Chemotherapeutic Toxicity, Head and Neck Cancer, Mucositis, Oral Mucositis, Pain, Quality of Life, Radiation Toxicity, Saliva, Speech
Conditions
Keywords
Oral Mucositis, Cancer Therapy Toxic Effect, Cancer Support, Pain, Ulcers, Treatment Interruptions, Oral Mucosa, Radiotherapy, Chemotherapy, Head and Neck Cancer, Severe Oral Mucositis
Brief summary
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.
Detailed description
This study analyses the severity of oral mucositis in 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 in H&N cancer patients 6 months after cancer treatment is completed. Quality of life of patients is analyzed before (baseline) and after 1 month period of use of the tested composition beginning 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 PROMS 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 novel composition comprising XCM-OM118 delivered in the form of a topical non-rinsing gel and a mouthwash. During Phase 1, patients apply two pumps of the gel before bedtime, mid-morning, and mid-afternoon, as well as before and after each therapy session. Six months after oncological treatment (Phase 2), patients will complete a questionnaire to assess their quality of life before implementing the oral care protocol (baseline). After 1-month intervention, patients will complete a final questionnaire. This intervention will consist of applying two pumps of the gel before bedtime, mid-morning, and mid-afternoon. Patients will rinse with the mouthwash three times a day, ideally after brushing. Adverse effects, such as allergic reaction, skin and/or mucosa irritation, itching, discomfort, yeast infection, or any other, will be collected and if so, a detailed description and follow-up of the problem will be noted.
Interventions
OTHERXCM-OM118 Composition comprising olive oil, betaine and xylitol
Topical composition in the form of a gel and a mouthwash.
Sponsors
Mucosa Innovations, S.L.
HM Sanchinarro University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Masking description
Open Label
Intervention model description
Single group, interventional, open-label study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute-phase 1: Frequency of severe oral mucositis (grades 3-4) in Head & Neck radiated patients (with or without concomitant chemotherapy) using a novel topical composition assessed objectively by the clinician | Six weeks during radiotherapy. | Frequency of severe oral mucositis (grades 3-4) measured with the World Health Organization (WHO) mucositis scale, assessed at weekly intervals during 6 weeks of radiotherapy. Oral mucositis will be objectively assessed by clinician, based on observation of mucosa tissue damage, pain and difficulties in swallowing from grade 0 to 4, where grade 0 is the best health score and grade 4 is the worst health score. Precisely, grade 0 means no tissue injury nor pain nor difficulty in swallowing, grade 1 means presence of erythema, soreness but not difficulty in swallowing, grade 2 means presence of ulcers with or without erythema, moderate pain but able to eat solids, grade 3 means confluent ulceration with severe pain and not able to eat solids and grade 4 means deep ulcerations and/or necrotic injury, extreme pain and unable to eat solids/drink. Grades 3 and 4 are defined as severe oral mucositis (SOM). |
| Chronic-phase 2: Changes in long-term quality of life of radiated Head & Neck cancer patients (with or without concomitant chemotherapy) after 1 month of use of the tested composition. | One month of use of the tested product. | 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 will be 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, are scaled evenly from 0 (worst) to 100 (best) according to the hierarchy of response. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to onset of severe oral mucositis (grades 3-4) in Head & Neck radiated patients (with or without concomitant chemotherapy) using XCM-OM118, assessed both objectively by the clinician and subjectively reported by the patient. | Six weeks during radiotherapy. | Time to onset of severe oral mucositis (grades 3-4) determined through both objective clinical assessments and patient-reported subjective symptoms, along the 6 weeks of radiotherapy. |
| Comparison between physician's (objective) and patient's (subjective) perception of oral mucositis severity during treatment week by week. | Six weeks during radiotherapy. | WHO scale will be used by clinician to objectively assess oral mucositis (OM) based on physician's observation of mucosa tissue damage, pain and difficulties in swallowing (grade 0 to grade 4) along 6 weeks of radiotherapy (RT). Patient reported outcomes, regarding pain and difficulties in swallowing, from grade 0 (no pain, nor difficulty in swallowing), 1 (soreness but not difficulty in swallowing), 2 (moderate pain but able to eat solids), 3 (severe pain and not able to eat solids) to grade 4 (extreme pain and unable to oral diet), will be recovered during an interview at time of visit to the unit at weekly intervals along the 6 weeks of RT. Evaluation of possible differences between objective and subjective OM severity data will be performed by calculating the agreement proportion and the Spearman´s rho coefficient. |
Countries
Spain
Contacts
CONTACTJorge Rodríguez-Vilaboa
STUDY_CHAIRBeatriz Rodríguez-Vilaboa del Cura
Outcome results
None listed