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New treatment option for Radiotherapy-induced Oral Mucositis
Official title Traditional Chinese Medicine Preparation Alleviates Radiotherapy-induced Oral Mucositis in Head and Neck Cancer Patients.
ClinicalTrials.gov ID: NCT07339774
What this study is testing
What is Zishui Daohuo oral liquid combined with Kujiu mouthwash?
Zishui Daohuo oral liquid combined with Kujiu mouthwash is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for radiotherapy-induced oral mucositis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Evaluate the effectiveness and safety of traditional Chinese medicine compound in improving radiotherapy-induced oral mucositis in patients with head and neck malignant tumors.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Patients pathologically diagnosed with non-metastatic head and neck malignant tumors;
- Age range: 18 to 65 years old (including 18 and 65 years old);
- Eastern Cooperative Oncology Group performance status of ≤2;
- Radiotherapy or concurrent chemoradiotherapy is required;
- The main organ functions well;
You likely can't join if
- Allergic constitution (such as those known to be allergic to two or more drugs);
- Patients who plan to use drugs that can cause or worsen oral mucosal inflammation (such as anti EGFR monoclonal antibodies, immune checkpoint...
- Use of antibiotics, antifungal drugs, or antimicrobial mouthwash within 1 month of the study;
- Poor oral hygiene and/or severe periodontal diseases;
- History of head and neck radiotherapy;
- Deemed unsuitable for the study by the investigators (concomitant with any other severe diseases).
See the full eligibility criteria
- Patients pathologically diagnosed with non-metastatic head and neck malignant tumors;
- Age range: 18 to 65 years old (including 18 and 65 years old);
- Eastern Cooperative Oncology Group performance status of ≤2;
- Radiotherapy or concurrent chemoradiotherapy is required;
- The main organ functions well;
- Sign informed consent.
- Allergic constitution (such as those known to be allergic to two or more drugs);
- Patients who plan to use drugs that can cause or worsen oral mucosal inflammation (such as anti EGFR monoclonal antibodies, immune checkpoint inhibitors, etc.) after the start of radiotherapy;
- Use of antibiotics, antifungal drugs, or antimicrobial mouthwash within 1 month of the study;
- Poor oral hygiene and/or severe periodontal diseases;
- History of head and neck radiotherapy;
- Deemed unsuitable for the study by the investigators (concomitant with any other severe diseases).
The study team makes the final eligibility decision.
Where it's taking place
- Chengdu, Sichuan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chengdu, Sichuan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.