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Completed

NCT Number: NCT01426295

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

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).

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Key information

Conditions

Hematologic Disease Hematologic Diseases Hemic and Lymphatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Nantes Universty Hospital

Nantes, 44200, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Caphosol

Device

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.

Bicarbonate de sodium

Drug

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 ®.

Primary outcomes

  1. assess the cost-effectiveness ratio is the number of days with severe mucositis won.

    Time frame: up to 28 days

Secondary outcomes

  1. The number of days without medication morphine won

    Time frame: up to 28 days

  2. Aggregate saving medicines prescribed Supportive

    Time frame: up to 28 days

  3. The incidence of mucositis

    Time frame: up to 28 days

  4. The intensity of pain assessed with a visual analogue scale

    Time frame: up to 28 days

  5. The cumulative dose of morphine administered and the number of days of treatment,

    Time frame: 28 days

  6. The duration of febrile neutropenia

    Time frame: up to 28 days

  7. - The incidence and duration of treatment of anti-infective and antifungal

    Time frame: 28 jours

  8. The incidence of total parenteral nutrition

    Time frame: up to 28 days

  9. - The duration of Release aplasia (ANC> 500/mm3),

    Time frame: up to 28 days

  10. The duration of the hospitalization

    Time frame: participants will be followed for the duration of hospital stay, an expected average of 28 days

  11. The severity of mucositis

    Time frame: up to 28 days

  12. The duration of pain assessed with a visual analogue scale,

    Time frame: up to 28 days

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Collaborators

  • Jazz Pharmaceuticals

Registry information

Official study 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

Acronym: Caphosol

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
Aug 31, 2011
Registry last updated
May 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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