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

This study is ongoing, but not recruiting participants.

Sponsored by: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00019643
  Purpose

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.


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

Genetics Home Reference related topics:   breast cancer   

MedlinePlus related topics:   Breast Cancer    Cancer    Depression   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Longitudinal, Defined Population, Prospective Study
Official Title:   Prospective Study of Potential Factors Affecting Weight in Breast Cancer Patients Receiving Adjuvant Chemotherapy

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:   August 1999

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.

  Eligibility
Ages Eligible for Study:   18 Years to 80 Years

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

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00019643

Locations
United States, Maryland
Cancer Prevention Studies Branch    
      Bethesda, Maryland, United States, 20892

Sponsors and Collaborators

Investigators
Study Chair:     Noreen Aziz     National Cancer Institute (NCI)    
  More Information


Study ID Numbers:   CDR0000066928, NCI-99-C-0026, NCI-99-C-0020
First Received:   March 2, 2007
Last Updated:   March 2, 2007
ClinicalTrials.gov Identifier:   NCT00019643
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
adult solid tumor  
body system/site cancer  
breast cancer  
cancer  
cancer-related problem/condition  
depression  
depression and suicide  
nutrition  
psychosocial effects/treatment  
quality of life
solid tumor
stage I breast cancer
stage I, II, and IIIA breast cancer
stage II breast cancer
stage III breast cancer
stage IIIA breast cancer
stage IIIB, IV, recurrent, and metastatic breast cancer
stage, breast cancer

Study placed in the following topic categories:
Depression
Skin Diseases
Breast Neoplasms
Suicide
Quality of Life
Weight Gain
Depressive Disorder
Recurrence
Behavioral Symptoms
Body Weight
Mental Disorders
Mood Disorders
Breast Diseases

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on November 30, 2008




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