Deep Inspiration Breath-hold Radiotherapy for Left-sided Breast Cancer

Deep Inspiration Breath-hold Radiotherapy for Left-sided Breast Cancer in Reducing Early Cardiac Injury: a Phase II Prospective Study

Postoperative breast radiotherapy (RT) has been associated with increased risk of heart toxicity. However, there is a lack of knowledge for radiation-induced early cardiovascular injury, especially for hypofractionated RT. This study aims to prospectively detect and predict early clinical or subclinical cardiac events in women undergoing adjuvant RT for breast cancer.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Cardiac Event
• Intervention / Treatment: Device: Deep inspiration breath-hold technique

Detailed Description

Women with left-sided breast cancer undergo hypofractionated RT at either free-breathing or deep inspiration breath-hold. The incidence and potential clinical, dosimetric and biological indicators of early clinical or subclinical cardiac injury are investigate at 2 years.

• Study Type: Observational
• Enrollment (Anticipated): 166

Contacts and Locations

• Study Contact: Name: Shu-Lian Wang; Phone Number: 86-13366191993; Email: wangsl@cicams.ac.cn

Study Locations

• China
  • Beijing, China, 100021
    • Recruiting
    • Cancer hospital, Chinese Academy of Medical Sciences
    • Contact: Shu-Lian Wang; Phone Number: 8610-87787659; Email: wangsl@cicams.ac.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

women with left-sided breast cancer planning for adjuvant radiotherapy

Description

Inclusion Criteria:

• Primary left-sided breast cancer post surgery
• Planning for adjuvant breast/chest wall +-RNI

Exclusion Criteria:

• History of cardiovascular disease
• Previous chest radiation
• Bilateral breast cancers

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Radiotherapy at free-breathing; breast/chest wall+-RNI 43.5Gy/15f/3w（tumor bed 49.5Gy/15f/3w) delivered at free-breathing
Radiotherapy at deep inspiration breath-hold; breast/chest wall+-RNI 43.5Gy/15f/3w（tumor bed 49.5Gy/15f/3w) delivered at deep inspiration breath-hold	Device: Deep inspiration breath-hold technique; Selective application of deep inspiration breath-hold technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of clinical or subclinical cardiac injury	predefined cardiac events	two years

Collaborators and Investigators

• Sponsor: Shu lian Wang

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Anticipated): June 30, 2022
• Study Completion (Anticipated): June 30, 2023

Study Registration Dates

• First Submitted: December 13, 2021
• First Submitted That Met QC Criteria: January 6, 2022
• First Posted (Actual): January 20, 2022

Study Record Updates

• Last Update Posted (Actual): January 20, 2022
• Last Update Submitted That Met QC Criteria: January 6, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Unilateral Breast Neoplasms
• Other Study ID Numbers: 2020-2-4023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No