A Study to See Whether Breath-Hold Techniques During Radiation Radiation Treatment Are Effective in Helping to Improve Sparing of the Heart

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2014 by AHS Cancer Control Alberta
Sponsor:
Collaborator:
Cross Cancer Institute
Information provided by (Responsible Party):
AHS Cancer Control Alberta
ClinicalTrials.gov Identifier:
NCT02052102
First received: January 24, 2014
Last updated: January 29, 2014
Last verified: January 2014
  Purpose

The study hopes to determine whether patients with left-sided breast cancer are at an increased risk of cardiac changes due to radiation to the breast +/- Anthracycline-based chemotherapy +/- Herceptin and whether a deep inspiration breath hold (DIBH) technique during radiotherapy treatments would further reduce dosimetric dose to the heart as compared to the conventional free breathing (FB) technique thus reducing cardiac toxicity as measured by cardiac MRI using left ventricular end-diastolic volume (LVEDV) as a metric. Bio fluid samples will also be collected to investigate specific biomarkers of breast cancer: BNP, PIIINP and CITP


Condition Intervention Phase
Breast Cancer
Adverse Effect of Radiation Therapy
Radiation: Radiation therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Cohort Study Assessing Cardiac Function With MRI in Left-Sided Breast Cancer Patients Treated With Deep Inspiration Breath Hold (DIBH) Technique to Improve Cardiac Sparing During Adjuvant Radiotherapy

Resource links provided by NLM:


Further study details as provided by AHS Cancer Control Alberta:

Primary Outcome Measures:
  • Radiation related acute and long term functional changes in patients treated with deep-inspiration breath hold compared to free-breathing technique [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Using MRI-based cardiac functional imaging to measure radiation-related acute and long term cardiac functional changes in patients treated with deep-inspiration breath-hold (DIBH) compared to free breathing (FB) treatment


Secondary Outcome Measures:
  • Radiation dosimetric comparison [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Radiation dosimetry is the accurate calculation and measurement of radiation doses received by tissue resulting from the exposure to radiation. A radiation dosimetric comparison will be performed between the deep inspiration breath hold (DIBH) technique treatment plan and the free breathing (FB) technique treatment plan to explore sparing of cardiac sub-structures from radiation, if any


Estimated Enrollment: 63
Study Start Date: February 2014
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: No prior chemo or herceptin, DIBH irradiation
Cohort 1 - No prior anthracycline-based chemotherapy or herceptin, deep inspiration breath hold breast radiation therapy
Radiation: Radiation therapy
Active Comparator: No prior therapy, FB technique
Cohort II - No prior Anthracycline-based chemo or Herceptin, free breathing breast radiation therapy
Radiation: Radiation therapy
Active Comparator: Prior therapy, DIBH irradiation
Cohort III - Prior Anthracycline-based chemotherapy or Herceptin, deep inspiration breath hold breast radiation therapy
Radiation: Radiation therapy

Detailed Description:

Patients with left-sided breast cancer who receive adjuvant breast or chest wall radiation have increased risk of treatment related cardiovascular morbidity. The risk of cardiac morbidity and mortality is increased when a patient receives radiation following adjuvant chemotherapy and Herceptin. The dose-volume histogram (DVH) parameters associated with increased cardiac toxicity include volume of heart irradiated, total radiation dose received by the left ventricle (LV), V25 and mean cardiac dose. Even though modern RT treatments like 3DCRT and IMRT can reduce the mean dose to the heart, the maximum dose to the left side of the heart/LV may not be reduced if the target is close to the heart. The hypothesis is that DIBH RT can safely and effectively reduce the heart dose, especially the dose to the LV, that could lead to reduction in the incidence of radiation induced cardiovascular morbidity and mortality.

Radiotherapy has detrimental effects on cardiac function due to remodeling of the cardiac tissue that receive radiation. We believe that the radiation related acute effects on heart tissue can be detected with cardiac functional MRI. The study will quantify the acute RT related effects. To our knowledge, cardiac MRI has not been explored as a non invasive technique to quantify RT +/- chemotherapy related effects.

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female patients with pathologically confirmed left-sided node positive breast cancer eligible for adjuvant breast/chest wall and regional nodal radiotherapy (including IMN)
  • Female patients with age between 40 and 70 years
  • Karnofsky performance score ≥ 70
  • Ability to hold breath for at least 15 - 20 seconds (to participate in DIBH study arms)
  • Life expectancy > 10 years

Exclusion Criteria:

  • < 1.0 cm involvement of the left ventricle in the free breathing scanning
  • History of uncontrolled hypertension or myocardial infarction, heart failure, cardiomyopathy, or baseline LVEF < 50% or severe COPD
  • Anti-hypertensive therapy with ACE-inhibitors, Angiotensin receptor blockers or beta blockers
  • Patient requiring boost
  • Stage IV disease or DCIS
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02052102

Contacts
Contact: Kurian Joseph, MB, FFRRCSI, FRCR, FRCPC 780-432-8755 kurian.joseph@albertahealthservices.ca

Locations
Canada, Alberta
Cross Cancer Institute Not yet recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Sponsors and Collaborators
AHS Cancer Control Alberta
Cross Cancer Institute
Investigators
Principal Investigator: Kurian Joseph, MB, FFRRCSI, FRCR, FRCPC Cross Cancer Institute
  More Information

No publications provided

Responsible Party: AHS Cancer Control Alberta
ClinicalTrials.gov Identifier: NCT02052102     History of Changes
Other Study ID Numbers: Breast-26159
Study First Received: January 24, 2014
Last Updated: January 29, 2014
Health Authority: Canada: Health Canada

Keywords provided by AHS Cancer Control Alberta:
Deep inspiration breath hold
radiation therapy
Cardiac toxicity
Left-sided breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on August 28, 2014