Oral Hygiene Regimen in Patients on HCT

Oral Mucositis Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02662374
• Other study ID #: RiyadhCDP
• Status: Enrolling by invitation
• Phase: Phase 4
• First received: January 19, 2016
• Last updated: January 21, 2016
• Start date: September 2015
• Est. completion date: May 2016

Study information

• Verified date: January 2016
• Source: Riyadh Colleges of Dentistry and Pharmacy
• Contact: n/a
• Is FDA regulated: No
• Health authority: Saudi Arabia: Ministry for Higher Education
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 45
• Est. completion date: May 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 16 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Mucositis
• Oral Mucositis
• Stomatitis

Intervention

Drug:
• .02% Chlorohexidine Gluconate
5ml of the drug in mouthwash form to be swished four times a day
• 3% Sodium Bicarbonate
5ml of the drug in the form of a prepared solution to be swished four times a day
• Nystatin 10000U/ml
5ml of the drug in mouthwash form to be swished and swallowed four times a day

Device:
• Extra Soft Toothbrush
To be moistened with 0.9% normal Saline and used twice daily to remove dental plaque

Drug:
• Supersaturated Calcium Phosphate
5ml of the solution to be swished four times a day

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Riyadh Colleges of Dentistry and Pharmacy	King Faisal Specialist Hospital & Research Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oral Mucositis Incidence	Presence of Oral Mucositis	28 days	No
Secondary	Oral Mucositis Severity	Severity of Oral Mucositis measured using WHO criteria	28 Days	No