Modified Dahuang Huanglian Xiexin Mouthwash for the Prevention of Radiotherapy-Induced Oral Mucositis (RTOM): A Multicenter, Randomized, Controlled Trial
Overview
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Enrollment
- 156
- Primary Endpoint
- Incidence of Radiation-Induced Oral Mucositis Within 2 Weeks of Radiotherapy Initiation
Overview
Brief Summary
This is a multicenter, randomized, controlled, prospective clinical trial designed to observe and evaluate the safety and efficacy of Modified Dahuang Huanglian Xiexin Mouthwash for the prevention of radiotherapy-induced oral mucositis (RTOM).
Participants will be randomly assigned to receive either the Modified Dahuang Huanglian Xiexin Mouthwash or Placebo Mouthwash. The study aims to assess the preventative effect on RTOM in patients undergoing radiotherapy.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
This is a quadruple-blind study. Participants, care providers, investigators, and outcome assessors are all blinded to group assignment. The placebo mouthwash is identical in appearance, taste, smell, and packaging to the active Modified Dahuang Huanglian Xiexin Mouthwash to ensure successful blinding.
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Aged 18 to 70 years (inclusive) at the time of screening.
- •Histologically confirmed squamous cell carcinoma of the nasopharynx, oral cavity, or oropharynx.
- •Planned to receive radiotherapy.
- •No prior history of radiotherapy to the head and neck region.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Adequate major organ function as defined by the following criteria (within 14 days prior to enrollment, without transfusion support):
- •Hemoglobin (Hb) ≥90 g/L Absolute neutrophil count (ANC)≥1.5×10⁹/L Platelet count (PLT) ≥80×10⁹/L Total bilirubin (BIL) \< 1.25×upper limit of normal (ULN) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< 2.5×ULN Serum creatinine (Cr)≤ULN, or calculated creatinine clearance (Cockcroft-Gault formula) \> 50 mL/min
- •Signed written informed consent prior to any study-related procedures.
- •Judged by the investigator to be able to comply with the study protocol.
- •Negative pregnancy test (for women of childbearing potential) at screening.
Exclusion Criteria
- •Pre-existing oral mucositis prior to the start of radiotherapy.
- •Prior radiotherapy to the head and neck region.
- •Major surgery within 3 weeks prior to enrollment.
- •Uncontrolled cardiac conditions or symptoms, including but not limited to:
- •New York Heart Association (NYHA) class II or higher heart failure Unstable angina pectoris Myocardial infarction within 1 year prior to enrollment Clinically significant supraventricular or ventricular arrhythmia requiring intervention
- •Use of topical (oral) or systemic corticosteroids within 1 week prior to enrollment.
- •Active infection requiring systemic therapy.
- •Known history of substance abuse, alcohol abuse, or drug addiction.
- •Pregnancy or breastfeeding.
- •Any other condition that, in the investigator's judgment, may interfere with the participant's ability to complete the study or compromise the collection of study data, including but not limited to serious concurrent illness (including psychiatric disorders) requiring concomitant treatment, severely abnormal laboratory values, or unfavorable family or social circumstances.
Arms & Interventions
Control arm
Placebo mouthwash matching the active intervention in appearance, color, taste, and packaging, containing no active pharmaceutical ingredients. It consists of purified water, pharmaceutical-grade coloring and flavoring agents to mimic the characteristics of the Modified Dahuang Huanglian Xiexin Mouthwash. Patients in this arm are instructed to rinse with 10 mL of the placebo solution for 2-3 minutes, six times daily, starting from the first day of radiotherapy and continuing throughout the radiotherapy course. All participants receive the same radiotherapy regimen and standard oral care. This arm serves as a control to evaluate the efficacy of the active intervention under double-blind conditions.
Intervention: Placebo Mouthwash (Drug)
Experimental arm
Modified Dahuang Huanglian Xiexin Mouthwash (Jiawei Dahuang Huanglian Xiexin Koufuye), an active Chinese herbal formulation. Patients in this arm are instructed to rinse with 10 mL of the active solution for 2-3 minutes, six times daily, starting from the first day of radiotherapy and continuing throughout the radiotherapy course. All participants receive the same radiotherapy regimen and standard oral care. This arm serves as the experimental intervention to evaluate its efficacy in reducing radiation-induced oral mucositis compared with a matched placebo under double-blind conditions.
Intervention: Modified Dahuang Huanglian Xiexin Mouthwash (Drug)
Outcomes
Primary Outcomes
Incidence of Radiation-Induced Oral Mucositis Within 2 Weeks of Radiotherapy Initiation
Time Frame: From start of radiotherapy to the 2-week assessment point (day 14 ± 3 days)
Proportion of participants who develop radiation-induced oral mucositis (RTOM) of any grade within 2 weeks after the start of radiotherapy, assessed using the WHO Oral Toxicity Scale or RTOG Acute Radiation Morbidity Scoring Criteria. Participants who develop grade ≥3 RTOM prior to the 2-week assessment point are also counted as having reached the primary endpoint.
Secondary Outcomes
- Time to Onset of Radiation-Induced Oral Mucositis(From start of radiotherapy until 7 days after completion of radiotherapy, assessed up to 8 weeks (56 days) from start of radiotherapy.)
- Weekly Oropharyngeal Pain Score Measured by OMWQ(weekly from start of radiotherapy to 7 days post-radiotherapy, assessed up to 56 days, or until occurrence of grade ≥3 RTOM, whichever comes first.)
- Weekly Body Weight Change During Radiotherapy(weekly from start of radiotherapy to 7 days post-radiotherapy, assessed up to 56 days, or until occurrence of grade ≥3 RTOM, whichever comes first.)
- Quality of Life (EORTC QLQ-H&N35)(weekly from start of radiotherapy to 7 days post-radiotherapy, assessed up to 56 days, or until occurrence of grade ≥3 RTOM, whichever comes first.)