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

NCT03437161 | Completed DMC

• 2 other identifiers: 16-01477s16-01477
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Breast Cancer

Keywords

Radiation; Prone position; Supine position; DIBH; Invasive Breast Carcinoma; Ductal Breast Carcinoma In Situ

Outcome Measures

Primary Outcomes (1)

• Mean cardiac dose

  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.

  Up to 6 weeks

Secondary Outcomes (12)

• Volume of heart receiving > 20 gray (Gy)

  Up to 6 weeks

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

  Up to 6 weeks

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

  Up to 6 weeks

• Mean ipsilateral lung dose

  Up to 6 weeks

• Volume of ipsilateral lung receiving > 20Gy

  Up to 6 weeks

Study Arms (1)

Radiation Therapy (RT)

EXPERIMENTAL

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.

Radiation: Radiation Therapy (RT)

Interventions

Radiation Therapy (RT) RADIATION

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

Also known as: Cancer Radiotherapy, Radiotherapy, RT

Radiation Therapy (RT)

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

MeSH Terms

Conditions

Breast Neoplasms; Deception; Carcinoma, Intraductal, Noninfiltrating

Interventions

Radiotherapy; Radiation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics; Physical Phenomena

Study Officials

• Naamit Gerber, MD

  Laura and Isaac Perlmutter Cancer Center at NYU Langone

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2018
• First Posted: February 19, 2018
• Study Start: January 17, 2017
• Primary Completion: September 26, 2017
• Study Completion: February 15, 2023
• Last Updated: February 17, 2023

Record last verified: 2023-02