabolic rate) Psychological factors (depression and quality of life) II. Evaluate the effect of chemotherapy on hormonal and growth factor status in these patients.

III. Assess the impact of chemotherapy on bone marrow density in these patients.

PROTOCOL OUTLINE:

Data is collected from women diagnosed with primary breast cancer at 3 points (5 visits): (i) after breast cancer surgery, but before chemotherapy begins (2 visits to NIH day hospital 1 week apart); (ii) 2-3 weeks after chemotherapy has ended (2 visits, 1 week apart); and (iii) 6 months after chemotherapy has ended (1 visit). Tests conducted during these visits include evaluation of blood for hormones, growth factors, and leptin; body composition by DXA; visceral and subcutaneous abdominal adipose tissue by an axial CT scan; and evaluation of resting metabolic rate and daily energy expenditure by a single administration of doubly labeled water at visits "a" and "b" during data collection timepoints 1 and 2. Questionnaires assessing epidemiologic risk factors for breast cancer, dietary intake, physical activity, depression, and quality of life are also administered at the three timepoints.

PROJECTED ACCRUAL:

A total of 140 patients will be accrued for this study within 1-2 years.

Conditions

Depression; Stage I Breast Cancer; Stage IIIA Breast Cancer; Nutrition; Stage II Breast Cancer; Psychosocial Effects/Treatment; Quality of Life

Study Design

• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Histologically proven newly diagnosed stage I, II, or resectable IIIA primary breast cancer Scheduled to receive chemotherapy No distant metastases --Prior/Concurrent Therapy-- Biologic therapy: Not specified Chemotherapy: See Disease Characteristics No concurrent neoadjuvant chemotherapy Endocrine therapy: No concurrent thyroid medication Radiotherapy: No concurrent radiotherapy Surgery: See Disease Characteristics No prior oophorectomy Other: No concurrent alternative medicines alone No concurrent participation in dietary and/or exercise weight loss programs --Patient Characteristics-- Age: 18 to 80 Sex: Female Menopausal status: Premenopausal or postmenopausal Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No physical or mental disability that would preclude completing questionnaires No prior or concurrent diabetes mellitus No prior hypothyroidism or hyperthyroidism

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health Clinical Center (CC)

NIH

Sponsor Role: lead

Principal Investigators

Noreen Aziz

Role: STUDY_CHAIR

National Cancer Institute (NCI)

Locations

Cancer Prevention Studies Branch

Bethesda, Maryland, United States

Countries

United States

Other Identifiers

99-C-0026

Identifier Type: -

Identifier Source: secondary_id

NCI-99-C-0020

Identifier Type: -

Identifier Source: secondary_id

CDR0000066928

Identifier Type: -

Identifier Source: secondary_id

990026

Identifier Type: -

Identifier Source: org_study_id

NCT00001796

Identifier Type: -

Identifier Source: nct_alias