NCT02630004

Brief Summary

The main purpose of this study is to assess the efficacy of melatonin oral gel compared to placebo in the prevention and treatment of oral mucositis in patients with head and neck cancer undergoing concurrent chemoradiation. Other objectives are to assess the Quality of Life (QoL), to evaluate the safety and tolerability and to assess the pharmacokinetic profile of melatonin oral gel administration, in all cases compared to placebo in patients with head and neck cancer and oral mucositis secondary to concurrent chemoradiation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Nov 2015

Typical duration for phase_1

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 3, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 15, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 22, 2017

Completed
Last Updated

March 1, 2018

Status Verified

February 1, 2018

Enrollment Period

2.1 years

First QC Date

December 3, 2015

Last Update Submit

February 28, 2018

Conditions

Oral Mucositis

Keywords

MucositisHead and Neck cancerChemoradiation

Outcome Measures

Primary Outcomes (1)

  • Number (percentage) of patients who develop severe oral mucositis (grade 3-4 according to the RTOG scale)

    up to 19-20 weeks

Secondary Outcomes (17)

  • Number (percentage) of patients who develop severe oral mucositis (grade 3-4 according to NCI-CTCAE)

    up to 19-20 weeks

  • Number of days with mucositis of any grade according to the RTOG scale

    up to 19-20 weeks

  • Number of days with grade 3-4 mucositis according to the RTOG scale

    up to 19-20 weeks

  • Time to onset of grade 3-4 mucositis according to the RTOG scale from starting systemic antineoplastic treatment

    up to 19-20 weeks

  • Change from baseline in EORTC QLQ-C30 and EORTC QLQ-H&N35 scores at 4w after RT start

    up to 4-5 weeks

  • +12 more secondary outcomes

Other Outcomes (13)

  • Change from baseline in oral pain intensity measured by VAS at different time points along the study.

    two times a week up to 19-20 weeks

  • Number (percentage) of patients who need minor or major opioids

    up to 19-20 weeks

  • Number (percentage) of patients who need special procedures on nutritional status (feeding tube, jejunostomy, gastrostomy)

    up to 19-20 weeks

  • +10 more other outcomes

Study Arms (2)

Melatonin

EXPERIMENTAL

Melatonin oral gel 3%

Drug: Melatonin oral gel 3%

Placebo

PLACEBO COMPARATOR

Placebo oral gel

Drug: Placebo oral gel

Interventions

Melatonin oral gel 3%DRUG
Melatonin
Placebo oral gelDRUG
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female patients 18 years or over.
  • Patients who gave written informed consent.
  • Life expectancy ≥ 3 months.
  • Subjects willing to comply with treatment and follow-up.
  • Histologically confirmed diagnosis of non-metastatic TNM-2010 stage III-IV squamous cell carcinoma of the following sites:
  • oral cavity
  • oropharynx
  • or any Head and Neck site with lymph nodes at cervical level II.
  • Or histologically confirmed carcinoma of the nasopharynx (differentiated squamous cell carcinoma or NonKeratinizing carcinoma or undifferentiated carcinoma) found eligible for chemoradiation with or without neoadjuvant chemotherapy.
  • 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 local 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.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1.
  • Adequate baseline organ function (hematologic, liver, renal, nutritional and metabolic):
  • Haematology:
  • Absolute neutrophil count (ANC) ≥1.5 x 109/L
  • Haemoglobin ≥ 10 g/dL
  • +10 more criteria

You may not qualify if:

  • Patients with blistering disease.
  • Patients who require feeding with either nasogastric tube, gastrostomy or jejunostomy at study entry
  • Patients whose radiotherapy treatment planned dose is lower than 66 Gy
  • Patients being receiving another investigational agent because of participation in another therapeutic trial
  • Patients treated with fluvoxamine, estrogens, cimetidine, 5- and 8 methoxypsoralen and/or carbamazepine
  • Active viral, bacterial or fungal infections of the mouth in the last 14 days (i.e. stomatitis related to herpes virus or candida)
  • Pregnancy or lactation
  • Known allergy to melatonin
  • Prior radiotherapy of the head and neck
  • Patients with a treatment plan consisting of chemoradiation followed by further chemotherapy
  • Patients with a diagnostics of a synchronic neoplasia except for non-melanoma skin cancer curable with local treatment or in situ cervix carcinoma
  • 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
  • Any other medical condition that would make the patient inappropiate for study participation according to the Investigator's judgement.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Institut Català d'Oncologia ICO Badalona

Badalona, Barcelona, 08916, Spain

Location

Institut Català d'Oncologia L'Hospitalet

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Hospital Clínico Universitario de Santiago

Santiago de Compostela, La Coruña, 15706, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, 08026, Spain

Location

Hospital Universitari de la Vall d'Hebron

Barcelona, 08035, Spain

Location

Institut Català d'Oncologia Girona

Girona, 17007, Spain

Location

Hospital San Carlos, Madrid

Madrid, 28040, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Hospital Universitario Virgen de la Victoria

Málaga, 29010, Spain

Location

Hospital Universitario Marqués de Valdecilla

Santander, 39008, Spain

Location

Hospital Miguel Servet

Zaragoza, 50009, Spain

Location

MeSH Terms

Conditions

StomatitisMucositisHead and Neck Neoplasms

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesNeoplasms by SiteNeoplasms

Study Officials

  • Alicia Lozano, MD

    Institut Català d'Oncologia L'Hospitalet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2015

First Posted

December 15, 2015

Study Start

November 1, 2015

Primary Completion

December 1, 2017

Study Completion

December 22, 2017

Last Updated

March 1, 2018

Record last verified: 2018-02

Locations

ES(11)