Use of Questionnaires and a Mucosa Topical Composition on Oncological Patients.
Study Details
Study Description
Brief Summary
PROMs questionnaires seem to be an effective tool to obtain a greater knowledge of the physical and emotional state of patients. However, despite the disparity between physicians and patients perception, few studies have been performed with PROMs in H&N patients during and after treatment. The use of a topical mucosa care natural composition is studied along the use of PROMs.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
This study analyzes the Quality of life of H&N patients during treatment and after 6 months once treatment has finished.
During treatment (acute phase), mucositis may affect the quality of life of patients, while after treatment (chronic phase) xerostomia, dysphagia and speech limitations between others are behind anxiety and poor.
A PROMs questionnaire validated by Kushner et al, has been selected to measure the affectation during the acute phase, while a PROMs validated in the University of Washington by Nazar et al, has been chosen for the chronic phase evaluation.
Oral mucosa care will be homogenized both during the acute and the chronic phase with the use of a topical natural composition (Saliactive® which comprises olive oil, betaine and xylitol) in the form of a topic gel and a mouthwash.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Group of patients Patients recruited for the study |
Combination Product: Mouthrinse comprising olive oil, xylitol and betaine and an Oral topical gel comprising olive oil, xylitol and betaine.
Oral care regime to homogenize the group
|
Outcome Measures
Primary Outcome Measures
- Symptoms [Six weeks.]
Comparison of symptoms reported by patient throughout the Patient-Reported Oral Mucositis Symptom scale and symptoms observed by the medical team. The chosen questionnaire consists on a Visual Analog Scale rated from 0 to 100 were higher scores mean a worse outcome.
- Comparison of quality of life perception by the patient and the physician. [Six months after treatment.]
Comparison of symptoms reported by patient throughout the Spanish version of the University of Washington Quality of Life questionnaire and symptoms observed by the medical team. Each question offers several possible answers were higher scores mean a worse outcome.
Secondary Outcome Measures
- To assess the quality of life affectation during treatment. [Six weeks.]
Number of participants with treatment-related adverse events as assessed by PROMS scale, change from baseline in Oral Mucositis symptoms at 6 weeks.
- To assess what domains of quality of life were more affected. [Six months after treatment.]
Number of participants improvement as assessed by UW-QOL, change from baseline in quality of life at 1 month.
Eligibility Criteria
Criteria
Inclusion Criteria:
- Patients with diagnose of Head & Neck cancer that are going to be treated with radiotherapy.
Exclusion Criteria:
- Patients taken drugs for xerostomia.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mucosa Innovations S.L. | Madrid | Spain | 28023 |
Sponsors and Collaborators
- Mucosa Innovations, S.L.
Investigators
- Study Chair: Beatriz RodrÃguez-Vilaboa del Cura,
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 02-2022