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

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

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).

Study Overview

• Status: Completed
• Conditions: Hematologic Disease
• Intervention / Treatment: Device: Caphosol; Drug: Bicarbonate de sodium

• Study Type: Interventional
• Enrollment (Actual): 92
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Nantes, France, 44200
    • Nantes Universty Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Caphosol	Device: Caphosol; The Caphosol ™ is a recently launched medical in France (2009). (source: laboratory EUSA Pharma ®) The product is an aqueous solution for mouthwash that comes in the form of a hyper-saturated mixture of calcium phosphate at neutral pH to reconstitute immediately before use. Each patient randomized to the treatment arms in the study will receive daily at least 4 (maximum 10) mouthwash Caphosol ™. The treatments are to begin preventive J1 to chemotherapy and continued until out of aplasia (ANC> 500/mm3), and / or mucositis grade 0.
Active Comparator: Référence; •Bicarbonate de sodium à 1.4% Biosedra Versylène® or PAROEX® :	Drug: Bicarbonate de sodium; Treatment of the early start on the day of conditioning and stop when the ANC> 500/mm3 and / or mucositis grade zero, provisional date of bone exceeded. Versylène: Method of administration: gargle made with a minute from 15 to 30 mL, 2-5 times a day, alternating with PAROEX ®.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
assess the cost-effectiveness ratio is the number of days with severe mucositis won.	up to 28 days

Secondary Outcome Measures

Outcome Measure	Time Frame
The number of days without medication morphine won	up to 28 days
Aggregate saving medicines prescribed Supportive	up to 28 days
The incidence of mucositis	up to 28 days
The intensity of pain assessed with a visual analogue scale	up to 28 days
The cumulative dose of morphine administered and the number of days of treatment,	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 incidence of total parenteral nutrition	up to 28 days
- The duration of Release aplasia (ANC> 500/mm3),	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 severity of mucositis	up to 28 days
The duration of pain assessed with a visual analogue scale,	up to 28 days

Collaborators and Investigators

• Sponsor: Nantes University Hospital
• Collaborators: Jazz Pharmaceuticals
• Investigators: Principal Investigator: Thomas Gastinne, M D, Nantes university hospital

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: August 26, 2011
• First Submitted That Met QC Criteria: August 30, 2011
• First Posted (Estimate): August 31, 2011

Study Record Updates

• Last Update Posted (Estimate): May 3, 2016
• Last Update Submitted That Met QC Criteria: May 2, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: hematologic disease candidates for autologous or allogeneic bone marrow
• Additional Relevant MeSH Terms: Hematologic Diseases
• Other Study ID Numbers: BRD/10/06-C