Clinical trial · Interventional
Evaluating Chinese Medicine Oral Rinse for Irradiated Oral Mucositis in Head & Neck Cancer Patients
Evaluating Efficacy and Safety of Chinese Medicine Oral Rinse in Treating and Preventing Irradiated Oral Mucositis in Head-and-Neck Cancer Patients - a Pilot Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Approximately 60% and 90% of patients with head and neck (H\&N) cancers receiving standard radiotherapy (RT) and chemoradiotherapy (chemo-RT) will develop oral mucositis respectively. Oral mucositis (OM) is one of the dose-limiting adverse events which can also lead to emotional and nutritional problems. Clinically, it is usually observed by the end of first week of RT (after 10 Gy) and reaches peak damage in 14-21 days or by the end of treatment. Healing then takes approximately 2 to 3 weeks after completion of RT. For the Chinese Medicine (CM) interventions, many studies have been reviewed on the efficacy of mouthwash or internal herbal decoction to OM. Although some positive results were observed, most of them were performed by applying different assessment tools and lack of quality of life (QOL) or self-reported symptoms assessment. In addition, the intervention time and follow-up period were usually insufficient (stopped at the end of RT), therefore they could not review the long-term efficacy of CM according to normal progression of OM and the safety of using CM. Therefore, we hope this pilot study can evaluate the efficacy and safety of CM in a strict protocol.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chinese Medicine Oral Rinse | — | UNRESOLVED | — |
| Head and Neck Neoplasms | Head and Neck Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Oral Mucositis (Ulcerative) Due to Radiation | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chinese Medicine Oral Rinse Formula-I (CMORF-I) | Drug | — | UNRESOLVED |
| Placebo | Other | — | UNRESOLVED |
| Standard Care | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Intervention Group: Chinese Medicine Oral Rinse and Standard Care
- description
- * Prescription and oral rinsing with Chinese Medicine Oral Rinse Formula-I (CMORF-I) which mainly consists of the Nong's concentrated CM granules of Wu Wei Xiao Du Yin and other ingredients. * Standard care will be following the indications provided by patient's western medical doctor. * Patients should not take any other TCM and non-prescribed medication and nutritional supplements during the intervention period.
- interventionNames
- Drug: Chinese Medicine Oral Rinse Formula-I (CMORF-I)
- Other: Standard Care
- type
- PLACEBO_COMPARATOR
- label
- Control Group: Placebo and Standard Care
- description
- * Placebo: The placebo consists of an inert substance, made of starch filler, flavor and colorings. It is also manufactured under GMP standard. To ensure blinding, the CMORF-I formula and placebo will be indistinguishable in appearance, smell and favour. * Standard care will be following the indications provided by patient's western medical doctor. * Patients should not take any other TCM and non-prescribed medication and nutritional supplements during the intervention period.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Patients who * are aged ≥18, with known diagnosis of non-metastatic hypopharyngeal cancer, laryngeal cancer, lip and oral cavity cancer, nasopharyngeal cancer, oropharyngeal cancer, paranasal sinus and nasal cavity cancer, and salivary gland cancer. * are the first time to receive RT to the primary tumor in the area of the head or face, neck, or oral cavity. * start RT recently within 14 days. * are assessed by CMPs for the condition of oral mucositis according to modified World Health Organization (WHO) Mucositis Grades with Grade ≦1. * have Karnofsky Performance Status (KPS) ≥ 60 (patients require occasional assistance, but is able to care for most personal needs will be 60 or above). * are able to read or understand and sign the consent form. Exclusion Criteria: Patients who * receive concurrent chemo-radiation. * have known medication on bacterial or fungal infections of oropharynx at recruitment. * have other known diseases such as serious and uncontrolled Diabetes mellitus (with symptom of delayed wound healing over the past half year) or hyperthyroidism (with symptom of serious oral dryness over the past half year), known connective vascular disorders or known Human Immunodeficiency Virus (HIV) infections etc. * have known history of allergy to CMORF-I ingredients or Glucose-6-Phosphate Dehydrogenase (G6PD) patients. * are known pregnant or breastfeeding.
References
Publications (53)
- BACKGROUNDWorld Health Organization. WHO Handbook for Reporting the Results of Cancer Treatment. Geneva: WHO Offset Publications, 1979; 48:15-22
- BACKGROUNDNational Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE 4.03) from: https://ctep.cancer.gov/protocolDevelopment/adverse_effects.htm
- BACKGROUNDChinese Pharmacopoeia Commission. Pharmacopoeia of the People's Republic of China (English Edition) Vol. 1. Beijing, China: China Medical Science Press; 2015.
- RESULTSutherland SE, Browman GP. Prophylaxis of oral mucositis in irradiated head-and-neck cancer patients: a proposed classification scheme of interventions and meta-analysis of randomized controlled trials. Int J Radiat Oncol Biol Phys. 2001 Mar 15;49(4):917-30. doi: 10.1016/s0360-3016(00)01456-5. PMID 11240232
- RESULTLichtman SM. Physiological aspects of aging. Implications for the treatment of cancer. Drugs Aging. 1995 Sep;7(3):212-25. doi: 10.2165/00002512-199507030-00006. PMID 8535051
- RESULTPs SK, Balan A, Sankar A, Bose T. Radiation induced oral mucositis. Indian J Palliat Care. 2009 Jul;15(2):95-102. doi: 10.4103/0973-1075.58452. PMID 20668585
- RESULTLuo DH, Hong MH, Guo L, Cao KJ, Deng MQ, Mo HY. [Analysis of oral mucositis risk factors during radiotherapy for nasopharyngeal carcinoma patients and establishment of a discriminant model]. Ai Zheng. 2005 Jul;24(7):850-4. Chinese. PMID 16004814
- RESULTSaito N, Imai Y, Muto T, Sairenchi T. Low body mass index as a risk factor of moderate to severe oral mucositis in oral cancer patients with radiotherapy. Support Care Cancer. 2012 Dec;20(12):3373-7. doi: 10.1007/s00520-012-1620-7. Epub 2012 Oct 7. PMID 23052923
- RESULTElad S, Cheng KKF, Lalla RV, Yarom N, Hong C, Logan RM, Bowen J, Gibson R, Saunders DP, Zadik Y, Ariyawardana A, Correa ME, Ranna V, Bossi P; Mucositis Guidelines Leadership Group of the Multinational Association of Supportive Care in Cancer and International Society of Oral Oncology (MASCC/ISOO). MASCC/ISOO clinical practice guidelines for the management of mucositis secondary to cancer therapy. Cancer. 2020 Oct 1;126(19):4423-4431. doi: 10.1002/cncr.33100. Epub 2020 Jul 28.