Clinical Trials Logo

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT02662374
Other study ID # RiyadhCDP
Secondary ID
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


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
See also
  Status Clinical Trial Phase
Completed NCT02229136 - Miracle Mouthwash Plus Hydrocortisone vs Prednisolone Mouth Rinse for Mouth Sores Caused by Everolimus Phase 2
Terminated NCT03843554 - Commensal Oral Microbiota in Head and Neck Cancer N/A
Completed NCT00938080 - Study to Assess Safety and Tolerability of AG013 in Oral Mucositis in Subjects Receiving Induction Chemotherapy for the Treatment of Cancers of the Head and Neck Phase 1
Completed NCT00756951 - Dose Ranging Study to Assess the Safety and Efficacy of SCV-07 for the Delay to Onset of Severe Oral Mucositis in Patients Receiving Chemoradiation Therapy for Head and Neck Cancer Phase 2
Completed NCT00701688 - Dose Escalation Study Of Palifermin in Pediatric Research Participants Undergoing Allogeneic Hematopoietic Stem Cell Transplantation Phase 1
Not yet recruiting NCT05059613 - Thalidomide With or Without Probiotics in Radioactive Oral Mucositis N/A
Completed NCT04440930 - White Tea for Prevention of Chemotherapy Induced Mucositis N/A
Completed NCT05705622 - The Effect of Nursing Education on Oral Mucositis in Bone Marrow Transplant Patients N/A
Completed NCT02399228 - A Trial of a Botanical Drug Containing East Indian Sandalwood Oil (EISO) for the Treatment of Oral Mucositis Phase 2
Withdrawn NCT02589860 - Analysis of Oral Mucositis in Patient's Undergoing Melphalan Conditioning and Autologous Stem Cell Transplant
Active, not recruiting NCT01772706 - Laser Mucite ORL : Effectiveness of Laser Therapy for Mucositis Induced by a Radio-chemotherapy in Head and Neck Cancer N/A
Enrolling by invitation NCT06122636 - Efficacy of a Probiotic and Microbiological Analysis on Oral Complications Induced by Antineoplastic Therapies in Patients With HNC N/A
Completed NCT03689712 - ROMAN: Phase 3 Trial Investigating the Effects of GC4419 on Radiation Induced Oral Mucositis in Head/Neck Cancer Patients Phase 3
Terminated NCT02539342 - Caphosol Study: Prevention of Oral Mucositis in Children, Adolescents and Young Adults Receiving Chemotherapy Phase 3
Completed NCT02555501 - Oral Mucositis and Laser Therapy Associated With Photodynamic Therapy Phase 3
Completed NCT01789658 - Cryotherapy for Prevention of Oral Mucositis in Children Undergoing Hematopoietic Stem Cell Transplantation N/A
Completed NCT00790322 - Efficacy and Safety Study of SBG vs Placebo in Head and Neck Cancer Patients Undergoing Radiation Therapy Phase 3
Recruiting NCT00549952 - Observational Study of Anti-Cancer Therapy Induced Oral Mucositis in Korean Cancer Patients N/A
Completed NCT00289003 - The Protective Effect of Soluble Beta-1,3/1,6-Glucan Compared to Placebo in Oral Mucositis in Head and Neck Cancer Patients Phase 2
Completed NCT05635929 - Oral Mucositis and Quality of Life With a Mucosa Topical Composition in Head & Neck Cancer Patients. N/A