Phase IB-II clinical trial of melatonin oral gel for the prevention and treatment of oral mucositis in patients with head and neck cancer undergoing chemoradiation.

Phase 1

• Conditions: Oral mucositis in patients with head and neck cancer undergoing chemoradiation; MedDRA version: 18.0Level: PTClassification code 10037763Term: Radiation mucositisSystem Organ Class: 10022117 - Injury, poisoning and procedural complications; Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]

• Registration Number: EUCTR2015-001534-13-ES
• Lead Sponsor: SPHERIUM BIOMED S.L.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07-10
• Last Update Posted: 22 January 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 84

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:
ooral cavity
ooropharynx or
oany 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):
oHaematology:
Absolute neutrophil count (ANC) ?1.5 x 109/L
Haemoglobin ? 10 g/dL
Platelets ? 100,000 x 109/L
oHepatic:
Total bilirubin ? 2 X (Upper limit normal) ULN
Alanine amino transferase (ALT) and Asparatate aminotransferase (AST) ?5 x ULN
oRenal:
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 <2.0 mg/dl.
oNutritional and metabolic:
Albumin > 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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified