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Clinical efficacy and safety observation of Nahao spray in the prevention and treatment of oral mucositis/acute skin injury caused by tumor radiotherapy

Clinical efficacy and safety observation of Nahao spray in the prevention and treatment of oral mucositis/acute skin injury caused by tumor radiotherapy

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300072590
Enrollment
Unknown
Registered
2023-06-19
Start date
2023-06-19
Completion date
Unknown
Last updated
2023-06-26

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

Conditions

Oral mucositis and radiation dermatitis

Interventions

Oral Mucositis Group:Nahao Spray
Radiation dermatitis group:Nahao Spray

Sponsors

Jiangsu Cance Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Oral Mucositis Group Patients are prepared to receive head and neck radiation therapy with or without chemotherapy,patients are over 18 years old, regardless of gender, can clearly describe symptoms, voluntarily participate in this study, sign an informed consent form, and have a quality of life score and functional status score (Karnofsky) greater than 50. Radiation dermatitis group Patients who are preparing to receive head and neck or breast radiation therapy with or without chemotherapy, with a radiation intensity of 40 Gy or more, age greater than 18 years old, regardless of gender, can clearly describe symptoms, voluntarily participate in this study, sign an informed consent form, and have an activity status score (ECOG) of = 2.

Exclusion criteria

Exclusion criteria: Oral Mucositis Group Patients with oral mucosal diseases before starting radiotherapy, and those who are allergic to the test drug or any of its components; Patients who use other mucosal protectors one week before radiotherapy; Patients with liver and kidney dysfunction, neurological or psychiatric abnormalities; Patients with poor compliance. Radiation dermatitis group Patients with severe and uncontrolled organic lesions or infections, patients who use other skin and mucosal protective agents during radiotherapy, patients who are participating in or have participated in similar clinical studies within the past 30 days, and patients who are allergic to any component of the investigational drug.

Design outcomes

Primary

MeasureTime frame
The incidence of oral mucosal inflammation;Remission rate of radiation dermatitis;

Secondary

MeasureTime frame
Oral mucositis pain score;Quality of life score;Symptom burden of skin damage in the dermatitis group;Oral mucotitis group functional status score;Dermatitis group functional status score;

Countries

China

Contacts

Public ContactDan song

Jiangsu Cancer Hospital

sd13655184828@163.com+86 136 5518 4828

Outcome results

None listed

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