Breast CancerNCT00336102
Thyroid Dysfunction in Women With Newly Diagnosed Breast Cancer Compared to Healthy Volunteers
An observational study of Breast Cancer and Fatigue, run by University of South Florida at 41 sites in United States.
Trial summary
RATIONALE: Learning about thyroid dysfunction in patients with breast cancer may help plan treatment and may help patients live more comfortably. PURPOSE: This clinical trial is studying how often thyroid dysfunction happens in women with newly diagnosed stage I, stage II, or stage III breast cancer who are planning… Read more about this study
- Who is it for?
- Ages 20 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Fatigue, Hypothyroidism
- What is being tested?
- physiologic testing, fatigue assessment and management and management of therapy complications
- Type of treatment
- Surgery or procedure
- How many people
- 541 participants
- Where
- 41 sitesUnited States
- Study dates
- Apr 2006to Jun 2015
- 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 20 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: This is a pilot study with a planned accrual of 270 patients (cases) and 280 healthy volunteers (controls). Patients between the ages of 25 and 75, diagnosed with primary, operable, stage I-III B breast cancer with planned chemotherapy regimen Adriamycin / Cytoxan (AC) plus a taxane are trial candidates. Participants will be asked to nominate 2 women to serve as their healthy control. In the event the first woman is not eligible or decides not to participate, the second woman will be evaluated. Controls will be women from the same general demographic area, have no prior history of cancer and be within 5 years of the patient's age (+/- 5 years).
CASE SELECTION:
- CASE INCLUSION CRITERIA:
- Women between the ages of 25 and 75
- Diagnosed with primary and operable Stage I - IIIB breast cancer
- Scheduled to receive neoadjuvant or adjuvant Adriamycin and Cytoxan (AC) plus a taxane (taxane may be given with AC or follow AC)
- No chemotherapy prior to baseline sample collection
- No prior history of other cancers (except non-melanoma skin cancer)
- Preoperative radiation therapy is permitted
- No diagnosis of hypothyroidism or hyperthyroidism.
- CASE EXCLUSION CRITERIA:
- Stage IV breast cancer
- Scheduled to receive neoadjuvant hormonal therapy (patients who will receive adjuvant hormonal therapy may participate)
- Received adjuvant hormonal therapy or chemotherapy prior to sample collection
- On chemotherapeutic regimen other than Adriamycin and Cytoxan plus a taxane.
- Patients receiving monoclonal antibodies or other biologic therapy may not participate
- Patients scheduled to receive Herceptin may not participate
- Diagnosed with hyperthyroidism or hypothyroidism. (Women being treated for hypothyroidism are not eligible)
- Women with a baseline TSH of 10 or higher will not continue on study
- Women who are pregnant or lactating are not eligible. (Women of childbearing potential who are planning to become pregnant within the next 24 months should not enroll in this study)
CONTROL SELECTION:
- CONTROL INCLUSION CRITERIA:
- Cannot be a blood relative of the case. They can be friends, neighbors, women from social activities, local business, doctors' offices, etc.
- Must live near or in the town of the case
- Women between the ages of 20 and 80 (age-matched to cases +/- 5 years)
- No prior history of cancer (except non-melanoma skin cancer)
- Women ages 40 and older should have had a mammogram within 2 years of study entry, showing no evidence of breast cancer.
- The friend control may bring their mammogram report or send a release and have records faxed to the enrolling center.
- Women under the age of 40 should have had a clinical breast examination within 2 years of study entry, showing no need for diagnostic mammography. If a mammogram was required, it should show no evidence of breast cancer.
- The friend control may bring their mammogram / breast exam report or send a release and have records faxed to the enrolling center.
Trial locations and contacts
41 sites in 1 country.
41 sites in 1 country
United States41 sites
Saint Anthony's Hospital at Saint Anthony's Health Center
Alton, Illinois, 62002
AnMed Cancer Center
Anderson, South Carolina, 29621
Mission Hospitals - Memorial Campus
Asheville, North Carolina, 28801
Northeast Georgia Cancer Care, LLC - Medical Oncology
Athens, Georgia, 30607
Medical College of Georgia Cancer Center
Augusta, Georgia, 30912-3500
MBCCOP - Medical College of Georgia Cancer Center
Augusta, Georgia, 30912-4000
MeritCare Bemidji
Bemidji, Minnesota, 56601
Southeast Cancer Center
Cape Girardeau, Missouri, 63701
Saint Francis Medical Center
Cape Girardeau, Missouri, 63703
CCOP - MeritCare Hospital
Fargo, North Dakota, 58122
Roger Maris Cancer Center at MeritCare Hospital
Fargo, North Dakota, 58122
Rutherford Internal Medicine Associates, PA
Forest City, North Carolina, 28043
CCOP - Southeast Cancer Control Consortium
Goldsboro, North Carolina, 27534-9479
Southeastern Medical Oncology Center - Goldsboro
Goldsboro, North Carolina, 27534
North Colorado Medical Center
Greeley, Colorado, 80631-5199
Moses Cone Regional Cancer Center at Wesley Long Community Hospital
Greensboro, North Carolina, 27403-1198
Pardee Memorial Hospital
Hendersonville, North Carolina, 28791
Cancer Centers of Central Florida, PA
Leesburg, Florida, 34788
McKee Medical Center
Loveland, Colorado, 80538
Good Samaritan Regional Health Center
Mount Vernon, Illinois, 62864
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, 70112
Newark Beth Israel Medical Center
Newark, New Jersey, 07112
CCOP - Western Regional, Arizona
Phoenix, Arizona, 85006-2726
CCOP - Beaumont
Royal Oak, Michigan, 48073-6769
William Beaumont Hospital - Royal Oak Campus
Royal Oak, Michigan, 48073
Feist-Weiller Cancer Center at Louisiana State University Health Sciences
Shreveport, Louisiana, 71130-3932
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Spartanburg, South Carolina, 29303
St. John's Regional Health Center
Springfield, Missouri, 65804-2263
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, 65804
Hulston Cancer Center at Cox Medical Center South
Springfield, Missouri, 65807
CCOP - St. Louis-Cape Girardeau
St Louis, Missouri, 63141
David C. Pratt Cancer Center at St. John's Mercy
St Louis, Missouri, 63141
Iredell Memorial Hospital
Statesville, North Carolina, 28687-1828
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
Tampa, Florida, 33612-9497
CCOP - Scott and White Hospital
Temple, Texas, 76508
Scott and White Cancer Institute
Temple, Texas, 76508
MBCCOP - Our Lady of Mercy Comprehensive Cancer Center
The Bronx, New York, 10466
Our Lady of Mercy Medical Center Comprehensive Cancer Center
The Bronx, New York, 10466
William Beaumont Hospital - Troy Campus
Troy, Michigan, 48085
Southeastern Medical Oncology Center - Wilson
Wilson, North Carolina, 27893
Forsyth Regional Cancer Center at Forsyth Medical Center
Winston-Salem, North Carolina, 27103
About this study
Official title: Thyroid Function & Breast Cancer: A Pilot Study to Estimate the Prevalence of Thyroid Dysfunction in Women Diagnosed With Breast Cancer and the Magnitude of Change in Thyroid Function Post-Chemotherapy
RATIONALE: Learning about thyroid dysfunction in patients with breast cancer may help plan treatment and may help patients live more comfortably.
PURPOSE: This clinical trial is studying how often thyroid dysfunction happens in women with newly diagnosed stage I, stage II, or stage III breast cancer who are planning to undergo chemotherapy compared to how often it happens in healthy volunteers.
Read the detailed description
OBJECTIVES:
Primary
- Compare the proportion of hypothyroidism in women with newly diagnosed stage I-IIIB breast cancer (prior to chemotherapy) vs in cancer-free, age-matched healthy volunteers.
- Compare the magnitude of change in thyroid function in these patients from baseline to 24 months vs in cancer-free, age-matched healthy volunteers.
Secondary
- Correlate variation in thyroid function with fatigue symptom scores.
- Correlate variation in thyroid function with anthropometric measurements.
OUTLINE: This is a pilot, multicenter study.
Patients and age-matched healthy volunteers undergo blood collection at baseline and at 12 and 24 months after enrollment. They also undergo anthropometric measurements and complete the Fatigue Symptom Inventory at baseline and at 12 and 24 months after enrollment.
PROJECTED ACCRUAL: A total of 270 patients and 280 healthy volunteers will be accrued for this study.
