A Phase 2 interventional study of Radiation therapy in Breast Cancer and Adverse Effect of Radiation Therapy, sponsored by AHS Cancer Control Alberta. Status unknown at 1 site in Canada. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2017-01-06.
Sponsored by AHS Cancer Control Alberta · Phase 2, Interventional, and Diagnostic
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.
12,543 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 63 is below the median of 72 across 9,302 interventional studies indexed under Breast Neoplasms.
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Exclusion Criteria:
Cohort 1 - No prior anthracycline-based chemotherapy or herceptin, deep inspiration breath hold breast radiation therapy
Radiation: Radiation therapy
Cohort II - no prior Anthracycline based chemotherapy or Herceptin and (ii) to receive FB RT (not able to hold breath for at least 20 seconds or does not have a minimum of 1.0 cm of heart on at least 3 slices (3mm slices) on the FB scan)
Radiation: Radiation therapy
Cohort III - Prior Anthracycline-based chemotherapy or Herceptin, and (ii) eligible to receive DIBH RT. (Patient has a minimum of 1.0 cm of heart on at least 3 slices (3mm slices) on the FB scan)
Radiation: Radiation therapy
Radiation related acute and long term functional changes in patients treated with deep-inspiration breath hold compared to free-breathing technique
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
Time frame: 12 months
Radiation dosimetric comparison
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
Time frame: 12 months
Plan to share: No
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This study is status unknown, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.
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AHS Cancer Control Alberta