Spect Analysis of Cardiac Perfusion Changes After Whole Breast/Chest Wall Radiation Therapy With Active Breathing Coordinator

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Breast Cancer Research Foundation
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00321048
First received: May 1, 2006
Last updated: November 15, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention Phase
Breast Neoplasms
Carcinoma, Ductal
Adenocarcinoma
Device: Active Breathing Coordinator
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Spect Analysis of Cardiac Perfusion Changes After Whole Breast/Chest Wall Radiation Therapy With Active Breathing Coordinator

Resource links provided by NLM:


Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:

Primary Outcome Measures:
  • Test the efficacy of the ABC device in protecting the heart from radiation damage in patients with L breast cancer. [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: June 2006
Estimated Study Completion Date: October 2017
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Active Breathing Coordinator
    A SPECT scan will be used to determine if the active breathing device reduces radiation toxicities.
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00321048

Locations
United States, Maryland
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
Breast Cancer Research Foundation
Investigators
Principal Investigator: Richard Zellars, M.D. Sidney Kimmel Comprehensive Cancer Center- Dept. Radiation Oncology
  More Information

Additional Information:
No publications provided

Responsible Party: Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00321048     History of Changes
Other Study ID Numbers: J0609, NA_00002394
Study First Received: May 1, 2006
Last Updated: November 15, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
breast cancer
SPECT
ABC device
Invasive adenocarcinoma of the left breast
Ductal Carcinoma In Situ of the left breast

Additional relevant MeSH terms:
Adenocarcinoma
Breast Neoplasms
Neoplasms
Carcinoma
Carcinoma, Ductal
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms by Site
Breast Diseases
Skin Diseases
Neoplasms, Ductal, Lobular, and Medullary

ClinicalTrials.gov processed this record on April 17, 2014