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

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00019643
First Posted: March 6, 2007
Last Update Posted: March 29, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Institutes of Health Clinical Center (CC)
  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

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Prospective Study of Potential Factors Affecting Weight in Breast Cancer Patients Receiving Adjuvant Chemotherapy

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Enrollment: 26
Study Start Date: August 1999
Study Completion Date: April 2007
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00019643


Locations
United States, Maryland
Cancer Prevention Studies Branch
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Institutes of Health Clinical Center (CC)
Investigators
Study Chair: Noreen Aziz National Cancer Institute (NCI)
  More Information

ClinicalTrials.gov Identifier: NCT00019643     History of Changes
Obsolete Identifiers: NCT00001796
Other Study ID Numbers: 990026
99-C-0026
NCI-99-C-0020
CDR0000066928
First Submitted: March 2, 2007
First Posted: March 6, 2007
Last Update Posted: March 29, 2012
Last Verified: March 2012

Keywords provided by National Institutes of Health Clinical Center (CC):
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

Additional relevant MeSH terms:
Breast Neoplasms
Depression
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Behavioral Symptoms