Spect Analysis of Cardiac Perfusion Changes After Whole Breast/Chest Wall Radiation Therapy With ABC

Breast Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00321048
• Other study ID #: J0609
• Secondary ID: NA_00002394
• Status: Completed
• Phase: N/A
• Start date: June 2006
• Est. completion date: January 2010

Study information

• Verified date: May 2019
• Source: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Breast Neoplasms
• Carcinoma, Ductal

Intervention

Device:
• Active Breathing Coordinator
A SPECT scan will be used to determine if the active breathing device reduces radiation toxicities.

Locations

Country	Name	City	State
United States	The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Breast Cancer Research Foundation

Country where clinical trial is conducted

United States, 

References & Publications (1)

Zellars R, Bravo PE, Tryggestad E, Hopfer K, Myers L, Tahari A, Asrari F, Ziessman H, Garrett-Mayer E. SPECT analysis of cardiac perfusion changes after whole-breast/chest wall radiation therapy with or without active breathing coordinator: results of a r — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of Active Breathing Coordinator (ABC) Device as Determined by the Mean Apical Perfusion Score	Efficacy of the ABC device in protecting the heart from radiation (XRT) damage in patients with L breast cancer is determined by the change in cardiac perfusion (mean apical perfusion score) as measured by SPECT between baseline and 6 month follow up. A score of 1 represents an equivocal or mild reduction in perfusion, 2 represents moderately reduced perfusion, 3 represents severely reduced perfusion, and 4 indicates absent perfusion.	6 months post-radiation

External Links

•   SKCCC Radiation Oncology