Tamoxifen in the Prevention of Breast Cancer in Hodgkin's Disease Survivors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-04-30

Study Completion Date

2009-06-30

Brief Summary

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The purpose of this study is determine whether or not tamoxifen reduces the chance of Hodgkin's Disease survivors developing breast cancer.

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Detailed Description

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* Patients will receive tamoxifen orally once daily to be taken at home for 1 year. They will be asked to complete a daily drug log to keep track of the pills taken or missed.
* Patients will also be asked to give a blood/DNA sample which will be stored for possible further testing for the presence of cancer related genes that are known nor or discovered in the future.
* Patients will also receive a mammogram that will be reviewed by study officials.
* Side effects will be monitored every 2 months for one year, between visits to the clinic.
* A follow-up visit will be conducted at the 6 month mark and includes a physical exam, blood work, health and wellness surveys)
* A follow-up visit will be performed at the 1 year mark and includes a mammogram, gynecological exam, physical exam, blood work, health and wellness surveys.
* Patients active participation will be for 1 year. However, tamoxifen has been shown to be effective after a 5-year course in other women at increased risk for breast cancer, the patient may decide to stay on tamoxifen for 4 additional years.

Conditions

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Hodgkin's Disease Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Tamoxifen

Single arm: Tamoxifen 20mg daily

Group Type EXPERIMENTAL

Tamoxifen

Intervention Type DRUG

Given orally, daily for one year.

Interventions

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Tamoxifen

Given orally, daily for one year.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Females diagnosed with Hodgkin's Disease at age \< 35 years
* \> 5 years from mantle or chest radiation
* Current age \> 30 years
* Has completed childbearing
* Willingness to discontinue use of oral contraceptives or other hormonal contraception for duration of the study

Exclusion Criteria

* History of secondary malignancy after Hodgkin's disease, except thyroid cancer of basal cell cancer
* Recurrence of Hodgkin's disease in the 5 years before study entry
* Current participation in any other cancer prevention study
* Current or prior use of tamoxifen
* Current use of coumadin
* History of deep venous thrombosis, pulmonary embolism, or a condition known to be associated with hypercoagulability
* History of cerebrovascular accident
* History of macular degeneration
* Current use of chemotherapy for benign disease

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No