Prospective Assessment of Radiation-induced Heart Injury in Left-sided Breast Cancer

• Sponsor: Shu lian Wang (Other)
• Overall Status: Completed
• CT.gov ID: NCT03461588
• Collaborator: (none)
• Enrollment: 140
• Locations: 2
• Arms: 2
• Actual Duration (Months): 36.9
• Patients Per Site: 70
• Patients Per Site Per Month: 1.9

Study Details

Study Description

Brief Summary

This study is to prospectively investigate the cardiac dose-sparing effect and clinical benefit of deep inspiration breath-hold (DIBH) technique. Patients with left-sided breast cancer treated with breast conserving surgery followed by radiotherapy is enrolled. Radiotherapy is delivered with either free-breathing or deep inspiration breath-hold (DIBH) technique. The cardiac dose parameters and cardiac toxicity are prospective evaluated, and the dose-effect relationship is analyzed.

Condition or Disease	Intervention/Treatment	Phase
Breast Neoplasms; Heart Injuries; Radiation Toxicity	Radiation: free-breathing; Radiation: deep inspiratory breath-holding	N/A

Detailed Description

Patients with left-sided breast cancer treated with breast conserving surgery are prospectively enrolled. Two types of radiation treatment are delivered based on attending physician's preferences: radiation to whole breast +- regional nodal areas with free-breathing technique, or with deep inspiration breath-hold (DIBH) technique. The cardiac dose parameters including heart dose and the dose to left anterior coronary artery are assessed, and the cardiac toxicities regularly assessed with cardiac enzymes,electrocardiogram(ECG) and normal gated single-photon emission computed tomography-myocardial perfusion imaging before, during and after radiation.The dose-effect relationship of heart injuries is analyzed.

Study Design

• Study Type: Interventional
• Actual Enrollment: 140 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Prospective Assessment of Radiation-induced Heart Injury in Left-sided Breast Cancer Treated With Breast Conserving Surgery Followed by Radiotherapy With Free-breathing or Deep Inspiration Breath-hold (DIBH) Technique
• Actual Study Start Date: Jan 1, 2017
• Actual Primary Completion Date: Jan 30, 2020
• Actual Study Completion Date: Jan 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Free-breathing standard treatment	Radiation: free-breathing; patients are irradiated to whole breast +- regional nodal areas with free-breathing technique after breast conserving surgery
Experimental: Deep inspiratory breath-holding new technique	Radiation: deep inspiratory breath-holding; patients are irradiated to whole breast +- regional nodal areas with deep inspiratory breast-holding technique after breast conserving surgery

Outcome Measures

Primary Outcome Measures

1. Number of participants with treatment-related cardiac adverse events as assessed by CTCAE v4.0 [up to 2 years]

   The cardiac adverse events are regularly assessed with cardiac symptoms,cardiac enzymes(TnT，BNP),electrocardiogram(ECG) and normal gated single-photon emission computed tomography-myocardial perfusion imaging.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Left-sided breast cancer

2. Underwent breast conserving surgery

3. Planned for postoperative whole breast +- regional nodal radiotherapy

4. No basic heart disease

Exclusion Criteria:

1. Abnormal cardiac baseline examination

2. History of chest radiation

3. Can not tolerate deep inspiratory breath-holding

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cancer Hospital, Chinese Academy of Medical Sciences	Beijing		China	100021
2	Cancer Hosptical, Chinese Academy of Medical Sciences	Beijing		China	100021

Sponsors and Collaborators

• Shu lian Wang

Investigators

• Principal Investigator: Shulian Wang, M.D., Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Shu lian Wang, professor of medicine, Chinese Academy of Medical Sciences
• ClinicalTrials.gov Identifier: NCT03461588
• Other Study ID Numbers: LC2016A09
• First Posted: Mar 12, 2018
• Last Update Posted: Mar 25, 2020
• Last Verified: Mar 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Additional relevant MeSH terms: Breast Neoplasms; Unilateral Breast Neoplasms; Wounds and Injuries; Heart Injuries

Study Results

No Results Posted as of Mar 25, 2020