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Oral MucositisPhase 4NCT02662374

Oral Hygiene Regimen in Patients on HCT

A Phase 4 study testing .02% Chlorohexidine Gluconate, 3% Sodium Bicarbonate and Nystatin 10000U/ml in people with Oral Mucositis, run by Riyadh Colleges of Dentistry and Pharmacy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 3 to 16 years
Conditions the study is for
Oral Mucositis
What is being tested?
.02% Chlorohexidine Gluconate, 3% Sodium Bicarbonate and Nystatin 10000U/ml
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
No sites listed yet
Study dates
Sep 2015to May 2016
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 16 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • Patient age greater than 16 years and less than 3 years.
  • Previous radiotherapy
  • Had more than one graft.

About this study

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

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.
Read the 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.
Conditions
Oral Mucositis
Being tested
.02% Chlorohexidine Gluconate, 3% Sodium Bicarbonate, Nystatin 10000U/ml, Extra Soft Toothbrush, Supersaturated Calcium Phosphate
Medical subject headings
Stomatitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • .02% Chlorohexidine GluconateDrug

    Also called Clorasept (ArRiyadh Pharmaceuticals, Riyadh, Saudi Arabia)

    5ml of the drug in mouthwash form to be swished four times a day

  • 3% Sodium BicarbonateDrug

    Also called 3% Na2CO3

    5ml of the drug in the form of a prepared solution to be swished four times a day

  • Nystatin 10000U/mlDrug

    Also called Mycostatin (Amman Pharmacuetical Corp. Amman, Jordan

    5ml of the drug in mouthwash form to be swished and swallowed four times a day

  • Extra Soft ToothbrushDevice

    To be moistened with 0.9% normal Saline and used twice daily to remove dental plaque

  • Supersaturated Calcium PhosphateDrug

    Also called Moistir (Kingswood laboratories Inc., Indianapolis IN USA)

    5ml of the solution to be swished four times a day

Study groups in NCT02662374
Study groupRoleWhat they receive
ControlActive comparator0.02% Chlorohexidine Gluconate: Mouth Rinse, 5ml, qid 3% Sodium Bicarbonate, Mouth Rinse, 5ml, qid Nystatin 10000U/ml : Mouth rinse, 5ml, qid
Receives: Drug: .02% Chlorohexidine Gluconate; Drug: 3% Sodium Bicarbonate; Drug: Nystatin 10000U/ml
Group 1Experimental0.02% 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
Receives: Drug: .02% Chlorohexidine Gluconate; Drug: 3% Sodium Bicarbonate; Drug: Nystatin 10000U/ml; Device: Extra Soft Toothbrush
Group 2Experimental0.02% 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
Receives: Drug: .02% Chlorohexidine Gluconate; Drug: 3% Sodium Bicarbonate; Drug: Nystatin 10000U/ml; Drug: Supersaturated Calcium Phosphate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Oral Mucositis Incidence

    Presence of Oral Mucositis

    Measured: 28 days

Secondary outcomes (1)

  1. Oral Mucositis Severity

    Severity of Oral Mucositis measured using WHO criteria

    Measured: 28 Days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jan 2016 (estimated)
  2. Study startSep 2015
  3. Primary completionApr 2016 (estimated)
  4. Study completionMay 2016 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
45 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02662374
Sponsor's protocol ID
RiyadhCDP
Status last verified
Jan 2016
First submitted
19 Jan 2016
Last updated
25 Jan 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing .02% Chlorohexidine Gluconate, 3% Sodium Bicarbonate and Nystatin 10000U/ml in people with Oral Mucositis, run by Riyadh Colleges of Dentistry and Pharmacy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 25 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Oral Mucositis Incidence (time frame: 28 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02662374.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2016.

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