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

Korábbi kezelés

• 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

Más betegség

• 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.

Laborértékek

• 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)

Egyéb

• 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

• 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