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 currently recruiting participants. (see Contacts and Locations)
Verified October 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: October 1, 2014
Last verified: October 2014

January 24, 2014
October 1, 2014
October 2014
February 2016   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT02052102 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
A Study to See Whether Breath-Hold Techniques During Radiation Radiation Treatment Are Effective in Helping to Improve Sparing of the Heart
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

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

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Breast Cancer
  • Adverse Effect of Radiation Therapy
Radiation: Radiation therapy
  • 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
    Intervention: Radiation: Radiation therapy
  • Active Comparator: No prior therapy, FB technique
    Cohort II - No prior Anthracycline-based chemo or Herceptin, free breathing breast radiation therapy
    Intervention: Radiation: Radiation therapy
  • Active Comparator: Prior therapy, DIBH irradiation
    Cohort III - Prior Anthracycline-based chemotherapy or Herceptin, deep inspiration breath hold breast radiation therapy
    Intervention: Radiation: Radiation therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
63
March 2017
February 2016   (final data collection date for primary outcome measure)

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
Female
40 Years to 70 Years
No
Contact: Kurian Joseph, MB, FFRRCSI, FRCR, FRCPC 780-432-8755 kurian.joseph@albertahealthservices.ca
Canada
 
NCT02052102
Breast-26159
Yes
AHS Cancer Control Alberta
AHS Cancer Control Alberta
Cross Cancer Institute
Principal Investigator: Kurian Joseph, MB, FFRRCSI, FRCR, FRCPC Cross Cancer Institute
AHS Cancer Control Alberta
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP