Pharmaco-economic Study of a New Medical Device Performed From the Perspective of the Hospital

Phase 2

Completed

• Conditions: Hematologic Disease
• Interventions: Drug: Bicarbonate de sodium; Device: Caphosol

• Registration Number: NCT01426295
• Lead Sponsor: Nantes University Hospital

Brief Summary

The purpose of the study is to determine whether the use of mouthwashes Caphosol ™ in addition to standard oral care (strategy A) is cost-effective in the prevention and treatment of severe mucositis in adult patients with auto or allograft packaging without ICT versus mouthwashes standard bicarbonates with an antiseptic (strategy B).

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2011-08-26
• Study First Submitted QC: 2011-08-30
• Study First Posted: 2011-08-31
• Primary Completion: 2013-04
• Study Completion: 2014-04
• Status Verified: 2016-04
• Last Update Submitted: 2016-05-02
• Last Update Posted: 2016-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

Inclusion Criteria

• Patients > 18 years

Patient receiving:

• Conditioning of autologous bone marrow transplantation by high dose melphalan (HD) as part of the management of myeloma or BEAM in lymphoma.
• A conditioning allogeneic bone marrow transplantation with reduced or intermediate busulfan IV
• Patients belong to a schema of social security, having signed the written informed consent.

Exclusion Criteria

• patients:
• To receive or have received KGF
• With previous history of RT with the exception of patients who received spinal analgesic therapy in the treatment of myeloma
• Unable or unwilling to complete the self assessment questionnaire
• With previous history of allergy to any component of the products under consideration
• Minor
• Adults under guardianship
• Pregnant women
• Patients who have not signed the consent form
• Creation of mouthwash out of the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Référence	Bicarbonate de sodium	•Bicarbonate de sodium à 1.4% Biosedra Versylène® or PAROEX® :
Caphosol	Caphosol	-

Primary Outcome Measures

Name	Time	Method
assess the cost-effectiveness ratio is the number of days with severe mucositis won.	up to 28 days

Secondary Outcome Measures

Name	Time	Method
Aggregate saving medicines prescribed Supportive	up to 28 days
The intensity of pain assessed with a visual analogue scale	up to 28 days
- The duration of Release aplasia (ANC> 500/mm3),	up to 28 days
The severity of mucositis	up to 28 days
The duration of febrile neutropenia	up to 28 days
- The incidence and duration of treatment of anti-infective and antifungal	28 jours
The number of days without medication morphine won	up to 28 days
The duration of the hospitalization	participants will be followed for the duration of hospital stay, an expected average of 28 days
The incidence of mucositis	up to 28 days
The cumulative dose of morphine administered and the number of days of treatment,	28 days
The incidence of total parenteral nutrition	up to 28 days
The duration of pain assessed with a visual analogue scale,	up to 28 days

Trial Locations

Locations (1)

Nantes Universty Hospital; 🇫🇷 Nantes, France