Clinical trial NCT01426295: Pharmaco-economic Study of a New Medical Device Performed From the Perspective of the Hospital
Official title: Pharmaco-economic Cost-effective Prospective Randomized Trial Evaluating the Open Interest Caphosol ® Mouthwashes in the Prevention and Treatment of Severe Oral Mucositis in Patients Receiving High-dose Chemotherapy in Hematology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hematologic Disease
Keywords: hematologic disease candidates for autologous or allogeneic bone marrow
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
Collaborators: name: Jazz Pharmaceuticals
First posted: 2011-08-31
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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).


Eligibility criteria: 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

Primary outcomes:
measure: assess the cost-effectiveness ratio is the number of days with severe mucositis won.
timeFrame: up to 28 days
Secondary outcomes:
measure: The number of days without medication morphine won
timeFrame: up to 28 days
measure: Aggregate saving medicines prescribed Supportive
timeFrame: up to 28 days
measure: The incidence of mucositis
timeFrame: up to 28 days
measure: The intensity of pain assessed with a visual analogue scale
timeFrame: up to 28 days
measure: The cumulative dose of morphine administered and the number of days of treatment,
timeFrame: 28 days
measure: The duration of febrile neutropenia
timeFrame: up to 28 days
measure: - The incidence and duration of treatment of anti-infective and antifungal
timeFrame: 28 jours
measure: The incidence of total parenteral nutrition
timeFrame: up to 28 days
measure: - The duration of Release aplasia (ANC> 500/mm3),
timeFrame: up to 28 days
measure: The duration of the hospitalization
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 28 days
measure: The severity of mucositis
timeFrame: up to 28 days
measure: The duration of pain assessed with a visual analogue scale,
timeFrame: up to 28 days
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes Universty Hospital
Study officials:
affiliation: Nantes University Hospital
name: Thomas Gastinne, M D
role: PRINCIPAL_INVESTIGATOR
References: