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New treatment option for Oral Mucositis
Official title 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.
ClinicalTrials.gov ID: NCT05635929
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Acute Phase
- Patients diagnosed with Head \& Neck cancer who will undergo radiotherapy (with or without concomitant chemotherapy)
- Patients who are able to read, understand, and complete the questionnaire.
- Patients over 18 years of age. Chronic Phase
- Patients who have completed radiotherapy treatment at least 6 months before study enrollement.
You likely can't join if
- Acute Phase
- Patients who are unable to properly use the products.
- Patients who do not consent to participate in the study.
- Patients who were being treated for another type of cancer. Chronic Phase
- Patients using medications such as pilocarpine, cevimeline, etc., to treat xerostomia.
- Patients who do not consent to participate in the study.
See the full eligibility criteria
- Acute Phase
- Patients diagnosed with Head \& Neck cancer who will undergo radiotherapy (with or without concomitant chemotherapy)
- Patients who are able to read, understand, and complete the questionnaire.
- Patients over 18 years of age. Chronic Phase
- Patients who have completed radiotherapy treatment at least 6 months before study enrollement.
- Patients who are able to read, understand, and complete the questionnaire.
- Patients over 18 years of age.
- Acute Phase
- Patients who are unable to properly use the products.
- Patients who do not consent to participate in the study.
- Patients who were being treated for another type of cancer. Chronic Phase
- Patients using medications such as pilocarpine, cevimeline, etc., to treat xerostomia.
- Patients who do not consent to participate in the study.
The study team makes the final eligibility decision.
Where it's taking place
- Madrid, Madrid, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Madrid, Madrid, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.