Thyroid Dysfunction in Women With Newly Diagnosed Breast Cancer Compared to Healthy Volunteers
Status: | Completed |
---|---|
Conditions: | Breast Cancer, Cancer, Other Indications, Endocrine |
Therapuetic Areas: | Endocrinology, Oncology, Other |
Healthy: | No |
Age Range: | 20 - 80 |
Updated: | 4/21/2016 |
Start Date: | April 2006 |
End Date: | June 2015 |
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.
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.
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.
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.
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.
We found this trial at
41
sites
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4117 East Fowler Avenue
Tampa, Florida 33612
Tampa, Florida 33612
(813) 745-4673
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida Moffitt Cancer...
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1120 15th Street, BAA-5407
Augusta, Georgia 30912
Augusta, Georgia 30912
(706) 721-2505
MBCCOP - Medical College of Georgia Cancer Center The Georgia Regents University (GRU) is located...
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MeritCare Bemidji Sanford Health is an integrated health system headquartered in the Dakotas and is...
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Saint Francis Medical Center Saint Francis Medical Center is a 282-bed facility serving more than...
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Southeast Cancer Center SoutheastHEALTH is a far-reaching network of providers and facilities including Southeast Hospital...
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CCOP - MeritCare Hospital The Sanford Community Cancer Consortium is a "newly" formed CCOP, merging...
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North Colorado Medical Center NCMC is a fully accredited, private, non-profit facility licensed to operate...
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Greensboro, North Carolina 27403
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Pardee Memorial Hospital Pardee Hospital is a not-for-profit community hospital founded in 1953 and is...
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McKee Medical Center Through the years, McKee has led the way in health care innovation....
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1 Good Samaritan Way
Mount Vernon, Illinois 62864
Mount Vernon, Illinois 62864
(618) 242-4600
Good Samaritan Regional Health Center St. Mary's Good Samaritan, Incorporated (SMGSI) was created in 1996...
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533 Bolivar Street, Room 420
New Orleans, Louisiana 70112
New Orleans, Louisiana 70112
(504) 568-3435
MBCCOP - LSU Health Sciences Center Established in 1990, the Stanley S. Scott Cancer Center...
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Newark Beth Israel Medical Center Newark Beth Israel Medical Center, a regional care, teaching hospital...
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607 S. New Ballas Road
Saint Louis, Missouri 63141
Saint Louis, Missouri 63141
(314) 251-4800
David C. Pratt Cancer Center at St. John's Mercy Many forms of cancer are more...
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Shreveport, Louisiana 71130
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101 E Wood St
Spartanburg, South Carolina 29303
Spartanburg, South Carolina 29303
(864) 560-6000
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center Gibbs Cancer Center is a nationally...
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3850 S National Ave
Springfield, Missouri 65807
Springfield, Missouri 65807
(417) 269-5257
Hulston Cancer Center at Cox Medical Center South In 1997, the cancer program at CoxHealth...
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CCOP - Cancer Research for the Ozarks Cancer Research for the Ozarks (CRO), also known...
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Iredell Memorial Hospital Welcome to Iredell Health System, where you'll receive quality healthcare with personal...
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