Overview

This trial is active, not recruiting.

Conditions breast neoplasms, carcinoma, ductal, adenocarcinoma
Treatment active breathing coordinator
Phase phase 3
Sponsor Sidney Kimmel Comprehensive Cancer Center
Collaborator Breast Cancer Research Foundation
Start date June 2006
End date January 2010
Trial size 50 participants
Trial identifier NCT00321048, J0609, NA_00002394

Summary

Cardiac perfusion changes have been seen after whole breast / chest wall irradiation for breast cancer. The Active Breathing Coordinator (ABC) device theoretically decreases radiation exposure to the heart during radiation for breast cancer. In this trial cardiac perfusion changes or lack thereof will be quantified in women treated with radiation for breast cancer while using the ABC device. The control group of the study will consist of patients randomized to radiation therapy without the ABC device.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose diagnostic
Arm
(Experimental)
Patients will receive radiation therapy at a dose of 180-200 cGy per fraction for 23-27 fractions to a total dose of 4600 - 4860 cGy. Additional radiation to the lumpectomy bed or mastectomy scar is at the discretion of the treating physician. The total dose to the tumor bed or mastectomy scar cannot exceed 6600cGy. Treatments will be given Monday through Friday.
active breathing coordinator
A SPECT scan will be used to determine if the active breathing device reduces radiation toxicities.

Primary Outcomes

Measure
Test the efficacy of the ABC device in protecting the heart from radiation damage in patients with L breast cancer.
time frame: 5 years

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria: - Patient must be 18 and older - Patients must have histologically confirmed (by routine H&E staining) invasive adenocarcinoma or Ductal Carcinoma In Situ of the left breast. - Patients must have undergone a segmental mastectomy (SM) or Mastectomy - Patients must not have received prior radiation therapy to the breast at any time for any reason. - Any patient with active local-regional disease prior to registration is not eligible. - Patients must not be pregnant due to the potential for fetal harm as a result of this treatment regimen. Women of child-bearing age will be given a serum pregnancy test prior to study entry to ensure they are not pregnant. Women of child-bearing potential must use effective non-hormonal contraception while undergoing radiation therapy. - Patients must not have a serious medical or psychiatric illness which prevents informed consent or compliance with treatment. - All patients must be informed of the investigational nature of this study and give written informed consent in accordance with institutional and federal guidelines. Exclusion Criteria: - Patients requiring oxygen - Sarcoma or Squamous Cell pathology - Right-sided breast cancers - Metastatic disease to the breast

Additional Information

Official title Spect Analysis of Cardiac Perfusion Changes After Whole Breast/Chest Wall Radiation Therapy With Active Breathing Coordinator
Principal investigator Richard Zellars, M.D.
Description 50 left sided breast cancer patients will be randomized to receive breast/chest wall irradiation with or without ABC. Patients will receive radiation therapy at a dose of 180-200 cGy per fraction for 23-27 fractions to a total dose of 4600 - 4860 cGy. Additional radiation to the lumpectomy bed or mastectomy scar is at the discretion of the treating physician. The total dose to the tumor bed or mastectomy scar cannot exceed 6600cGy. Treatments will be given Monday through Friday. After the completion of radiation therapy, patients will be seen on the following schedule: A follow up examination will take place every 3-6 months for the first two years, then every 4-6 months for years for the next 3 years. After 5 years follow-up evaluations will occur annually. A SPECT scan will be obtained at 6 months post therapy. Patients must be 18 and older and must have histologically confirmed (by routine H&E staining) invasive adenocarcinoma or Ductal Carcinoma In Situ of the left breast. Patients must have also undergone a segmental mastectomy (SM) or Mastectomy. Patients must not have received prior radiation therapy to the breast at any time for any reason. Patients must not be pregnant due to the potential for fetal harm as a result of this treatment regimen.
Trial information was received from ClinicalTrials.gov and was last updated in November 2014.
Information provided to ClinicalTrials.gov by Sidney Kimmel Comprehensive Cancer Center.