A Randomized, Controlled, Multicenter Clinical Trial of Compound Kushen Injection for preventing the radiotherapy related adverse reactions in head and neck neoplasms

Post-marketing Clinical Research on Compound Kushen Injection in Malignant Neoplasm.Treatment

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-IPR-14005481

Enrollment

Unknown

Registered

2014-10-16

Start date

2014-10-25

Completion date

Unknown

Last updated

2017-04-18

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

Conditions

Head and Neck Neoplasms

Interventions

A:Radiatherapy

B:Radiatherapy combined with Compound Kushen Injection

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Before the start of the study, All patients have been fully understood the reseach and the willingness to sign the informed consent; (2) Aged from 18 to 75 years; (3) The head and neck cancer diagnosis must be proved by pathology; (4) According to RECIST (version 1.1), At least 1 objectively measurable Tumor lesion (iconography: CT, MRI), the assessable lesion can be measured accurately, maximum diameter more than 10mm (Malignant lymph nodes on CT scans short diameter less than at least 15 mm); (5) Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2; (6) The function of each organ is basically normal: ANC more than 1.5*10^9/L, Platelet count more than 100*10^9/L, Hb more than 9.0g/dl, BIL at normal level or less than 1.5*ULN, AST (SGOT), ALT (SGPT) less than 2.5*ULN (less than 5*ULN, if completed with liver metastases), SCr less than 1.5*ULN; (7) The expected survival time must more than 6 months.

Exclusion criteria

Exclusion criteria: (1) Ever treated with Compound Kushen Injection within 2weeks (2) Pregnant or lactating women. (3) Patients with severe,uncontrolled organic lesions or infection, such as decompensated heart,lung,kidney failure can lead to tolerance of chemotherapy; (4) paticipating or within the last 30 days participated in other clinical trials; (5) Hypersensitiveness to any kind of trial regime. (6) Had a history of serious Psychological or Psychiatric disorders, Drug addiction or Alcohol dependence; (7) Estimating the compliance of patients to participate in this clinical trial is insufficient.

Design outcomes

Primary

Measure	Time frame
The incidence and the degree of adverse reactions caused by RT;	—

Secondary

Measure	Time frame
The rate of completing radiotherapy;Clinical Symptoms;Quality of Life;Objective Response Rate (ORR);Weight;ECOG PS;	—

Countries

China

Contacts

Public ContactHongsheng Lin

dr.liujie@163.com+86 13718716339

Outcome results

None listed

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