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

This study is no longer recruiting patients.

Sponsored by: National Cancer Institute (NCI)
Information provided by: Warren G Magnuson Clinical Center (CC)

Purpose

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.

Condition
Breast Neoplasm
Weight Gain

MedlinePlus related topics:  Breast Cancer
Genetics Home Reference related topics:  breast cancer

Study Type: Observational
Study Design: Natural History

Further Study Details: 

Expected Total Enrollment:  140

Study start: January 25, 1999

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.

Eligibility

Genders Eligible for Study:  Female

Criteria

INCLUSION CRITERIA
Histologically confirmed diagnosis of primary breast cancer, stages I, II, and operable IIIA, who will receive chemotherapy per all currently utilized stage appropriate regimens.
Breast cancer patients who have yet to commence chemotherapy at the Clinical Center NIH, National Naval Hospital, or Walter Reed Army Medical Center, will be identified and invited to participate in the study beginning in September to October 1998.
Women between the ages of 18 and 80 years.
Premenopausal women (date of last menstrual period less than one year prior to baseline evaluation, FSH levels less than or equal to 10 IU/mL, no history of natural menopause or hysterectomy with oophorectomy).
Postmenopausal women (no periods for greater than 1 year, elevated serum FSH greater than or equal to 10 IU/mL; natural menopause or hysterectomy without oophorectomy).
Note: FSH levels will be drawn on all women electing to participate in this study.
EXCLUSION CRITERIA
Patients whose current physical or mental abilities prevent them from completing the questionnaires are not eligible.
Breast cancer patients who will not be receiving chemotherapy are not eligible.
Breast cancer patients receiving concurrent radiation therapy or neo-adjuvant chemotherapy are not eligible.
Patients receiving alternative medicines alone are not eligible.
Patients with recurrent breast cancer are not eligible.
Breast cancer patients in stages IIIB and above, or patients with distant metastases.
Women participating in, or planning to participate in dietary and/or exercise weight loss
Breast cancer patients with a previous or concurrent history of diabetes mellitus are not eligible.
Patients reporting prior history of hypo or hyperthyroidism and/or currently receiving medication for thyroid disorders are not eligible.

Location Information


Maryland
      National Cancer Institute (NCI), 9000 Rockville Pike,  Bethesda,  Maryland,  20892,  United States

More Information

Detailed Web Page

Publications

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.

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.

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

Study ID Numbers:  990026; 99-C-0026
Record last reviewed:  December 20, 2004
Last Updated:  January 12, 2005
Record first received:  November 3, 1999
ClinicalTrials.gov Identifier:  NCT00001796
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005