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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02885376 |
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Date of registration:
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26/08/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Study of Dentoxol® Mouthrinse for Oral Mucositis
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Scientific title:
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Phase II Study of Dentoxol® Mouthrinse for Oral Mucositis Secondary to Radiation Therapy for Head and Neck Cancer |
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Date of first enrolment:
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November 2014 |
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Target sample size:
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108 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02885376 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 2
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Countries of recruitment
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Chile
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Contacts
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Name:
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Sebastián Sole |
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Address:
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Telephone:
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Email:
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Affiliation:
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Clinica IRAM |
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Key inclusion & exclusion criteria
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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)
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Oral Mucositis
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Intervention(s)
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Device: Placebo
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Device: Dentoxol
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Primary Outcome(s)
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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)]
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Secondary Outcome(s)
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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)]
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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)]
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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)]
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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)]
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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)]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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