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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


N/A
20 Years
80 Years
Open (Enrolling)
Female
Breast Cancer, Fatigue, Hypothyroidism

Thank you

Trial Information

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


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.

Inclusion Criteria


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.

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Prospective

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

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Nagi B. Kumar, PhD RD FADA

Investigator Role:

Study Chair

Investigator Affiliation:

H. Lee Moffitt Cancer Center and Research Institute

Authority:

United States: Data and Safety Monitoring Board

Study ID:

SCUSF 0502

NCT ID:

NCT00336102

Start Date:

April 2006

Completion Date:

Related Keywords:

  • Breast Cancer
  • Fatigue
  • Hypothyroidism
  • fatigue
  • hypothyroidism
  • stage I breast cancer
  • stage II breast cancer
  • stage IIIA breast cancer
  • stage IIIB breast cancer
  • Breast Neoplasms
  • Fatigue
  • Hypothyroidism
  • Thyroid Diseases

Name

Location

CCOP - Southeast Cancer Control ConsortiumWinston-Salem, North Carolina  27104-4241
MeritCare BemidjiBemidji, Minnesota  56601
CCOP - MeritCare HospitalFargo, North Dakota  58122
CCOP - Cancer Research for the OzarksSpringfield, Missouri  65807
Newark Beth Israel Medical CenterNewark, New Jersey  07112
CCOP - Western Regional, ArizonaPhoenix, Arizona  85006-2726
CCOP - Scott and White HospitalTemple, Texas  76508
MBCCOP - LSU Health Sciences CenterNew Orleans, Louisiana  70112
CCOP - St. Louis-Cape GirardeauSaint Louis, Missouri  63141
CCOP - BeaumontRoyal Oak, Michigan  48073-6769
Hulston Cancer Center at Cox Medical Center SouthSpringfield, Missouri  65807
St. John's Regional Health CenterSpringfield, Missouri  65804
Mission Hospitals - Memorial CampusAsheville, North Carolina  28801
Our Lady of Mercy Medical Center Comprehensive Cancer CenterBronx, New York  10466
North Colorado Medical CenterGreeley, Colorado  80631
McKee Medical CenterLoveland, Colorado  80539
Saint Anthony's Hospital at Saint Anthony's Health CenterAlton, Illinois  62002
Good Samaritan Regional Health CenterMt. Vernon, Illinois  62864
William Beaumont Hospital - Royal Oak CampusRoyal Oak, Michigan  48073
David C. Pratt Cancer Center at St. John's MercySt. Louis, Missouri  63141
MBCCOP - Medical College of Georgia Cancer CenterAugusta, Georgia  30912-3730
Feist-Weiller Cancer Center at Louisiana State University Health SciencesShreveport, Louisiana  71130-3932
Saint Francis Medical CenterCape Girardeau, Missouri  63701
Iredell Memorial HospitalStatesville, North Carolina  28677
Forsyth Regional Cancer Center at Forsyth Medical CenterWinston-Salem, North Carolina  27103
H. Lee Moffitt Cancer Center and Research Institute at University of South FloridaTampa, Florida  33612
Moses Cone Regional Cancer Center at Wesley Long Community HospitalGreensboro, North Carolina  27401
Pardee Memorial HospitalHendersonville, North Carolina  28791
Gibbs Regional Cancer Center at Spartanburg Regional Medical CenterSpartanburg, South Carolina  29303
AnMed Cancer CenterAnderson, South Carolina  29621
William Beaumont Hospital - Troy CampusTroy, Michigan  48085
Southeastern Medical Oncology Center - GoldsboroGoldsboro, North Carolina  27534
Southeast Cancer CenterCape Girardeau, Missouri  63703
Roger Maris Cancer Center at MeritCare HospitalFargo, North Dakota  58122
Northeast Georgia Cancer Care, LLC - Medical OncologyAthens, Georgia  30607
Scott and White Cancer InstituteTemple, Texas  76508
Cancer Centers of Central Florida, PALeesburg, Florida  34788
Medical College of Georgia Cancer CenterAugusta, Georgia  30912-3500
MBCCOP - Our Lady of Mercy Comprehensive Cancer CenterBronx, New York  10466
Rutherford Internal Medicine Associates, PAForest City, North Carolina  28043
Southeastern Medical Oncology Center - WilsonWilson, North Carolina  27893