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Completed

NCT Number: NCT03437161

A Prospective Trial to Compare Deep Inspiratory Breath Hold (DIBH) With Prone Breast Irradiation

This phase II trial studies how well deep inspiratory breath hold or prone breast radiation therapy works in reducing cardiac dose in patients with breast cancer or ductal carcinoma in situ. Deep inspiratory breath hold is a technique that involves a patient holding their breath during radiation to move the heart away from the breast to minimize radiation to the heart. Prone breast radiation therapy is a technique in which a patient receives treatment "face-down" to minimize the radiation to the rest of the body, including the heart and lungs. Comparing deep inspiratory breath hold to prone breast radiation therapy may help doctors improve radiation to the target while reducing radiation to healthy tissues surrounding the target.

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Key information

Conditions

Breast Cancer Adenocarcinoma Behavior Breast Carcinoma In Situ Breast Diseases Breast Neoplasms Carcinoma Carcinoma in Situ Carcinoma, Intraductal, Noninfiltrating Deception Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Ductal, Lobular, and Medullary Neoplasms, Glandular and Epithelial Skin Diseases Skin and Connective Tissue Diseases Social Behavior

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

Patients attend a simulation visit and undergo two CT scans, one in the prone position and one in the supine position with DIBH. Within 1 week after the simulation visit, patients undergo radiation therapy either in the supine position with DIBH or in the prone position daily for 15-30 consecutive days as per physician's prescription

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Any woman with biopsy proven left breast DCIS or invasive cancer who has undergone a lumpectomy and who requires whole breast irradiation to the breast alone (and not to any nodal regions) as per the treating radiation oncologist

Exclusion criteria

  • Previous radiation to the ipsilateral breast
  • All pre-menopausal women will require a urine qualitative pregnancy test to exclude pregnancy; pregnant women will be excluded from the study

Treatment and study plan

Radiation Therapy (RT)

Radiation

Undergo RT either in the supine position with DIBH or in the prone position.

Other names: Cancer Radiotherapy, Radiotherapy, RT

Primary outcomes

  1. Mean cardiac dose

    Time frame: Up to 6 weeks

    Assess whether the mean cardiac dose in the supine DIBH plan differs from the mean cardiac dose in the prone plan within strata defined by total RT dose.

Secondary outcomes

  1. Volume of heart receiving > 20 gray (Gy)

    Time frame: Up to 6 weeks

    The volume of heart receiving >20Gy in DIBH plan vs. prone plan

  2. Mean left anterior descending artery (LAD) dose in DIBH plan vs. prone plan

    Time frame: Up to 6 weeks

    The mean LAD dose in DIBH plan vs. prone plan

  3. Maximum left anterior descending artery (LAD) dose in DIBH plan vs. prone plan

    Time frame: Up to 6 weeks

    The maximum LAD dose in DIBH plan vs. prone plan

  4. Mean ipsilateral lung dose

    Time frame: Up to 6 weeks

    The mean ipsilateral lung dose in DIBH plan vs. prone plan

  5. Volume of ipsilateral lung receiving > 20Gy

    Time frame: Up to 6 weeks

    The volume of ipsilateral lung receiving >20Gy in DIBH plan vs. prone plan

  6. Volume of the contralateral breast receiving > 5 Gy

    Time frame: Up to 6 weeks

    The volume of the contralateral breast receiving >5Gy in DIBH plan vs. prone plan

  7. Maximum point dose to planning target volume (PTV) breast

    Time frame: Up to 6 weeks

    The maximum point dose to PTV breast in DIBH plan vs. prone plan

  8. Maximum separation

    Time frame: Up to 6 weeks

    The maximum separation in DIBH plan vs. prone plan

  9. Distance from the mid-sternum to the nipple when the patient is in the prone position

    Time frame: Up to 6 weeks

    Distance from the mid-sternum to the nipple when the patient is in the prone position

  10. PTV breast volume as calculated on the prone scan

    Time frame: Up to 6 weeks

    PTV breast volume as calculated on the prone scan

  11. Change in distance between the chest wall and heart (at the most lateral portion of the chest-wall-heart interface)

    Time frame: Up to 6 weeks

    The change in distance between the chest wall and heart (at the most lateral portion of the chestwall-heart interface) between the free breathing scout films and the DIBH scout films

  12. Patient treatment plan (supine with DIBH or prone)

    Time frame: Up to 6 weeks

    Will be described by proportions and frequency distributions. Logistic regression will be used to assess how each of the covariates (primary and secondary endpoints) affects the probability of being selected to undergo RT using the supine DIBH plan. ROC curves will be generated for various cut-points of the true proportion of patients requiring the supine DIBH plan.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2023
First posted
Feb 19, 2018
Registry last updated
Feb 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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