Caphosol® Versus State-of-the-art Mouthcare in Patients With Allogeneic Stem Cell Transplantation: a Randomized Controlled Study About the Efficacy of the Mouth Rinse Caphosol®

University of Zurich (UZH)

Status: Completed

Conditions: Allogeneic Stem Cell Transplantation

Treatments: Device: Caphosol

Study type: Interventional

Funder types: Other

Identifiers

NCT01758562

Capo

Details and patient eligibility

About

Randomized controlled study about the efficacy of the mouth rinse Caphosol in patients with allogeneic stem cell transplantation. 85% of the patients receive a severe oral mucositis due to their treatment.

70 patients will be randomized in the intervention (Caphosol) or in the standard (state-of-the-art) group. Primary endpoint is the duration of the mucositis, secondary endpoints are the occurence of oral mucositis measured with the WHO-scale and the occurence of pain measured with the NRS-scale (Numeric Rating Scale).

• Trial with medical device

Enrollment: 72 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Allogeneic stem cell transplantation
• Male and female patients age 18-80
• Signed informed consent after information

Exclusion criteria

• Contra-indications due to ethical reasons
• Unable to read or write
• Unable to speak or understand the german language
• Low-salt diet

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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72 participants in 2 patient groups

State-of-the-art mouth care

No Intervention group

Mouth rinse Caphosol

Active Comparator group

Description:

Mouth rinse,aqueous solution. Caphosol is a preparation comprising two separately packaged aqueous solutions, a phosphate solution and a calcium solution, which, when both solutions are combined in equal volumes, forms a solution supersaturated with respect to both calcium and phosphate ions.

Treatment:

Device: Caphosol