Using hydroxychloroquine to prevent and treat oral mucositis from radiation therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety, tolerance, and efficacy of hydroxychloroquine sulfate tablets in preventing and treating oral mucositis and dysgeusia in patients undergoing radiotherapy for non-metastatic head and neck malignant tumors. Participants will be randomly assigned to receive either hydroxychloroquine or a placebo. The study aims to determine whether hydroxychloroquine can effectively reduce the incidence and severity of oral mucositis associated with radiation treatment.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients pathologically diagnosed with non-metastatic head and neck malignant tumors
* Aged 18-80 years
* Eastern Cooperative Oncology Group performance status of ≤2
* Planning to receive definitive RT or postoperative adjuvant RT
* Normal liver, kidney and bone marrow function
* Sign informed consent

Exclusion Criteria:

* Those who are known to be allergic to 4-aminoquinoline compounds or have more serious allergic constitution
* Had a history of head and neck radiotherapy
* Patients with non head and neck parts in the radiotherapy area
* Poor oral hygiene or severe periodontitis
* Suffering from severe kidney disease, severe cardiovascular disease, myasthenia gravis, Parkinson's disease or epilepsy
* Recently taking or taking diuretics or other drugs known to interact with hydroxychloroquine sulfate tablets
* Retinopathy
* Other patients (combined with any serious other diseases) who the investigator believes are not suitable for participation in this study

Where it's running

• Department of Radiation Oncology
  Chengdu, Sichuan, China Recruiting

Study contacts

• Study coordinator: Peng xingchen Professor
• Email: pxx2014@scu.edu.cn
• Phone: +86 1880606753

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Houyanqing oral liquid to prevent and treat radiation mouth sores in nasopharyngeal cancer

  This phase 3 trial will test whether adding Houyanqing oral liquid to standard care can prevent or lessen radiation-caused mouth sores in adults receiving radiotherapy for nasopharyngeal cancer.

  Recruiting at 16 sites Phase 3 Sun Yat-sen University · Beijing, Beijing Municipality and 15 other locations · NCT07311772

• TCM oral liquid plus herbal mouthwash for radiation‑caused mouth sores in head and neck cancer

  This study will test whether taking a Qingying oral liquid and using a modified Da Huang‑Huang Lian Xiexin mouthwash can reduce how often, how long, and how severe radiation‑induced mouth sores are in adults receiving radiotherapy for head and neck cancer.

  Recruiting Phase 2 West China Hospital · Chengdu, Sichuan · NCT07282483

• Rice bran for radiation-related mouth sores in head and neck cancer

  This trial will try rice bran supplements during radiation to see if adults with head and neck cancer have fewer or less severe mouth sores.

  Recruiting German University in Cairo · Cairo · NCT07242859

• Taurine to prevent radiation-induced mouth sores and skin reactions

  This trial will test whether taking a daily taurine granule before each radiotherapy session reduces radiation-induced oral mucositis and radiodermatitis in adults receiving postoperative radiotherapy for oral/oropharyngeal cancer.

  Recruiting Phase 2 Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University · Shanghai, Shanghai Municipality · NCT07029178

• Observational study on a new method for managing radiation-induced mouth sores in cancer patients

  This study is testing a new method to see if it can help predict and manage mouth sores in cancer patients receiving radiation treatment for nasopharyngeal carcinoma.

  Recruiting Nanfang Hospital, Southern Medical University · Guangzhou, Guangdong and 9 other locations · NCT06308328

• A method to predict radiation-induced mouth sores in cancer patients

  This study is testing a new way to predict if cancer patients receiving radiation for throat cancer will develop painful mouth sores, to help improve their treatment experience.

  Recruiting Nanfang Hospital, Southern Medical University · Guangzhou, Guangdong · NCT06287788

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.