Evaluating Chinese Medicine Oral Rinse for Irradiated Oral Mucositis in Head & Neck Cancer Patients
Head and Neck Neoplasms, Oral Mucositis (Ulcerative) Due to Radiation, Chinese Medicine Oral Rinse
About this trial
This is an interventional treatment trial for Head and Neck Neoplasms
Eligibility Criteria
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.
Sites / Locations
- Hong Kong Institute of Integrative Medicine
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Intervention Group: Chinese Medicine Oral Rinse and Standard Care
Control Group: Placebo and Standard Care
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.
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.