Menopausal Symptoms in Women With Breast Cancer or At High Risk of Breast Cancer Treated on Another Clinical Trial - Full Text View

Sponsors and Collaborators:	Case Comprehensive Cancer Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00666913

Purpose

RATIONALE: Gathering information about the frequency and intensity of hot flashes in patients with breast cancer and in patients who have a high risk of developing breast cancer may help doctors learn more about menopausal symptoms.

PURPOSE: This clinical trial is looking at menopausal symptoms in women with breast cancer or at high risk of breast cancer who received treatment on another clinical trial.

Condition	Intervention
Breast Cancer Cancer-Related Problem/Condition	Procedure: informational intervention

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Menopause

U.S. FDA Resources

Study Type:	Observational
Official Title:	Menopausal Symptoms in Women With Breast Cancer

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

Primary Outcome Measures:

Retrieval and analysis of data regarding the frequency and intensity of hot flashes [ Designated as safety issue: No ]

Secondary Outcome Measures:

Assessment of psychosocial and quality of life scales (i.e., FACT-B and POMS) [ Designated as safety issue: No ]

Estimated Enrollment:	62
Study Start Date:	October 2007
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Retrieve data from an archived database of a closed clinical trial that involved treatment with sertraline hydrochloride or a placebo for the management of hot flashes or other menopausal symptoms in women with breast cancer or at high risk of breast cancer.
Analyze the results of this closed clinical trial so that they can be published.

OUTLINE: Data from an archived database of a closed clinical trial is retrieved. Descriptive analyses of outcome variables (e.g., menopausal symptoms, including number and intensity of hot flashes, and psychosocial and quality of life scales) are conducted to gain insight into their distributional aspects. Data is analyzed using ANOVA with repeated measures to account for the changes within a patient over time as a function of treatment assignment. Summary scores from the psychosocial scales that are reasonably complete (i.e., FACT-B and POMS) are examined using mixed linear models to account for patient-specific differences, treatment effects, and variable patterns of completeness.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Personal or family history of carcinoma in situ of the breast or invasive breast cancer
Treated with sertraline hydrochloride or a placebo on a clinical trial (that is now closed) at the Baylor College of Medicine-The Methodist Hospital Breast Cancer Center
Reported hot flashes with a hot flash rating of > 15 (frequency and severity) for 1 week (before starting treatment with sertraline hydrochloride or a placebo)
No progressive metastatic breast cancer
Hormone receptor status not specified

PATIENT CHARACTERISTICS:

Female
Menopausal status not specified

PRIOR CONCURRENT THERAPY:

See Disease Characteristics

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00666913

Sponsors and Collaborators

Case Comprehensive Cancer Center

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Lois C. Friedman, PhD

Case Comprehensive Cancer Center

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000583277, CASE-3107
Study First Received:	April 24, 2008
Last Updated:	October 18, 2008
ClinicalTrials.gov Identifier:	NCT00666913
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

breast cancer in situ
stage I breast cancer
stage II breast cancer
stage IIIA breast cancer

stage IIIB breast cancer
stage IIIC breast cancer
hot flashes

Study placed in the following topic categories:

Skin Diseases
Hot Flashes
Breast Neoplasms
Menopause
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009