Safety and Efficacy Trial of TV5M01 for Radiation-Induced Mucositis in Head and Neck Cancer Patients.

Launched by FUNDACION CLINICA VALLE DEL LILI · Mar 7, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called TV5M01, which is a gel made from green tea and morphine, to help patients with head and neck cancer who experience painful mouth sores caused by radiation therapy. The trial aims to compare this new gel to a standard mouthwash treatment to see which one works better and is safer for patients. It will involve 40 patients who are undergoing radiation treatment and have developed sores that are at least mild in severity.

To be eligible, participants need to be adults aged 18 to 60 with certain types of head and neck cancer, scheduled to start radiation therapy, and able to swallow liquids and solids. They will apply the gel or mouthwash three times a day until their sores improve. Throughout the trial, researchers will monitor participants closely for any side effects and how well the treatments work, focusing on pain levels and overall quality of life. This trial is an important step in finding better ways to manage a common and painful side effect of cancer treatment, potentially helping patients complete their radiation therapy more comfortably.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • Patients not eligible for radiotherapy
• • Stomatological disease such as ulcers, edema, exudation in the oropharyngeal mucosa before radiotherapy
• • Women who are pregnant or breastfeeding
• • Patients allergic or sensitive to any of the compounds in the gel or study medications
• • Presence of lesions that completely occlude the upper digestive tract
• • Patients with a history of disorders, specifically those with psychotic psychiatric disorders such as schizophrenia, schizoaffective disorder, and delusional disorder, and substance/alcohol abuse
• • Patients participating or who have participated in another clinical trial in the last 30 days
• • 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
• • Any evidence of oral infection or disease in the oral cavity other than HNSCC
• • 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)
• • Concomitant therapy with drugs that inhibit or enhance opioid action
• • 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.