Traditional Chinese Medicine for the Prevention of Radiotherapy-Induced Oral Mucositis (RTOM)

Official title

Modified Dahuang Huanglian Xiexin Mouthwash for the Prevention of Radiotherapy-Induced Oral Mucositis (RTOM): A Multicenter, Randomized, Controlled Trial

Overview

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.

Interventions

• Drug Modified Dahuang Huanglian Xiexin Mouthwash
  A Chinese herbal mouthwash formulation derived from the classic formula Dahuang Huanglian Xiexin Decoction, with additional ingredients to enhance its properties for radiation-induced oral mucositis. The active ingredients include Rhei Radix et Rhizoma, Coptidis Rhizoma, Scutellariae Radix, and other botanical components. It is prepared as a ready-to-use aqueous solution with standardized extraction and quality control procedures. The mouthwash is administered as 10 mL per use, held in the oral
• Drug Placebo Mouthwash
  A placebo mouthwash formulated to match the active intervention (Modified Dahuang Huanglian Xiexin Mouthwash) in appearance, color, taste, and packaging. It contains no active pharmaceutical ingredients and is composed of purified water with pharmaceutical-grade coloring and flavoring agents to mimic the characteristics of the herbal formulation. The mouthwash is supplied as a ready-to-use aqueous solution. It is administered as 10 mL per use, held in the oral cavity for 2-3 minutes, six times d

Primary outcome measures

• 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)]

Secondary outcome measures (4)

• Time to Onset of Radiation-Induced Oral Mucositis [Time frame: 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 [Time frame: 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 [Time frame: 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) [Time frame: 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.]

Eligibility criteria

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 1.
• 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.
• Willing and able to adhere to scheduled visits, treatment plans, laboratory tests, and other study procedures.

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07543978 · RTOM-1

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