Mucositis Cancer Mucositis Mouthwash Cancer Hemp
Conditions
Interventions
Mouthwash containing hemp extract,Mouthwash without containing hemp extract
Active Comparator Other,Placebo Comparator Other
Hemp mouthwash ,Placebo
Sponsors
The Royal Golden Jubilee Ph.D. Program
Eligibility
Sex/Gender
All
Age
25 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients diagnosed with solid tumors who require chemotherapy, chemotherapy combined with radiotherapy, or radiotherapy alone at Naresuan University Hospital. 2. Aged 25 years or older (as cannabis may affect brain development in individuals younger than 25). 3. Experiencing radiation-induced oral mucositis at a severity of Grade 2 to Grade 3, as per NCI CTCAE (Version 5.0). 4. No underlying conditions that could affect oral inflammation, such as diabetes, immunodeficiency, autoimmune diseases, or AIDS. 5. Mentally alert and able to communicate in Thai through listening and speaking. 6. Willing and voluntarily participating in the study, with signed informed consent before the trial begins. 7. Female participants of reproductive age must test negative on a urine pregnancy test and agree to use contraception during the study. 8. Male participants must agree to use contraception and refrain from donating sperm during the study. 9. Must not have used medical cannabis or hemp products within three weeks before enrolling in the study
Exclusion criteria
Exclusion criteria: 1. Patients with a history of allergic reactions to any compounds in the hemp extract mouthwash used in the study. 2. Patients receiving radiation therapy at a dose greater than 2 Gy per session and/or more than once per day. 3. Pregnant or breastfeeding individuals. Individuals who are ineligible for treatment with hemp or medical cannabis extracts, including: Pregnant or breastfeeding women. Individuals with a history of allergy to cannabis extracts. 4. Individuals with severe cardiovascular disease, including unstable cardio-pulmonary conditions such as angina, peripheral vascular disease, cerebrovascular disease, or arrhythmia. Individuals with liver disease, including cirrhosis or liver enzyme (AST, ALT) levels exceeding three times the upper normal limit. Individuals with severe kidney disease, including end-stage renal disease (ESRD). Individuals with psychiatric disorders such as schizophrenia, substance-induced psychosis, major depressive disorder, or bipolar disorder, particularly those with a history of psychosis, schizophrenia, or substance use disorder (e.g., alcohol, amphetamines, or cocaine). Individuals taking anticoagulant medications. 5. Patients with oral mucositis caused by fungal or viral infections. 6. Undergoing treatment with medications that have drug interactions with cannabis products, including: Antidepressants Anticonvulsants Antihistamines Sedative-hypnotic drugs Nonsteroidal anti-inflammatory drugs (NSAIDs)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Score of mucositis 6 visit National cancer institute common toxicities criteria for adverse events (NCI CTCAE) version 5.0 | — |
Secondary
| Measure | Time frame |
|---|---|
| Score of oral mucositis weekly 7 days/6 visits Oral mucositis weekly questionnaire | — |
Countries
Thailand
Contacts
Public ContactNawarad Gimiphan
Faculty of Pharmaceutical Sciences, Naresuan University
Outcome results
None listed