- Conditions
- Breast Cancer, Fatigue, Hypothyroidism
- Being tested
- physiologic testing, fatigue assessment and management, management of therapy complications
- Keywords
- fatigue, hypothyroidism, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer
- Medical subject headings
- Breast Neoplasms, Fatigue, Hypothyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physiologic testingOther
Also called thyroid function tests
Markers of thyroid function including thyroid stimulating hormone (TSH), Free thyroxine (free T4) and Thyroid peroxidase antibody (TPO Ab). These will be performed at baseline, in 12 months and again 24 months after enrollment. All thyroid function marker assays will be performed by LabCorp.
fatigue assessment and managementProcedure or surgery
Also called FSI, Fatigue Symptoms Inventory
Fatigue Symptoms Inventory (FSI) survey
management of therapy complicationsProcedure or surgery
If baseline testing results suggest hyperthyroidism or hypothyroidism, the enrolling center will give test results to participants for follow-up with their primary healthcare provider. Participants with hypothyroidism, who are not started on thyroid hormone, will continue on study, given the TSH level is below 10. Those with hypothyroidism who have treatment initiated will not continue on study. Participants who develop hypothyroidism during the study will not continue on-study if replacement therapy is initiated or if the TSH level is 10 or higher. Work up the next control nominated by the patient or contact the patient for the name of another control
| Study group | Role | What they receive |
|---|---|---|
| Group 1 Breast Cancer Patient Cases | Patients between the ages of 25 and 75, diagnosed with primary, operable, stage I-III B breast cancer with planned chemotherapy regimen Adriamycin / Cytoxan (AC) plus a taxane are trial candidates.
Will have physiologic testing at baseline to assess thyroid function and fatigue assessment and management inventory. Will follow-up on management of therapy complications for thyroid disorder if one identified or until off study. Receives: Other: physiologic testing; Procedure: fatigue assessment and management; Procedure: management of therapy complications | |
| Group 2 Healthy Controls | Controls will be women from the same general demographic area as Group 1 Cases, have no prior history of cancer and be within 5 years of the Group 1 case's age (+/- 5 years).
Will have physiologic testing at baseline to assess thyroid function and fatigue assessment and management inventory. Will follow-up on management of therapy complications for thyroid disorder if one identified or until off study. Receives: Other: physiologic testing; Procedure: fatigue assessment and management; Procedure: management of therapy complications |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare proportion of hypothyroidism in women with newly diagnosed stage I-IIIB breast cancer prior to chemotherapy vs in age-matched healthy volunteers
Measured: 2 years
Compare change in thyroid function from baseline to 24 months after enrollment
Measured: 2 years
Secondary outcomes (1)
Correlate variation in thyroid function with fatigue symptom scores and anthropometric measurements at baseline and 24 months after enrollment
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2006 (estimated)
- Study startApr 2006
- Primary completionJun 2015
- Study completionJun 2015
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 University of South FloridaThe 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-control
- Time perspective
- Prospective
- Enrolment
- 541 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Nagi B. Kumar, PhD RD FADA, Study chair, H. Lee Moffitt Cancer Center and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00336102
- Sponsor's protocol ID
- SCUSF 0502
- Other IDs
- SCUSF-0502, 5U10CA081920-11
- Status last verified
- Jul 2015
- First submitted
- 8 Jun 2006
- Last updated
- 9 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thyroid Function & Breast Cancer: A Pilot Study to Estimate the Prevalence of Thyroid Dysfunction in Women Diagnosed With Breast Cancer and the Magnitude of Change in Thyroid Function Post-Chemotherapy
- ClinicalTrials.gov ID
- NCT00336102
- Acronym / sponsor ID
- SCUSF 0502
- Conditions
- Breast Cancer, Fatigue, Hypothyroidism
- Keywords
- fatigue, hypothyroidism, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 541 participants (actual)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Apr 2006
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 12 Jun 2006 (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: Learning about thyroid dysfunction in patients with breast cancer may help plan treatment and may help patients live more comfortably.
PURPOSE: This clinical trial is studying how often thyroid dysfunction happens in women with newly diagnosed stage I, stage II, or stage III breast cancer who are planning to undergo chemotherapy compared to how often it happens in healthy volunteers.
Detailed description
OBJECTIVES:
Primary
- Compare the proportion of hypothyroidism in women with newly diagnosed stage I-IIIB breast cancer (prior to chemotherapy) vs in cancer-free, age-matched healthy volunteers.
- Compare the magnitude of change in thyroid function in these patients from baseline to 24 months vs in cancer-free, age-matched healthy volunteers.
