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Clinical study of valsartan reducing the incidence of grade 2 or higher radiation pneumonitis after thoracic radiotherapy

Clinical study of valsartan reducing the incidence of grade 2 or higher radiation pneumonitis after thoracic radiotherapy

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200062762
Enrollment
Unknown
Registered
2022-08-18
Start date
2022-08-18
Completion date
Unknown
Last updated
2023-04-12

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

Conditions

lung cancer

Interventions

A:valsartan

Sponsors

Ji'nan Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age >= 18 years old, both male and female are Ok. 2. Pathologically proven lung cancer patients, who are at advanced stages or locally advanced stage or inoperable early stage 3. ECOG score 0-1. 4. Life expectancy is more than 3 months. 5. Full organ function: expected survival time > 3 months; 6. Adequate hematopoietic function and liver and kidney function: A. neutrophil count >= 1.5 x 10^9/L; B. White blood cell count >= 3 x10^9/L; C. Platelet count >= 80 x 10^9/L; D. Hemoglobin >= 90g/L; E. Creatinine <= 1.5 x ULN; F. Alanine aminotransferase (AST) and aspartate aminotransferase (ALT) <=2.5x ULN (<=5 x ULN for liver metastases); H. Total bilirubin <= 1.5 x ULN (<=3 x ULN for liver metastases); I. Alkaline phosphatase <= 5 x ULN; 7.patients are planned to receive conventional fractionated thoracic radiotherapy (single irradiation dose 1.8-2.0Gy), and the planned irradiation dose was more than 45Gy 8. Sign the informed consent form

Exclusion criteria

Exclusion criteria: 1. Patients with resting blood pressure less than 110/60 mmhg 2. Inability to swallow ,or a condition that investigators judge to severely impair gastrointestinal absorption (eg, chronic Diarrhea, intestinal obstruction, etc.). 3. Patients with severe pulmonary dysfunction disease, such as interstitial disease, severe chronic obstructive pulmonary disease (COPD), or thoracic radiotherapy is contraindicated 4.History of severe cardiovascular and cerebrovascular disease (hypertensive patients with stable blood pressure control may be admitted, but valsartan should be included in antihypertensive medication) 5. There are contraindications to oral valsartan, such as renal artery stenosis and severe renal impairment. 6. In the investigators' opinion , the patients are not eligible to participate in the study due to any clinical or laboratory abnormalities or other reasons 7. Previous thoracic radiotherapy

Design outcomes

Primary

MeasureTime frame
Incidence of grade 2 or higher radiation pneumonitis within 3 months after radiotherapy;

Secondary

MeasureTime frame
Safety and tolerability of concomitant oral valsartan with thoracic radiotherapy;

Countries

China

Contacts

Public ContactMeili Sun
smli1980@163.com+86 18953116532

Outcome results

None listed

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