Breast CancerNCT00666913
Menopausal Symptoms in Women With Breast Cancer or At High Risk of Breast Cancer Treated on Another Clinical Trial
An observational study of Breast Cancer and Hot Flashes, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Hot Flashes
- What is being tested?
- informational intervention
- How many people
- 183 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Jun 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Data from an archived database of a closed clinical trial is retrieved.
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
Trial locations and contacts
1 site in 1 country.
United States1 site
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106
About this study
Official title: Menopausal Symptoms in Women With Breast Cancer
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.
Read the 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.
- Conditions
- Breast Cancer, Hot Flashes
- Being tested
- informational intervention
- Keywords
- 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
- Medical subject headings
- Breast Neoplasms, Hot Flashes, Breast Carcinoma In Situ
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
informational interventionOther
Data from an archived database of a closed clinical trial is retrieved.
What is being measured
The primary outcome is the main question the study is designed to answer.
Retrieval and analysis of data regarding the frequency and intensity of hot flashes
Data from an archived database of a closed clinical trial is retrieved.
Measured: Up to one year
Secondary outcomes (1)
Assessment of psychosocial and quality of life scales (i.e., FACT-B and POMS)
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.
Measured: Up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2008 (estimated)
- Study startOct 2007
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 183 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Lois C. Friedman, PhD, Principal investigator, Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00666913
- Sponsor's protocol ID
- CASE3107
- Other IDs
- P30CA043703, CASE3107
- Status last verified
- Sep 2015
- First submitted
- 24 Apr 2008
- Last updated
- 29 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Menopausal Symptoms in Women With Breast Cancer
- ClinicalTrials.gov ID
- NCT00666913
- Acronym / sponsor ID
- CASE3107
- Conditions
- Breast Cancer, Hot Flashes
- Keywords
- 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 type
- Observational
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Oct 2007
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 25 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Data from an archived database of a closed clinical trial is retrieved.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| informational interventionData from an archived database of a closed clinical trial is retrieved. | Other | – |
Primary outcome
Retrieval and analysis of data regarding the frequency and intensity of hot flashes
Time frame: Up to one year
Data from an archived database of a closed clinical trial is retrieved.
1 secondary outcome
Assessment of psychosocial and quality of life scales (i.e., FACT-B and POMS)
Time frame: Up to one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lois C. Friedman, PhD principal investigator
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Hot Flashes, run by Case Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retrieval and analysis of data regarding the frequency and intensity of hot flashes (time frame: Up to one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2015.