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Effect of a Novel Topical Composition on the Incidence of Severe Oral Mucositis in Head & Neck Cancer Radiated Patients and Quality of Life Assessed by PROMs.

Study acronym: STOPOMP
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Primary completion pushed from Jun 28, 2023 to Mar 2027
    • Study completion pushed from Jan 11, 2024 to Mar 2027
    • Trial status: Completed to Recruiting
    • Site details revised
    v9
  2. Interventions: XCM-OM118 Composition comprising olive oil, betaine and xylitol (Combination Product) to XCM-OM118 Composition comprising olive oil, betaine and xylitol (Other)
    • Study arms: 2 to 1
    • Study title shortened, about 1 word
    v8
  3. Primary endpoints: 3 to 2v7 Show 9 more changesShow less
    • Enrollment target: 65 to 63
    • Study completion date: Sep 11, 2023 to Jan 11, 2024
    • Interventions: Composition comprising olive oil, xylitol and betaine (Combination Product) to XCM-OM118 Composition comprising olive oil, betaine and xylitol (Combination Product)
    • Eligibility criteria expanded, about 98 words
    • Secondary endpoints: 3 to 2
    • Study description expanded, about 119 words
    • Site details revised
    • Study title expanded, about 11 words
    • Collaborators expanded, about 4 words
  4. Primary endpoints: 2 to 3v6 Show 4 more changesShow less
    • Secondary endpoints: 1 to 3
    • Publications: 4 to 3
    • Study title expanded, about 6 words
    • Study description shortened, about 3 words
  5. Primary endpoints revised (2)
    • Secondary endpoint revised
    • Study description shortened, about 29 words
    • Publications: 2 to 4
    v5
Show 3 earlier versionsHide 3 earlier versions
  1. Trial status: Recruiting to Completed
    • Study description shortened, about 9 words
    • Site details revised
    v4
  2. Study description expanded, about 65 wordsv3
  3. Primary endpoints revised (2)v2 Show 8 more changesShow less
    • Enrollment target: 60 to 65
    • Primary completion date: Feb 28, 2023 to Jun 28, 2023
    • Study completion date: May 11, 2023 to Sep 11, 2023
    • Interventions: Mouthrinse comprising olive oil, xylitol and betaine and an Oral topical gel comprising olive oil, xylitol and betaine. (Combination… to Composition comprising olive oil, xylitol and betaine (Combination Product)
    • Secondary endpoints: 2 to 1
    • Study description expanded, about 29 words
    • Study arms: 1 to 2
    • Eligibility criteria expanded, about 2 words
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The use of a novel topical mucosa composition (XCM-OM118) comprising 2-(trimethylazaniumyl) acetate; (2R,3R,4S)-pentane-1,2,3,4,5-pentol; Hexadecanoic acid; (9Z, 12Z)-octadeca-9,12-dienoic acid; octadecanoic acid; (Z)-hexadec-9-enoic acid; (Z)-octadec-9-enoic acid) delivered as a gel and a mouthwash is to be studied in regard to its effect on the incidence of severe oral mucositis in Head \& Neck cancer radiated patients. Patient reported outcome measures seem to be an effective tool to obtain a greater knowledge of the physical and emotional state of patients, being used in this study to assess quality of life of Head \& Neck cancer radiated patients.
Trial Details
NCT Number NCT05635929
Lead Sponsor Mucosa Innovations, S.L.
Collaborators: HM Sanchinarro University Hospital
Conditions
(from sponsor)		 Oral Mucositis, Quality of Life, Mucositis, Pain, Speech, Saliva, Radiation Toxicity, Chemotherapeutic Toxicity +1 more
Related terms Head and Neck Neoplasms, Mucositis, Pain, Radiation Injuries, Speech, Stomatitis, Ulcer
Enrollment 63 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov