Oral Hygiene Regimen in Patients on HCT
Primary Purpose
Oral Mucositis
Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
.02% Chlorohexidine Gluconate
3% Sodium Bicarbonate
Nystatin 10000U/ml
Extra Soft Toothbrush
Supersaturated Calcium Phosphate
Sponsored by
About this trial
This is an interventional prevention trial for Oral Mucositis
Eligibility Criteria
Inclusion Criteria:
- 3 to 16 years patients
- Male and female
- Allogeneic transplant
Patient receiving conditioning regime
- CYTOXAN, ATG, FLUDARABINE
- BUSULPHAN/CYTOXAN/ATG WITH MTX
- BUSULPHAN/CYTOXAN WITH MTX
- FLUDARABINE/BUSULPHAN
Exclusion Criteria:
- Patient age greater than 16 years and less than 3 years.
- Previous radiotherapy
- Had more than one graft.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Control
Group 1
Group 2
Arm Description
0.02% Chlorohexidine Gluconate: Mouth Rinse, 5ml, qid 3% Sodium Bicarbonate, Mouth Rinse, 5ml, qid Nystatin 10000U/ml : Mouth rinse, 5ml, qid
0.02% Chlorohexidine Gluconate: Mouth Rinse, 5ml, qid 3% Sodium Bicarbonate, Mouth Rinse, 5ml, qid Nystatin 10000U/ml : Mouth rinse, 5ml, qid Extra soft toothbrush, brushing with saline bd
0.02% Chlorohexidine Gluconate: Mouth Rinse, 5ml, qid 3% Sodium Bicarbonate, Mouth Rinse, 5ml, qid Nystatin 10000U/ml : Mouth rinse, 5ml, qid Supersaturated Calcium Phosphate Spray, 5ml qid
Outcomes
Primary Outcome Measures
Oral Mucositis Incidence
Presence of Oral Mucositis
Secondary Outcome Measures
Oral Mucositis Severity
Severity of Oral Mucositis measured using WHO criteria
Full Information
NCT ID
NCT02662374
First Posted
January 19, 2016
Last Updated
January 21, 2016
Sponsor
Riyadh Colleges of Dentistry and Pharmacy
Collaborators
King Faisal Specialist Hospital & Research Center
1. Study Identification
Unique Protocol Identification Number
NCT02662374
Brief Title
Oral Hygiene Regimen in Patients on HCT
Official Title
Efficacy of Two Different Oral Hygiene Regimens on the Incidence and Severity of Oral Mucositis in Patients Receiving Hematopoietic Stem Cell Transplantation - A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Unknown status
Study Start Date
September 2015 (undefined)
Primary Completion Date
April 2016 (Anticipated)
Study Completion Date
May 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Riyadh Colleges of Dentistry and Pharmacy
Collaborators
King Faisal Specialist Hospital & Research Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Oral mucositis is one of the most common debilitating forms of mucositis that arise from high dose chemotherapy and radiotherapy. It is reported that almost 75% patients undergoing hematopoietic cell transplantation (HCT) develop oral mucositis at different levels of severity. The objective of this prospective study was to assess the efficacy of the addition of supersaturated calcium phosphate oral spray and the addition of an extra soft tooth brush to the basic OH in addition to the currently existing oral hygiene protocol regimen (0.2% Chlorhexidine Gluconate + 3% Sodium Bicarbonate+ Nystatin 100000 U/ml) in reducing the severity of oral mucositis among patients receiving chemotherapy for HCT.
60 patients receiving chemotherapy for HCT were randomly allocated to four groups of 15 patients each The oral mucositis was recorded according to WHO criteria and the progression of the oral mucositis was monitored from the day of admission (day
1) to the day of discharge (day 28). The absolute neutrophil count, platelet counts and salivary flow rate of all patients was recorded.
Detailed Description
This study will be prospective randomized case controlled study
Oral mucositis and oral hygiene protocol intervention:
45 patients admitted at King Faisal specialist hospital and Research Center in Riyadh for HCT and receiving chemotherapy regimen will be observed for the incidence and severity of oral mucositis.
Inclusion criteria:
3 to 16 years patients
Male and female
Allogeneic transplant
Patient receiving conditioning regime
CYTOXAN, ATG, FLUDARABINE
BUSULPHAN/CYTOXAN/ATG WITH MTX
BUSULPHAN/CYTOXAN WITH MTX
FLUDARABINE/BUSULPHAN
Exclusion criteria:
Patient age greater than 16 years and less than 3 years.
Previous radiotherapy
Had more than one graft.
Data Collection The child's age, gender, living area, type of disease, conditioning treatment protocol, absolute neutrophil count level, platelet count, use of opiate analgesics and patient reported outcome (pain, ability to eat, saliva flow rate and it is thickness) will be recorded.
