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®

NCT01758562 | Completed DMC

• 1 other identifier: Capo
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Allogeneic Stem Cell Transplantation

Outcome Measures

Primary Outcomes (1)

• Duration of oral mucositis

  20-30 days

Study Arms (2)

State-of-the-art mouth care

NO INTERVENTION

Mouth rinse Caphosol

ACTIVE COMPARATOR

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.

Device: Caphosol

Interventions

Caphosol DEVICE

Mouth rinse Caphosol

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University Hospital Zurich, Centre of Clinical Nursing Science

Zurich, Canton of Zurich, 8091, Switzerland

Location

Study Officials

• Rebecca Spirig, Prof MD

  University Hospital Zurich, Centre of Clinical Nursing Science

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 24, 2012
• First Posted: January 1, 2013
• Study Start: January 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: August 15, 2014

Record last verified: 2014-08

Locations

CH (1)