Oral mucositis in patients with head and neck cancer undergoing chemoradiation MedDRA version: 18.0 Level: PT Classification code 10037763 Term: Radiation mucositis System Organ Class: 10022117 - Injury, poisoning and procedural complications
Conditions
Interventions
Product Name: Melatonin oral gel 3%
Product Code: JAN13004
Pharmaceutical Form: Oral gel
INN or Proposed INN: Melatonin
CAS Number: 73-31-4
Current Sponsor code: JAN13004
Other descriptive name: MELAT
Sponsors
SPHERIUM BIOMED S.L.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Male and female patients 18 years or over. 2.Patients who gave written informed consent. 3.Life expectancy ? 3 months. 4.Histologically confirmed diagnosis of non-metastatic TNM-2010 stage III-IV squamous cell carcinoma of the following sites: o oral cavity o oropharynx or o any Head and Neck site with lymph nodes at cervical level II. 5.Histologically confirmed undifferentiated nasopharyngeal carcinoma. 6.Patients who have a treatment plan based on systemic treatment (cisplatin or cetuximab) concurrent with radiation with curative intent. Patients may have received up to 3 cycles of neoadjuvant chemotherapy if adverse events related to this treatment are fully resolved before study entry. Patients with a plan of postoperative chemoradiation may be included only if the primary tumour is located in the oral cavity. 7.Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1. 8.Adequate baseline organ function (hematologic, liver, renal, nutritional and metabolic): o Haematology: Absolute neutrophil count (ANC) ?1.5 x 109/L Haemoglobin ? 10 g/dL Platelets ? 100,000 x 109/L o Hepatic: Total bilirubin ? 2 X (Upper limit normal) ULN Alanine amino transferase (ALT) and Asparatate aminotransferase (AST) ?5 x ULN o Renal: For patients who will receive cisplatin: Serum creatinine ? ULN or, if > ULN calculated creatinine clearance (ClCR) ? 60 mL/min. For patients who will receive cetuximab: Serum creatinine 3.0 mg/dl Magnesium > lower limit normal (LLN) for patients who will receive cetuximab Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 67 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 17
Exclusion criteria
Exclusion criteria: 1.Patients with blistering disease. 2.Patients who require feeding with either nasogastric tube, gastrostomy or jejunostomy at study entry 3.Patients whose radiotherapy treatment planned dose is lower than 66 Gy 4.Patients being receiving another investigational agent because of participation in another therapeutic trial 5.Patients treated with fluvoxamine, estrogens, cimetidine, 5- and 8 methoxypsoralen and/or carbamazepine 6.Active viral, bacterial or fungal infections of the mouth in the last 14 days (i.e. stomatitis related to herpes virus or candida) 7.Pregnancy or lactation 8.Known allergy to melatonin 9.Prior radiotherapy of the head and neck 10.Patients with a treatment plan consisting of chemoradiation followed by further chemotherapy 11.Patients with a diagnostics of a synchronic neoplasia except for non-melanoma skin cancer curable with local treatment or in situ cervix carcinoma 12.Any investigational agent within 30 days prior to inclusion 13.Male or female of childbearing age who do not agree with taking adequate contraceptive precautions, i.e. use contraception double barrier (e.g. diaphragm plus condoms) or abstinence during the course of the study and for 2 months after the last administration of the study drug for women and 1 month for men 14.Psychological, geographical, familial or sociological conditions that potentially prevent compliance with the study protocol and follow-up schedule according to investigator criteria. These conditions should be discussed with the patient before inclusion in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of melatonin oral gel 3% mouthwashes compared to placebo in the prevention and treatment of oral mucositis in patients with neck and head cancer undergoing concurrent chemoradiation.;Secondary Objective: -To assess the Quality of Life (QoL) of melatonin oral gel 3% mouthwashes compared to placebo. -To evaluate the safety and tolerability of melatonin oral gel 3% mouthwashes in patients with head and neck cancer and oral mucositis secondary to concurrent chemoradiation, compared to placebo. -To assess the pharmacokinetic profile of melatonin gel 3% mouthwashes in patients with head and neck cancer and oral mucositis secondary to concurrent chemoradiation.;Primary end point(s): Number (percentage) of patients who develop severe oral mucositis (grade 3-4 according to the RTOG scale).;Timepoint(s) of evaluation of this end point: At screening/baseline, 2-3 days before starting radiotherapy or cetuximab, twice a week (in two non-consecutive days) during the 7 weeks of radiation, once a week during the period when patients continue to take IMP (after end of chemoradiotherapy) and at each monthly follow up visit after completion of radiotherapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Mucositis: At screening/baseline, 2-3 days before starting RT or cetuximab, twice a week (2 non-consecutive days) during the 7w of RT, once a week during the period when patients continue to take IMP (after end of QRT) and at each monthly fup visit. EORTC QLQ: 2-3 days before starting RT or cetuximab, 4w after RT start, 1w after completion of RT and at last fup visit. ECOG PS/VAS: At screening/baseline, 2-3d before starting RT or cetuximab, at day 0 (cetuximab patients), 7, 14, 21,28,35,42, at the end of RT, once a week during the period when patients continue to take IMP and at each monthly fup visit. Tumor response:baseline and 2 months after end of RT PK: 1st day of treatment,during 7w of RT, after RT completion while patients receive IMP, at last day of IMP treatment;Secondary end point(s): Efficacy: ? Number (percentage) of patients who develop severe oral mucositis (grade 3-4 according to NCI-CTCAE) ? Number of days with mucositis of any grade according to the RTOG scale ? Number of days with grade 3-4 mucositis according to the RTOG scale ? Time to onset of grade 3-4 mucositis according to the RTOG scale from starting systemic antineoplastic treatment Quality of Life: ? Change from baseline in EORTC QLQ-C30 and EORTC QLQ-H&N35 scores at 4 weeks after radiotherapy start, one week after completion of radiotherapy and at the last follow up visit (three months after completion of radiotherapy). ? Change from baseline in ECOG-Performance status score at different time points along the study. Safety: ? Number (percentage) of patients with grade 1-4 NCI-CTCAE adverse events related to IMP (melatonin oral gel 3%). ? Number (percentage) of patients who develop cisplatin or cetuximab-associated grade 1-4 adverse events according to the NCI-CTCAE scale. ? Number (percentage) of patients who develop radiation-associated adverse events different from oral mucositis according to the RTOG scale Pharmacokinetic | — |
Countries
Spain
Contacts
Public ContactAnna Colomé
Trial Form Support S.L.
Outcome results
None listed