Secondary
- Correlate variation in thyroid function with fatigue symptom scores.
- Correlate variation in thyroid function with anthropometric measurements.
OUTLINE: This is a pilot, multicenter study.
Patients and age-matched healthy volunteers undergo blood collection at baseline and at 12 and 24 months after enrollment. They also undergo anthropometric measurements and complete the Fatigue Symptom Inventory at baseline and at 12 and 24 months after enrollment.
PROJECTED ACCRUAL: A total of 270 patients and 280 healthy volunteers will be accrued for this study.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 Breast Cancer Patient Cases | – | Other: physiologic testing, Procedure: fatigue assessment and management, Procedure: management of therapy complicationsPatients between the ages of 25 and 75, diagnosed with primary, operable, stage I-III B breast cancer with planned chemotherapy regimen Adriamycin / Cytoxan (AC) plus a taxane are trial candidates. Will have physiologic testing at baseline to assess thyroid function and fatigue assessment and management inventory. Will follow-up on management of therapy complications for thyroid disorder if one identified or until off study. |
| Group 2 Healthy Controls | – | Other: physiologic testing, Procedure: fatigue assessment and management, Procedure: management of therapy complicationsControls will be women from the same general demographic area as Group 1 Cases, have no prior history of cancer and be within 5 years of the Group 1 case's age (+/- 5 years). Will have physiologic testing at baseline to assess thyroid function and fatigue assessment and management inventory. Will follow-up on management of therapy complications for thyroid disorder if one identified or until off study. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This is a pilot study with a planned accrual of 270 patients (cases) and 280 healthy volunteers (controls). Patients between the ages of 25 and 75, diagnosed with primary, operable, stage I-III B breast cancer with planned chemotherapy regimen Adriamycin / Cytoxan (AC) plus a taxane are trial candidates. Participants will be asked to nominate 2 women to serve as their healthy control. In the event the first woman is not eligible or decides not to participate, the second woman will be evaluated. Controls will be women from the same general demographic area, have no prior history of cancer and be within 5 years of the patient's age (+/- 5 years).
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 |
|---|---|---|
| physiologic testingAlso: thyroid function testsMarkers of thyroid function including thyroid stimulating hormone (TSH), Free thyroxine (free T4) and Thyroid peroxidase antibody (TPO Ab). These will be performed at baseline, in 12 months and again 24 months after enrollment. All thyroid function marker assays will be performed by LabCorp. | Other | Group 1 Breast Cancer Patient Cases, Group 2 Healthy Controls |
| fatigue assessment and managementAlso: FSI, Fatigue Symptoms InventoryFatigue Symptoms Inventory (FSI) survey | Procedure or surgery | Group 1 Breast Cancer Patient Cases, Group 2 Healthy Controls |
| management of therapy complicationsIf baseline testing results suggest hyperthyroidism or hypothyroidism, the enrolling center will give test results to participants for follow-up with their primary healthcare provider. Participants with hypothyroidism, who are not started on thyroid hormone, will continue on study, given the TSH level is below 10. Those with hypothyroidism who have treatment initiated will not continue on study. Participants who develop hypothyroidism during the study will not continue on-study if replacement therapy is initiated or if the TSH level is 10 or higher. Work up the next control nominated by the patient or contact the patient for the name of another control | Procedure or surgery | Group 1 Breast Cancer Patient Cases, Group 2 Healthy Controls |
Primary outcome
Compare proportion of hypothyroidism in women with newly diagnosed stage I-IIIB breast cancer prior to chemotherapy vs in age-matched healthy volunteers
Time frame: 2 years
Compare change in thyroid function from baseline to 24 months after enrollment
Time frame: 2 years
1 secondary outcome
Correlate variation in thyroid function with fatigue symptom scores and anthropometric measurements at baseline and 24 months after enrollment
Time frame: 2 years
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 9 Jul 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.
Nagi B. Kumar, PhD RD FADA study chair
H. Lee Moffitt Cancer Center and Research Institute
41 sites 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 Fatigue, run by University of South Florida at 41 sites 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 9 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites 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?
Compare proportion of hypothyroidism in women with newly diagnosed stage I-IIIB breast cancer prior to chemotherapy vs in age-matched healthy volunteers (time frame: 2 years). The study lists 2 primary outcomes in all. 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 9 Jul 2015.