Clinical trial

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.

Name

02-2022

Description

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.

Trial arms

Trial start

2022-10-11

Estimated PCD

2023-06-28

Trial end

2023-09-11

Status

Completed

Treatment

Composition comprising olive oil, xylitol and betaine

Topical composition in the form of a gel.

Arms:

Acute group (Phase 1), Chronic group (Phase 2)

Size

Primary endpoint

Frequency of severe oral mucositis in Head & Neck radiated patients with or without chemotherapy.

Six weeks during radiotherapy.

Time to severe oral mucositis in Head & Neck radiated patients with or without chemotherapy.

Six weeks during radiotherapy.

Quality of life evaluation of radiotherapy, with or without chemotherapy, long-term symptoms (6 months) after 1 month of use of the tested composition in head & neck cancer patients.

One month of use of the tested product.

Eligibility criteria

Inclusion Criteria: * Patients with diagnose of Head \& Neck cancer that are going to receive cancer therapy (radio and/or chemotherapy). Exclusion Criteria: * Patients taking drugs for xerostomia.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single group, interventional, open-label study.', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Open Label'}}, 'enrollmentInfo': {'count': 65, 'type': 'ACTUAL'}}

Updated at

2024-01-23

1 organization

3 products

8 indications

Product

Olive oil + Xylitol + Betaine

Indication

Oral Mucositis

Indication

Quality of Life

Indication