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Evaluation of the cardiac dose effect of hypofractionated simultaneous boosted radiotherapy with active breathing control after breast-conserving surgery for early stage left-sided breast cancer: a prospective study

Evaluation of the cardiac dose effect of hypofractionated simultaneous boosted radiotherapy with active breathing control after breast-conserving surgery for early stage left-sided breast cancer: a prospective study

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300076536
Enrollment
Unknown
Registered
2023-10-11
Start date
2023-10-16
Completion date
Unknown
Last updated
2023-11-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Interventions

Test group:Deep inspiration breath holding-active breathing control during radiotherapy
Control group:Radiation dose to organs at risk

Sponsors

Sichuan Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) Women aged 18-70; (2) New-diagnosed patients with early left-sided breast cancer; (3) Receive standardized breast-conserving surgery and postoperative histopathology of invasive carcinoma with a pathological stage of pT1-2N0M0; (4) At least five titanium clips around the tumor bed, or clear signs of seroma; (5) No history of underlying heart disease (including acute and chronic cardiac insufficiency, coronary heart disease, cardiomyopathy, congenital heart disease, etc.) and normal heart baseline examination results before radiotherapy; (6) The patient meets the requirements of deep inhalation and breath-holding during radiotherapy after standard breathing training: skillfully cooperate with the ABC device to ensure that the breath-holding time is >30s each time, the inspiratory volume is >1L, and the above actions can be repeated 5-6 times. (7) Informed consent.

Exclusion criteria

Exclusion criteria: (1) Pregnant women; (2) The patient has a history of chest radiotherapy; (3) Extensive lesions, and difficulty in achieving negative margins or ideal breast-conserving appearance; (4) Those with no tumor bed area or unclear identification; (5) Inflammatory breast cancer; (6) Cannot tolerate radiation therapy.

Design outcomes

Primary

MeasureTime frame
The incidence of cardiac events within 2 weeks after radiotherapy;

Secondary

MeasureTime frame
The incidence of cardiac events within 1 year after radiotherapy;

Countries

China

Contacts

Public ContactJun Yin

Sichuan Cancer Hospital

gzyinjun@163.com+86 139 8099 4326

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026