Recruiting
Phase 2

Breath-Hold Techniques

Sponsor:

AHS Cancer Control Alberta

Code:

NCT02052102

Conditions

Breast Cancer

Adverse Effect of Radiation Therapy

Eligibility Criteria

Sex: Female

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Radiation therapy

Study Details

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

Conditions

Breast Cancer

Adverse Effect of Radiation Therapy

Study ID

NCT02052102

Start date

Oct, 2014

Status verified date

Jan, 2017

Completion date

Mar, 2017

Anticipated

Primary completion date

Feb, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 70

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

63 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

active comparator: No prior therapy, DIBH irradiation

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

active comparator: 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)

active comparator: 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)

Interventions

Radiation therapy

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 ]

Central Contacts and Locations

Central contacts

Kurian Joseph, MB, FFRRCSI, FRCR, FRCPC

780-432-8755kurian.joseph@albertahealthservices.ca

Locations

Cross Cancer Institute

Recruiting

Edmonton, Alberta, Canada, T6G 1Z2

More Information

Sponsor

AHS Cancer Control Alberta

Last update posted

Jan 6, 2017

Last verified

Jan, 2017

Keywords

  • Deep inspiration breath hold
  • radiation therapy
  • Cardiac toxicity
  • Left-sided breast cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by AHS Cancer Control Alberta on 2017-01-06.