Each patient will be examined once daily until discharge using the WHO criteria (see appendix I) At day -1
All patient will receive an oral examination before chemo regimen or HCT started using the WHO oral health assessment form and the OM form as baseline for each patient.
Start of the oral health protocol
Day 0, day 5, day10, day20, and day 25 Examination by tongue depressor and penlight to fill the OM form only and application of the oral hygiene protocol.
Oral health care protocol (OHCP):
Patients who fit the inclusion criteria will be randomly assigned to one of the following three groups Control group (15 patient) The control group will receive oral hygiene using the following protocol
Chlorhexidine gluconate as a mouth wash 4 times daily
Sodium bicarbonate mouth wash 4 times daily
Patient can rinse by sterile water any time
Nystatin will be administered 4 times.
Test group1 (15 patient)
Twice a day oral prophylaxis by extra soft brush and water
Chlorhexidine gluconate as a mouth wash 4 times daily
Sodium bicarbonate mouth wash 4 times daily
Patient can rinse by sterile water any time
Nystatin will be administered 4 times.
Test group 2(15 patient)
Supersaturated Calcium Spray 4 times daily
Chlorhexidine gluconate as a mouth wash 4 times daily
Sodium bicarbonate mouth wash 4 times daily
Patient can rinse by sterile water any time
Nystatin will be administered 4 times.
Test group 3(15 patient)
Twice a day oral prophylaxis by extra soft brush and water Supersaturated Calcium Spray 4 times daily.
Chlorhexidine gluconate as a mouth wash 4 times daily
Sodium bicarbonate mouth wash 4 times daily
Patient can rinse by sterile water any time
Nystatin will be administered 4 times.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Mucositis
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
45 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Active Comparator
Arm Description
0.02% Chlorohexidine Gluconate: Mouth Rinse, 5ml, qid 3% Sodium Bicarbonate, Mouth Rinse, 5ml, qid Nystatin 10000U/ml : Mouth rinse, 5ml, qid
Arm Title
Group 1
Arm Type
Experimental
Arm Description
0.02% Chlorohexidine Gluconate: Mouth Rinse, 5ml, qid 3% Sodium Bicarbonate, Mouth Rinse, 5ml, qid Nystatin 10000U/ml : Mouth rinse, 5ml, qid Extra soft toothbrush, brushing with saline bd
Arm Title
Group 2
Arm Type
Experimental
Arm Description
0.02% Chlorohexidine Gluconate: Mouth Rinse, 5ml, qid 3% Sodium Bicarbonate, Mouth Rinse, 5ml, qid Nystatin 10000U/ml : Mouth rinse, 5ml, qid Supersaturated Calcium Phosphate Spray, 5ml qid
Intervention Type
Drug
Intervention Name(s)
.02% Chlorohexidine Gluconate
Other Intervention Name(s)
Clorasept (ArRiyadh Pharmaceuticals, Riyadh, Saudi Arabia)
Intervention Description
5ml of the drug in mouthwash form to be swished four times a day
Intervention Type
Drug
Intervention Name(s)
3% Sodium Bicarbonate
Other Intervention Name(s)
3% Na2CO3
Intervention Description
5ml of the drug in the form of a prepared solution to be swished four times a day
Intervention Type
Drug
Intervention Name(s)
Nystatin 10000U/ml
Other Intervention Name(s)
Mycostatin (Amman Pharmacuetical Corp. Amman, Jordan
Intervention Description
5ml of the drug in mouthwash form to be swished and swallowed four times a day
Intervention Type
Device
Intervention Name(s)
Extra Soft Toothbrush
Intervention Description
To be moistened with 0.9% normal Saline and used twice daily to remove dental plaque
Intervention Type
Drug
Intervention Name(s)
Supersaturated Calcium Phosphate
Other Intervention Name(s)
Moistir (Kingswood laboratories Inc., Indianapolis IN USA)
Intervention Description
5ml of the solution to be swished four times a day
Primary Outcome Measure Information:
Title
Oral Mucositis Incidence
Description
Presence of Oral Mucositis
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Oral Mucositis Severity
Description
Severity of Oral Mucositis measured using WHO criteria
Time Frame
28 Days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
3 to 16 years patients
Male and female
Allogeneic transplant
Patient receiving conditioning regime
CYTOXAN, ATG, FLUDARABINE
BUSULPHAN/CYTOXAN/ATG WITH MTX
BUSULPHAN/CYTOXAN WITH MTX
FLUDARABINE/BUSULPHAN
Exclusion Criteria:
Patient age greater than 16 years and less than 3 years.
Previous radiotherapy
Had more than one graft.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
abdullah R alshammery, PhD
Organizational Affiliation
RiyadhCPD
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Oral Hygiene Regimen in Patients on HCT
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