- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01758562
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®
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
ZH
-
Zurich, ZH, Switzerland, 8091
- University Hospital Zurich, Centre of Clinical Nursing Science
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
NO_INTERVENTION: State-of-the-art mouth care
|
|
ACTIVE_COMPARATOR: Mouth rinse Caphosol
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Duration of oral mucositis
Time Frame: 20-30 days
|
20-30 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Rebecca Spirig, Prof MD, University Hospital Zurich, Centre of Clinical Nursing Science
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Capo
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Allogeneic Stem Cell Transplantation
-
University Hospital, GenevaRecruitingAllogeneic Hematopoietic Stem Cell Transplantation | Hematopoietic Stem Cell Transplantation | Autologous Hematopoietic Stem Cell TransplantationSwitzerland
-
Medical University of GrazCompletedAllogeneic Stem Cell Transplantation
-
Mitchell Horwitz, MDPfizerTerminatedAllogeneic Stem Cell TransplantationUnited States
-
Pierrel Research Europe GmbHRoche Pharma AGTerminatedAllogeneic Stem Cell TransplantationAustria, Germany, Spain
-
H. Kim LyerlyNational Cancer Institute (NCI); National Institutes of Health (NIH)TerminatedAllogeneic Stem Cell TransplantationUnited States
-
IRCCS Azienda Ospedaliero-Universitaria di BolognaCompletedGVHD | Allogeneic Stem Cell TransplantationItaly
-
Sidney Kimmel Cancer Center at Thomas Jefferson...National Cancer Institute (NCI)TerminatedALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATIONUnited States
-
Universitaire Ziekenhuizen KU LeuvenUnknownHematopoietic Stem Cell Transplantation | Hematopoietic Stem Cell Transplantation, Allogeneic
-
Central Hospital, Nancy, FranceRecruitingAllogeneic Hematopoietic Stem Cell TransplantationFrance
-
Medical College of WisconsinNational Cancer Institute (NCI); National Heart, Lung, and Blood Institute... and other collaboratorsCompletedAllogeneic Hematopoietic Stem Cell TransplantationUnited States
Clinical Trials on Caphosol
-
Amphia HospitalErasmus Medical CenterTerminatedSmall Cell Lung Cancer | Non Small Cell Lung CancerNetherlands
-
New York Head & Neck InstituteCompleted
-
Nantes University HospitalJazz PharmaceuticalsCompletedHematologic DiseaseFrance
-
Tampere University HospitalTurku University Hospital; Kuopio University HospitalCompleted
-
Impaqtt FoundationMemorial Sloan Kettering Cancer Center; Novartis; Pfizer; Leiden University Medical... and other collaboratorsCompletedRenal Cell Carcinoma | Hepatocellular Carcinoma | Gastrointestinal Stromal Tumors | Oral ComplaintsNetherlands
-
Jazz PharmaceuticalsUnknownOral MucositisUnited States
-
Medical College of WisconsinTerminatedOral MucositisUnited States
-
M.D. Anderson Cancer CenterCompleted
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedUnspecified Childhood Solid Tumor, Protocol Specific | Chronic Myelomonocytic Leukemia | Juvenile Myelomonocytic Leukemia | Secondary Acute Myeloid Leukemia | Childhood Acute Myeloid Leukemia in Remission | Mucositis | Childhood Acute Lymphoblastic Leukemia in Remission | Childhood Chronic Myelogenous... and other conditionsUnited States, Canada, Australia
-
The University of Texas Health Science Center at...South Texas Veterans Health Care SystemCompleted