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

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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.

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.

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
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Anderson, South Carolina 29621
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9832 US Highway 441 # 101
Leesburg, Florida 34788
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4117 East Fowler Avenue
Tampa, Florida 33612
(813) 745-4673
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Asheville, North Carolina 28801
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1120 15th Street, BAA-5407
Augusta, Georgia 30912
(706) 721-2505
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1233 34th St NW
Bemidji, Minnesota 56601
(218) 333-5000
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Bronx, NY
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211 Saint Francis Drive
Cape Girardeau, Missouri 63703
573-331-3000
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789 Mt Auburn Rd
Cape Girardeau, Missouri 63703
(573) 519-4725
Southeast Cancer Center SoutheastHEALTH is a far-reaching network of providers and facilities including Southeast Hospital...
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820 4th Street North
Fargo, North Dakota 58122
(701) 234-6292
CCOP - MeritCare Hospital The Sanford Community Cancer Consortium is a "newly" formed CCOP, merging...
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Forest City, North Carolina 28043
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Goldsboro, North Carolina 27534
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Goldsboro, North Carolina 27534
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1801 16th St
Greeley, Colorado 80631
(970) 352-4121
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800 N Justice St
Hendersonville, North Carolina 28791
(828) 696-1000
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2000 N Boise Ave
Loveland, Colorado 80538
(970) 669-4640
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1 Good Samaritan Way
Mount Vernon, Illinois 62864
(618) 242-4600
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533 Bolivar Street, Room 420
New Orleans, Louisiana 70112
(504) 568-3435
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201 Lyons Ave
Newark, New Jersey 07112
(973) 926-7000
Newark Beth Israel Medical Center Newark Beth Israel Medical Center, a regional care, teaching hospital...
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Phoenix, Arizona 85006
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Royal Oak, Michigan 48073
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607 S. New Ballas Road
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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101 E Wood St
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
(417) 269-5257
Hulston Cancer Center at Cox Medical Center South In 1997, the cancer program at CoxHealth...
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1730 E Republic Rd
Springfield, Missouri 65804
(417) 269-4520
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Springfield, Missouri 65804
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St. Louis, Missouri 63141
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557 Brookdale Dr
Statesville, North Carolina 28677
(704) 873-5661
Iredell Memorial Hospital Welcome to Iredell Health System, where you'll receive quality healthcare with personal...
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Temple, Texas 76508
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Temple, Texas 76508
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Wilson, North Carolina 27893
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Winston-Salem, North Carolina 27103
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