GUM Hydral Mouthwash vs Placebo in the Management of Hyposalivation.

NCT05103124 | Completed

• 1 other identifier: SSHNC-1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

There is currently little robust evidence to inform the management of hyposalivation and xerostomia in this population. Although the treatment of xerostomia is very individual, a first-line medication is needed to ameliorate the dehydration in the mouth by substituting for the secretion of saliva. The aim of this study is to describe the effect of the administration of Hydral on reducing patients' xerostomia symptoms due to radiotherapy. The study will be conducted as a double-blind randomized clinical trial (RCT) and foresees a crossover design, so the population will be divided into two groups, receiving both the medical device and the placebo.

Conditions

Xerostomia; Xerostomia Following Radiotherapy

Outcome Measures

Primary Outcomes (1)

• Improvement of the Xerostomia Questionnaire (XQ)

  The modified XQ provides a measure of the severity of radiation -induced xerostomia that affects the patients' QoL. This questionnaire consists of 10 questions, associated with patient-reported dryness. Moreover, a general question "how dry is your mouth?" has been added to the questionnaire. The modified XQ is a self-administered tool and patients will be asked to rate each symptom on a 10-point NRS scale of 0-10, with higher scores indicating more severe dryness or discomfort due to dryness. Each item score is added, and the sum is linearly transformed to produce the final summary score ranging from 0 to 100, with higher scores representing higher levels of xerostomia.

  After a one-month therapy both with Hydral and Placebo

Secondary Outcomes (2)

• Improvement of the EORTC QLQ-30 questionnaire

  After a one-month therapy both with Hydral and Placebo

• Improvement of the EORTC QLQ_H&N-35 Questionnaire

  After a one-month therapy both with Hydral and Placebo

Study Arms (2)

Hydral

EXPERIMENTAL

The participants will be asked to rinse their mouth five times a day with the experimental product. After one month, the administration will be stopped and the patients will be asked to fulfill the questionnaires mentioned in the methods section (XQ, QLQ-C30, QLQ HN35)

Device: Hydral; Other: Placebo

Placebo

PLACEBO COMPARATOR

The participants will be asked to rinse their mouth five times a day with the placebo comparator. After one month, the administration will be stopped and the patients will be asked to fulfill the questionnaires mentioned in the methods section (XQ, QLQ-C30, QLQ HN35)

Device: Hydral; Other: Placebo

Interventions

Hydral DEVICE

The investigational product GUM Hydral will be administered for a 30-days treatment period

Hydral; Placebo

Placebo OTHER

The placebo product will be administered for a 30-days treatment period

Hydral; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients willing to sign the informed consent form
• Patients older than 18 years
• Patients with diagnosis of HNC, who had received local radiotherapy at least three months before the beginning of the study, involving the salivary glands, both for curative and palliative purpose, with or without chemotherapic treatment, reporting xerostomia symptoms
• Patients with diagnosis of HNC, who had received local radiotherapy as an adjuvant to surgical resection at least three months before the beginning of the study, with or without chemotherapic treatment, reporting xerostomia symptoms-

You may not qualify if:

• Patients with documented contraindication to any of the components of GUM HYDRAL (there included eccipients)
• Patients with any neurological and psychiatric condition having an influence on the ability to self-apply the treatment
• Patients unwilling to complete the request diary card
• Patients unable to attend the ambulatory visits scheduled by the protocol
• Patients participating to other clinical studies
• Patients who had received antitumoral treatment during the previous three months
• Patients with concomitant Sjogren's syndrome
• Other causes of xerostomia (pharmacological treatment)

Sponsors & Collaborators

• Catholic University of the Sacred Heart: lead
• Sunstar Italiana SRL.: collaborator

Study Sites (1)

Catholic University of the Sacred Hearth

Roma, 00168, Italy

Location

Related Publications (1)

• Rupe C, Basco A, Gioco G, Patini R, Lucchese A, Micciche F, Massaccesi M, Lajolo C. Sodium-hyaluronate mouthwash on radiotherapy-induced xerostomia: a randomised clinical trial. Support Care Cancer. 2023 Oct 18;31(12):644. doi: 10.1007/s00520-023-08090-x.

  PMID: 37851095 DERIVED

MeSH Terms

Conditions

Xerostomia

Condition Hierarchy (Ancestors)

Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Carlo Lajolo, Prof.

  CU Sacred Hearth

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor and Principal Investigator

Study Record Dates

• First Submitted: October 17, 2021
• First Posted: November 2, 2021
• Study Start: November 3, 2020
• Primary Completion: December 31, 2021
• Study Completion: July 26, 2022
• Last Updated: July 28, 2022

Record last verified: 2022-07

Locations

IT (1)