Protocol Number: 99-C-0026

Title:

A Prospective Study to Evaluate Potential Factors Affecting Weight Among Breast Cancer Patients Receiving Adjuvant Chemotherapy

Number:

99-C-0026

Summary:

An estimated 178,700 new cases of invasive breast cancer will be diagnosed in 1998, most with early stage disease requiring adjuvant chemotherapy. Significant weight gain is consistently reported among 50 to 96% of breast cancer patients who have received systemic adjuvant chemotherapy, the average weight increase ranging from 3 to 6 kg in these studies. Weight gain in breast cancer patients post-diagnosis and treatment is associated with decreased disease-free and overall survival, as well as poor quality of life. Mechanisms underlying this weight gain have not been delineated or studied.

The primary objective of this investigation is to evaluate factors that may lead to weight gain among women with breast cancer who are treated with adjuvant chemotherapy, in order to assess and elucidate underlying physiologic mechanism(s). Plausible mechanisms that will be evaluated include alterations in: (a) hormonal and growth factor status, including ovarian/gonadotrophic hormones such as total, bound, and free estradiol, androgens, sex hormone binding globulin (SHBG), follicle stimulating hormone (FSH), thyroid hormones, prolactin, insulin-like growth factors I and II (IGF I and II), and plasma leptin; (b) factors affecting energy intake or expenditure including oral intake, physical activity, and resting metabolic rate, and (c) psychological factors such as depression and quality of life.

We will conduct a prospective study of approximately 140 women (including pre- and post-menopausal patients) with newly diagnosed, stage I, II, and IIIA, primary breast cancer, who will undergo adjuvant chemotherapy with currently utilized stage appropriate chemotherapeutic regimens. Body weight, body composition by dual energy X-ray absorptiometry (DXA), and the mechanistic factors described above will be measured at 3 time points, (a) baseline (prior to the first cycle or dose of adjuvant chemotherapy); (b) 2 weeks after the final administration of adjuvant chemotherapy; and (c) 6 months after the final administration of adjuvant chemotherapy. Total energy expenditure will also be measured by the doubly-labeled water (DLW) method at the first and second time-points. Data will be collected for other factors that may affect weight gain including the particular chemotherapeutic regimen, number of cytotoxic agents in the regimen, route of delivery, menopausal and nodal status, and baseline weight. Statistical analysis of the factors postulated as predictive of weight gain will involve paired t-tests, analysis of variance (ANOVA), and multivariate regression techniques. We believe that chemotherapy may induce significant changes in the hormonal milieu or growth factor status, leptin, energy intake or expenditure, and/or body composition among women who do gain weight during adjuvant chemotherapy or post treatment. Information obtained from this study will provide the insight and rationale needed for logical and optimal interventions to curb weight gain in breast cancer patients.

Sponsoring Institute:

National Cancer Institute (NCI)

Recruitment Detail

Type: Follow-up Of Previously Enrolled Subjects Only

Gender: Female

Referral Letter Required: No

Population Exclusion(s): Male

Eligibility Criteria: This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Special Instructions: Currently Not Provided

Disease Category:

PROTICD

Keywords:

Energy Expenditure

Body Composition

Hormones

Physical Activity

Dietary Intake

Recruitment Keywords:

None

Conditions:

Breast Neoplasm

Weight Gain

Investigational Drug(s):

None

Investigational Device(s):

None

Contacts:

This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Citations:

Demark-Wahnefried W, Peterson BL, Winer EP, Marks L, Aziz N, Marcom PK, Blackwell K, Rimer BK. Changes in weight, body composition, and factors influencing energy balance among premenopausal breast cancer patients receiving adjuvant chemotherapy. J Clin Oncol. 2001 May 1;19(9):2381-9. PMID: 11331316

Landis SH, Murray T, Bolden S, Wingo PA. Cancer statistics, 1998. CA Cancer J Clin. 1998 Jan-Feb;48(1):6-29. Erratum in: CA Cancer J Clin 1998 May-Jun;48(3):192. CA Cancer J Clin 1998 Nov-Dec;48(6):329. PMID: 9449931

Stoll BA. Diet and exercise regimens to improve breast carcinoma prognosis. Cancer. 1996 Dec 15;78(12):2465-70.

PMID: 8952552

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
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