Clinical trial NCT00321048: Spect Analysis of Cardiac Perfusion Changes After Whole Breast/Chest Wall Radiation Therapy With ABC
Official title: Spect Analysis of Cardiac Perfusion Changes After Whole Breast/Chest Wall Radiation Therapy With Active Breathing Coordinator
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Neoplasms
Carcinoma, Ductal
Adenocarcinoma
Keywords: breast cancer
SPECT
ABC device
Invasive adenocarcinoma of the left breast
Ductal Carcinoma In Situ of the left breast
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
Collaborators: name: Breast Cancer Research Foundation
First posted: 2006-05-03
Enrollment: 57
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Left breast/chest wall irradiation with or without ABC (active breathing coordinator)
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: Efficacy of Active Breathing Coordinator (ABC) Device as Determined by the Mean Apical Perfusion Score
timeFrame: Baseline (pre-radiation) to 6 months (post-radiation)
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
state: Maryland
Study officials:
affiliation: Sidney Kimmel Comprehensive Cancer Center- Dept. Radiation Oncology
name: Richard Zellars, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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 randomized phase 3 trial. Int J Radiat Oncol Biol Phys. 2014 Mar 15;88(4):778-85. doi: 10.1016/j.ijrobp.2013.12.035.