A multicenter randomized controlled study of Brucea oil oral emulsion for the prevention of acute radiation lung injury by radiotherapy for small cell lung cancer

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ITMCTR

Registry ID

ITMCTR2026000084

Enrollment

Unknown

Registered

2026-01-17

Start date

2025-01-21

Completion date

Unknown

Last updated

2026-02-02

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

Conditions

Lung cancer

Interventions

Trial Group:Patients received concurrent radiotherapy combined with Brucea Javanica Oil Oral Emulsion treatment, followed by a 1-year follow-up. The administration duration of Brucea Javanica Oil Oral

Control Group:Only received standard protocol radiotherapy and 1-year follow-up.

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Aged between 18 and 75 years old (inclusive), regardless of gender; 2.Pathologically confirmed small-cell lung cancer (SCLC); 3.Patients assessed by the attending physician as requiring radiotherapy; 4.Patients with a Karnofsky Performance Status (KPS) score > 60; 5.Study participants and their family members (or legal representatives) have signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1.Patients with known or suspected allergies to the drugs used in this study; 2.Patients with a history of chest radiotherapy; patients with chest skin ulceration and infection; or patients with pleural effusion; 3.Patients with chronic lung disease, interstitial lung disease, or pneumonia; 4.Patients with severe abnormalities in the function of the heart, lungs, liver, kidneys, hematopoietic system, or other vital organs; 5.Patients diagnosed with mental illnesses such as depression or schizophrenia; 6.Patients who have participated in other clinical trials within the past month, or used traditional Chinese medicines with anti-tumor effects within 7 days before using the study drug; 7.Patients deemed unsuitable for participation in this study by the researcher(s).

Design outcomes

Primary

Measure	Time frame
Incidence and Grading of Radiation Pneumonitis;	—

Secondary

Measure	Time frame
Overall Survival (OS);Progression-Free Survival(PFS);Karnofsky Performance Status (KPS);TCM Syndrome Points;	—

Countries

China

Contacts

Public ContactCui Xiaonan

The second Department of Oncology, First Affiliated Hospital, Dalian Medical University

cxn23@sina.com18098876725

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 7, 2026