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

NCT ID: NCT02052102

Last Updated: 2017-01-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2017-03-31

Brief Summary

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

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.

Conditions

Breast Cancer; Adverse Effect of Radiation Therapy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

No prior therapy, DIBH irradiation

Cohort 1 - No prior anthracycline-based chemotherapy or herceptin, deep inspiration breath hold breast radiation therapy

Group Type: ACTIVE_COMPARATOR

Radiation therapy

Intervention Type: RADIATION

No prior therapy, FB technique

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)

Group Type: ACTIVE_COMPARATOR

Radiation therapy

Intervention Type: RADIATION

Prior therapy, DIBH irradiation

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)

Group Type: ACTIVE_COMPARATOR

Radiation therapy

Intervention Type: RADIATION

Interventions

Radiation therapy

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• Female patients with pathologically confirmed left sided breast cancer eligible for adjuvant breast/chest wall plus or minus regional nodal radiotherapy
• Women patients with age group between 18 and 70 years old
• Karnofsky performance score ≥ 70
• Ability to hold breath for at least 20 sec (for DIBH cohorts only)
• Life expectancy >10 years

Exclusion Criteria

• For patients with prior Anthracycline based chemotherapy or Herceptin, if there is < 1.0 cm of heart on at least 3 slices ( 3 mm slices) on the FB scan, the patient will be considered a screen failure.
• Previously irradiated or recurrent breast/chest wall tumours or previous malignancy other than non-melanoma skin cancer unless disease free for a minimum of 5 years prior to study entry
• Patients that require a shell for breast immobilization
• Patients requiring a boost
• Stage IV disease

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cross Cancer Institute

OTHER

Sponsor Role: collaborator

AHS Cancer Control Alberta

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kurian Joseph, MB, FFRRCSI, FRCR, FRCPC

Role: PRINCIPAL_INVESTIGATOR

Cross Cancer Institute

Locations

Cross Cancer Institute

Edmonton, Alberta, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Kurian Joseph, MB, FFRRCSI, FRCR, FRCPC

Role: CONTACT

kurian.joseph@albertahealthservices.ca

780-432-8755

Other Identifiers

Breast-26159

Identifier Type: -

Identifier Source: org_study_id