"Pharmaco-economic Cost-effective Single-center 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 '
This study is currently recruiting participants.
Verified August 2011 by Nantes University Hospital
Sponsor:
Nantes University Hospital
Collaborator:
EUSA Pharma (US), Inc.
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01426295
First received: August 26, 2011
Last updated: August 30, 2011
Last verified: August 2011
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Hematologic Disease |
Device: Caphosol Drug: Bicarbonate de sodium |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label |
Resource links provided by NLM:
Further study details as provided by Nantes University Hospital:
Primary Outcome Measures:
- assess the cost-effectiveness ratio is the number of days with severe mucositis won. [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- The number of days without medication morphine won [ Time Frame: 28 days ] [ Designated as safety issue: No ]
- Aggregate saving medicines prescribed Supportive [ Time Frame: 28 days ] [ Designated as safety issue: No ]
- - The incidence and severity of mucositis [ Time Frame: 28 days ] [ Designated as safety issue: No ]
- The intensity and duration of pain assessed with a visual analogue scale, [ Time Frame: 28 days ] [ Designated as safety issue: No ]
- The cumulative dose of morphine administered and the number of days of treatment, [ Time Frame: 28 days ] [ Designated as safety issue: No ]
- the incidence and duration of febrile neutropenia [ Time Frame: 28 jours ] [ Designated as safety issue: No ]
- - The incidence and duration of treatment of anti-infective and antifungal [ Time Frame: 28 jours ] [ Designated as safety issue: No ]
- The incidence and duration of total parenteral nutrition, [ Time Frame: 28 jours ] [ Designated as safety issue: No ]
- - The duration of Release aplasia (ANC> 500/mm3), [ Time Frame: 28 days ] [ Designated as safety issue: No ]
- The duration of the hospitalization [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 28 days ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 90 |
| Study Start Date: | April 2011 |
| Estimated Study Completion Date: | November 2013 |
| Estimated Primary Completion Date: | October 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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 ®. |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01426295
Contacts
| Contact: Thomas Gastinne, MD | thomas.gastinne@chu-nantes.fr |
Locations
| France | |
| Nantes Universty Hospital | Recruiting |
| Nantes, France, 44200 | |
| Contact: Thomas Gastinne, M D | |
| Contact: Mohammad Mohty | |
Sponsors and Collaborators
Nantes University Hospital
EUSA Pharma (US), Inc.
Investigators
| Principal Investigator: | Thomas Gastinne, M D | Nantes University Hospital |
More Information
No publications provided
| Responsible Party: | Nantes University Hospital |
| ClinicalTrials.gov Identifier: | NCT01426295 History of Changes |
| Other Study ID Numbers: | BRD 10/06-C |
| Study First Received: | August 26, 2011 |
| Last Updated: | August 30, 2011 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by Nantes University Hospital:
|
hematologic disease candidates for autologous or allogeneic bone marrow |
Additional relevant MeSH terms:
|
Hematologic Diseases |
ClinicalTrials.gov processed this record on May 23, 2013