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Thalidomide for the Prevention of Radiation-induced Pharyngitis

A Multicenter, Randomized, Controlled, Double-blind Phase III Clinical Study of Thalidomide for the Prevention of Radiation-induced Pharyngitis in Head and Neck Cancer Patients

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500102715
Enrollment
Unknown
Registered
2025-05-19
Start date
2025-06-01
Completion date
Unknown
Last updated
2025-05-26

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

Conditions

Head and neck cancer

Interventions

Control group:Received conventional radiotherapy and placebo
Experimental group:Treated with conventional radiotherapy and thalidomide.

Sponsors

Zhejiang Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Gender is not limited; 2.Age 18-70 years old. 3.Pathologically confirmed head and neck carcinoma; 4.Performance Status 0-2; 5.Patients who received definitive or postoperative radiation therapy for head and neck region; 6.Enrolled patients must meet the following laboratory criteria: Hemoglobin (HGB) =100 g/L White blood cell count (WBC) >=4×10^9/L Platelet count (PLT) >=100×10^9/L (or WBC and platelet counts not below the lower limit of normal [LLN] per the institutional laboratory standards) Liver function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <1.5× upper limit of normal (ULN) Total bilirubin <1.5×ULN Renal function: Serum creatinine <1.5×ULN; 7.Able to comprehend the study and signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1.History of other malignancies that may compromise the safety or efficacy of the current treatment; 2.Ppregnant or lactating women; 3.Patients currently participating in other investigational drug trials; 4.Documented history of deep vein thrombosis; 5.Previous history of radiotherapy to the head and neck region; 6.History of recurrent oral inflammation and autoimmune disorders including but not limited to systemic lupus erythematosus; 7.Any other conditions that may interfere with the study as determined by the investigator.

Design outcomes

Primary

MeasureTime frame
Incidence of severe radiation-induced pharyngolaryngitis;

Secondary

MeasureTime frame
Quality of life;Incidence of adverse events (excluding radiation-induced pharyngolaryngitis);

Countries

China

Contacts

Public ContactHua Yonghong

Zhejiang Cancer Hospital

yonghonghua@163.com+86 571 88128202

Outcome results

None listed

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