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Completed

NCT Number: NCT02885376

Study of Dentoxol® Mouthrinse for Oral Mucositis

The primary objective of this study is to determine the efficacy of Dentoxol® mouthrinse in reducing the severity of oral mucositis secondary to radiation therapy for head and neck cancer.

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Key information

Conditions

Oral Mucositis Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Mouth Diseases Mucositis Stomatitis Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Clinica IRAM, Santiago, Chile

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Planned to receive radiation therapy for cancer of the oral cavity, oropharynx, nasopharynx, hypopharynx or larynx, with or without concomitant chemotherapy.
  • Planned to receive at least 5000cGy radiation therapy to at least 2 of 12 pre-specified areas in the oral cavity

Exclusion criteria

  • Unable to give written informed consent
  • Known allergy/intolerance to any component of the study rinse or placebo
  • Planning to use any contraindicated medications during the study period (pain medications are allowed)
  • Age below 18 years
  • Pregnant or nursing (If the patient is a woman of childbearing potential, a pregnancy test must be performed within fourteen days before enrollment in the study)

Treatment and study plan

Dentoxol

Device

Mouthrinse

PLACEBO

Device

Mouthrinse

Primary outcomes

  1. Incidence of severe oral mucositis, defined as grade 3 or 4 on the World Health Organization (WHO) scale

    Time frame: First day of radiation therapy through last day of radiation therapy (5-8 weeks)

Secondary outcomes

  1. Duration of and time to onset of severe oral mucositis, defined as grade 3 or 4 on the World Health Organization (WHO) scale.

    Time frame: First day of radiation therapy through last day of radiation therapy (5-8 weeks)

  2. Mouth pain scores, as measured in the Oral Mucositis Daily Questionnaire (OMDQ).

    Time frame: First day of radiation therapy through last day of radiation therapy (5-8 weeks)

  3. Ability to eat, drink, and swallow, as measured in the Oral Mucositis Daily Questionnaire (OMDQ).

    Time frame: First day of radiation therapy through last day of radiation therapy (5-8 weeks)

  4. Weight loss, as measured by the difference between weight on first and last day of radiation therapy.

    Time frame: First day of radiation therapy through last day of radiation therapy (5-8 weeks)

  5. Use of opioid analgesics for oral mucositis pain, as expressed in morphine equivalents.

    Time frame: First day of radiation therapy through last day of radiation therapy (5-8 weeks)

Sponsors and collaborators

Lead sponsor

Ingalfarma SpA

Industry

Registry information

Official study title

Phase II Study of Dentoxol® Mouthrinse for Oral Mucositis Secondary to Radiation Therapy for Head and Neck Cancer

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Aug 31, 2016
Registry last updated
Dec 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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