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

Nantes University Hospital (NUH)

Status and phase

Completed

Phase 2

Conditions

Hematologic Disease

Treatments

Device: Caphosol

Drug: Bicarbonate de sodium

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01426295

BRD/10/06-C

Details and patient eligibility

About

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).

Enrollment

92 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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