RINSING WITH DESAMETASONE VERSUS RINSING WITH BENZIDAMINE IN THE PREVENTION OF MUCOSITES CORRELATED TO CHEMIORADIOTHERAPY IN PATIENTS WITH CANCERS OF THE CERVIC-FACIAL DISTRICT-Studio DEXWASH

RINSING WITH DESAMETASONE VERSUS RINSING WITH BENZIDAMINE IN THE PREVENTION OF MUCOSITES CORRELATED TO CHEMIORADIOTHERAPY IN PATIENTS WITH CANCERS OF THE CERVIC-FACIAL DISTRICT-Studio DEXWASH - DEXWASH Study

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-004078-89-IT

Enrollment

144

Registered

2021-06-04

Start date

Unknown

Completion date

Unknown

Last updated

2025-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

patients with cervico-facial neoplasms receiving concomitant chemoradiotherapy. MedDRA version: 20.0 Level: SOC Classification code 10029104 Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps) System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Trade Name: soldesam Product Name: soldesam Product Code: [019499072] Pharmaceutical Form: Oral drops, solution INN or Proposed INN: DESAMETASONE CAS Number: 2392-39-4 Current Sponsor code: 019499084

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Age over 18 years; • Histological diagnosis of cervico-facial cancer; • Clinical stage III or IV with indication of concomitant chemoradiotherapy with cisplatin (exclusive or post-surgery adjuvant); • Performance status 0-2 according to ECOG; • Adequate medullary crasis (hemoglobin> 10.0 g / dL, leukocytes> 3000 / µL, neutrophils> 1500 / µL, platelets > 100,000 / ul); • Proper renal and hepatic function; • Written informed consent according to the procedures of local Ethics Committees. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 120 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 24

Exclusion criteria

Exclusion criteria: • Presence of distant metastases • Previous radiotherapy treatment and / or chemotherapy; • Uncontrolled internal pathology; • Other anticancer therapies in progress; • Active immunological diseases; • Concomitant immunosuppressive therapy; • Presence of mucositis of the already active oral cavity.

Design outcomes

Primary

Measure	Time frame
Main Objective: The aim of the study is to test the efficacy of rinsings with dexamethasone versus rinsing with benzydamine in reducing the incidence of oral mucositis in patients with cervico-facial neoplasms receiving concomitant chemoradiotherapy.;Secondary Objective: 432/5000 • Need to resort to opioid analgesics during treatment (in morphine equivalents); • Resolution resolution of grade 3 and 4 mucositis at grade 2 in the 12 weeks following the beginning of the chemoradiotherapy treatment, according to the CTCAE criteria 4.03;Timepoint(s) of evaluation of this end point: 12 weeks	—

Measure

Time frame

Main Objective: The aim of the study is to test the efficacy of rinsings with dexamethasone versus rinsing with benzydamine in reducing the incidence of oral mucositis in patients with cervico-facial neoplasms receiving concomitant chemoradiotherapy.;Secondary Objective: 432/5000 • Need to resort to opioid analgesics during treatment (in morphine equivalents); • Resolution resolution of grade 3 and 4 mucositis at grade 2 in the 12 weeks following the beginning of the chemoradiotherapy treatment, according to the CTCAE criteria 4.03;Timepoint(s) of evaluation of this end point: 12 weeks

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Countries

Italy

Contacts

Public ContactCentro Data Management

AOU San Luigi

francesca.arizio@unito.it

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026