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Olive

Patients 6 months after oncological treatment is finished

Topical composition in the form of a gel.

Composition comprising olive oil, xylitol and betaine

Beatriz Rodríguez-Vilaboa del Cura

PROMs questionnaires seem to be an effective tool to obtain a greater knowledge of the physical and emotional state of patients. Despite this, few studies have been performed using patient reported outcomes in Head \& Neck (H\&N) cancer patients during and after treatment. The use of a novel topical mucosa composition (Saliactive®) is studied along the use of questionnaires.

This study analyses the severity of oral mucositis of H\&N cancer patients along the first 6 weeks of radiotherapy with or without chemotherapy (Phase 1).

Phase 2 evaluates Quality of Life in a pool of H\&N cancer patients 6 months after cancer treatment is completed. Quality of life of patients is analysed before (baseline) and after 1 month period of use of the tested composition (Saliactive®) begining 6 months after oncological treatment completion.

During cancer treatment (Phase 1), mucositis may affect the course of therapy and long-term survival, while after treatment (Phase 2) chronic pain, xerostomia, dysphagia and speech limitations between others are behind anxiety and poor quality of life.

The WHO oral mucositis scale together with a structured qualitative questionnaire to recover patient reported symptoms are used during phase 1.

A validated Quality of Life questionnaire described by the University of Washington, is chosen for Phase 2 evaluation.

Oral mucosa management is homogenized both during acute and chronic phase with the use of a composition (Saliactive®) which comprises olive oil, betaine and xylitol delivered in the form of a topical non-rinsing gel.

Single group, interventional, open-label study.

Oral Mucositis and Quality of Life With a Mucosa Topical Composition in Head & Neck Cancer Patients.

Use of PROMs in Conjunction With a Mucosa Topical Composition to Evaluate Oral Mucositis During Cancer Treatment and Post-treatment QoL in H&N Cancer Patients. An Interventional Two Phases Study, Part of the Stop Mucositis Project.

Frequency of severe oral mucositis (grades 3-4) measured with the WHO scale during the 6 weeks of radiotherapy.

Oral mucositis was objectively assessed by clinician, based on observation of mucosa tissue damage, from grade 0 (no tissue injury), grade 1 (presence of erythema), grade 2 (presence of ulcers with or without erythema), grade 3 (confluent ulceration) to grade 4 (deep ulcerations and/or necrotic injury) at weekly intervals along the 6 weeks of radiotherapy.

Subjective assessment was also measured from patient reported outcomes regarding pain and difficulties in swallowing, from grade 0 (no pain, nor difficulty in swallowing), grade 1 (soreness but not difficulty in swallowing), grade 2 (moderate pain but able to eat solids), grade 3 (severe pain and not able to eat solids) to grade 4 (extreme pain and unable to oral diet) at the same time as the clinician measurement.

Frequency of severe oral mucositis (grades 3-4) were analysed at the end of the treatment.

Time to severe oral mucositis (grades 3-4) was analysed from clinically objective data and also from patient reported subjective symptoms registered week per week.

Comparison of late symptoms perceived by the patient through the PROMs validated Spanish version of the University of Washington Quality of Life questionnaire (UW-QOL) before (baseline) and after 1 month using the tested composition, starting 6 months after radiotherapy completion.

The UW-QOL questionnaire was filled by patients at baseline and after 1 month of use of the tested composition where the possible response options (from 3 to 6) to the 12 single question domains, were scaled evenly from 0 (worst) to 100 (best) according to the hierarchy of response.

The WHO scale was used by clinician to objectively assess oral mucositis grade based on physician's observation of mucosa tissue damage along the 6 weeks of radiotherapy. Oral mucositis severity was graded from grade 0 (no tissue injury), grade 1 (presence of erythema), grade 2 (presence of ulcers with or without erythema), grade 3 (confluent ulceration) to grade 4 (deep ulcerations and/or necrotic injury). Patient reported outcomes, regarding pain and difficulties in swallowing, from grade 0 (no pain, nor difficulty in swallowing), grade 1 (soreness but not difficulty in swallowing), grade 2 (moderate pain but able to eat solids), grade 3 (severe pain and not able to eat solids) to grade 4 (extreme pain and unable to oral diet), were recovered during an interview at time of visit to the unit at weekly intervals along the 6 weeks of radiotherapy.

Evaluation of possible differences between objective and subjective data was performed.

Frequency of severe oral mucositis (grades 3-4) were to be assessed in patients receiving radiotherapy and patients receiving al chemotherapy.

Evaluation of possible differences between patients receiving radiotherapy and patients receiving also chemotherapy data was performed.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Oral Mucositis and Quality of Life With a Mucosa Topical Composition in Head & Neck Cancer Patients.	NCT05635929	Oral Mucositis Quality of Life Mucositis Pain Speech Saliva Radiation Toxic... Chemotherapeuti...	Composition com...	18 Years -	Mucosa Innovations, S.L.
Oral Mucositis and Quality of Life With a Mucosa Topical Composition in Head & Neck Cancer Patients.	NCT05635929	Oral Mucositis Quality of Life Mucositis Pain Speech Saliva Radiation Toxic... Chemotherapeuti...	Composition com...	18 Years -	Mucosa Innovations, S.L.
Oral Mucositis and Quality of Life With a Mucosa Topical Composition in Head & Neck Cancer Patients.	NCT05635929	Oral Mucositis Quality of Life Mucositis Pain Speech Saliva Radiation Toxic... Chemotherapeuti...	Composition com...	18 Years -	Mucosa Innovations, S.L.

Spots Global Cancer Trial Database for composition comprising olive oil, xylitol and betaine