NCT06875791Not yet recruitingPhase 1/2
Safety and Efficacy Trial of TV5M01 for Radiation-Induced Mucositis in Head and Neck Cancer Patients.
A Safety and Efficacy Trial of TV5M01 for Radiation-Induced Mucositis in Patients Undergoing Treatment for Head and Neck Cancer
Source: ClinicalTrials.gov · Last updated 1 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This study is a Phase 2, double-blind, randomized controlled trial evaluating the safety and efficacy of TV5M01 (a 5% green tea and 0.1% morphine gel) compared to triple mixture (0.19% lidocaine, 0.29% nystatin, and 5.50% hydroxides) for treating radiation-induced oral mucositis in patients with head and neck squamous cell carcinoma. The trial will enroll 40 patients (20 per group) with stage III-IV head and neck cancer receiving radiotherapy who develop grade 1 or higher mucositis. Participants will apply the assigned mouthwash three times daily from mucositis diagnosis until resolution. Primary outcomes include safety (incidence of infections and adverse events) and efficacy (duration of grade 3-4 mucositis, days with severe pain). Secondary outcomes include quality of life and analgesic use. Randomization will use minimization methodology to balance important prognostic factors. The study design incorporates two interim analyses after 10 and 19 participants, with clear safety monitoring and stopping rules. If successful, this trial could provide an evidence-based treatment option for radiotherapy-induced mucositis, potentially improving treatment completion rates and quality of life for head and neck cancer patients.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 7 Mar 2025
- Start date
- 28 Dec 2025
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Fundacion Clinica Valle del Lili
- Diseases
- Head and neck cancer
- NCT number
- NCT06875791
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 40
- From 28 Dec 2025 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients not eligible for radiotherapy
- Another uncontrollable, severe, hemodynamically unstable concurrent medical condition requiring urgent attention or threatening the patient's life
- Receiving chemotherapy regimens with delayed toxicity within the last 4 weeks (six weeks for nitrosourea or mitomycin C) or continuous or weekly chemotherapy regimen with limited potential for delayed toxicity within the last two weeks
- Concomitant therapy with drugs that inhibit or enhance opioid action
Other illness
- Stomatological disease such as ulcers, edema, exudation in the oropharyngeal mucosa before radiotherapy
- Patients allergic or sensitive to any of the compounds in the gel or study medications
- Patients with a history of disorders, specifically those with psychotic psychiatric disorders such as schizophrenia, schizoaffective disorder, and delusional disorder, and substance/alcohol abuse
- Any evidence of oral infection or disease in the oral cavity other than HNSCC
- Hypersensitivity to opioids, respiratory depression, obstructive airway disease, acute liver disease, seizure disorder, increased intracranial pressure, paralytic ileus, patients with known sensitivity to morphine, pheochromocytoma, acute asthma exacerbations, history of cardiac arrhythmia, heart failure.
Lab values
- Any important medical disease or incidental abnormal laboratory finding that could increase the participant's risk in the study (based on the investigator's judgment)
Other
- Women who are pregnant or breastfeeding
- Presence of lesions that completely occlude the upper digestive tract
- Patients participating or who have participated in another clinical trial in the last 30 days
Who the study is looking for
- Age ≥ 18 years and \< 60 years
- Diagnosis of HNSCC of the oral cavity, larynx, oro- and hypopharynx, diagnostic stage III-IV according to the AJCC 8th edition, scheduled to start radiotherapy
- Ability to swallow solids and liquids before starting radiotherapy treatment
- Adequate contraception for both sexes:
- For women: negative pregnancy test for women of childbearing age; must be surgically sterile, postmenopausal (defined as absence of menstrual cycle for at least 12 consecutive months), or comply with an acceptable contraceptive regimen during and 3 months after the treatment period
- For men: must be surgically sterile or comply with a contraceptive regimen during and for 3 months after the treatment period
- Performance status (ECOG) of 0-1, measured within 72 hours prior to treatment initiation
- Expected life expectancy ≥ 6 months
- Adequate renal function \[creatinine ≤ 1.5 times the upper limit of normal (ULN) or Glomerular Filtration Rate ≥ 50 ml/min\]
- Adequate liver function \[total bilirubin ≤ 1.5 x ULN; AST or ALT ≤ 3 x ULN or ≤ 5 x ULN if due to tumor liver involvement\]
- Provision of signed and dated informed consent before initiating any study-related procedure
- Meeting the diagnostic criteria for grade 1 or higher mucositis according to WHO classification
- Meeting the criteria for starting radiotherapy
- Willing and able to participate in the trial and comply with all trial requirements
Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fundación Valle del Lili Coordinator of this site? Confirm its status | Cali | Colombia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.