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Home > "A" Clinical Trials Conditions > A Prospective Study to Evaluate Potential Factors Affecting Weight Among Breast Cancer Patients Receiving Adjuvant Chemotherapy  A Prospective Study to Evaluate Potential Factors Affecting Weight Among Breast Cancer Patients Receiving Adjuvant Chemotherapy
A Prospective Study to Evaluate Potential Factors Affecting Weight Among Breast Cancer Patients Receiving Adjuvant Chemotherapy
For Condition: Breast Neoplasm,Weight Gain
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: 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.
Details: 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:
Study Type: Observational, Natural History
Minimum Age/Maximum Age: /
Genders: Female
Protocol Entry 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.
Total Enrollment: 140
Location and Contact Information:
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 990026; 99-C-0026
Study Start Date: January 25, 1999
Record last reviewed: December 15, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001796
Other Weight Gain Studies:
1. Establishment of Normal Breast Epithelial Cell Lines from Patients at High Risk for Breast Cancer
2. Autologous T-Cell Transplantation and the Immunotherapy of Residual Disease in Breast Cancer: Pilot Study of Vaccine-Driven T-Cell Expansion in Patients Treated with Dose-Intensive Chemotherapy
3. Primary Chemotherapy with Docetaxel-Capecitabine and Doxorubicin-Cyclophosphamide in Breast Cancer
4. A Prospective Study to Evaluate Potential Factors Affecting Weight Among Breast Cancer Patients Receiving Adjuvant Chemotherapy
5. A Phase II Trial of Raloxifene in Pre-Menopausal Women at High Risk for Developing Invasive Breast Cancer
Related Studies:
Other Weight Gain Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
A Prospective Study to Evaluate Potential Factors Affecting Weight Among Breast Cancer Patients Receiving Adjuvant Chemotherapy
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