Condition category
Oral Health
Date applied
11/08/2015
Date assigned
07/10/2015
Last edited
07/10/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Chemotherapy is a type of cancer treatment which works by killing the cancer cells so that they can’t spread. Although it is an effective cancer treatment, it does have side effects. The drugs used in chemotherapy cannot distinguish between the fast-growing cancer cells and healthy types of fast-growing cells in the body. One of the most common cells affected are part of the mucous membrane, in a condition known as mucositis. The mucous membrane acts to line the parts of the body which come into contact with air, such as in the mouth and digestive system (gastrointestinal tract). Oral mucositis is the most common type of mucositis in cancer patients, and can lead to a number of problems, such as mouth ulcers, pain, increased risk of infection and nutritional problems due to difficulty swallowing. There are a number of ways to help treat patients suffering from oral mucositis. This study aims to compare how effective an oral aid gel (zytee) which is used to treat mouth ulcers, with taking granulocyte-colony stimulating factor (GCSF) which helps to increase the number of white blood cells that are released into the blood, helping to fight infection.

Who can participate?
Children with cancer, on chemotherapy treatment with oral mucositis.

What does the study involve?
Participants are randomly divided into one of two groups. The first group are treated with the oral aid (zytee gel), and the second group are treated with granulocyte-colony stimulating factor (GCSF), which is taken in oral form.

What are the possible benefits and risks of participating?
Possible benefits of participating are increasing knowledge about oral health, as well as patients receiving treatment free of charge. There are no risks of participating in the study,

Where is the study run from?
Hospital Universiti Sains Malaysia (Malaysia)

When is the study starting and how long is it expected to run for?
April 2013 to April 2016

Who is funding the study?
Hospital Universiti Sains Malaysia (Malaysia)

Who is the main contact?
Dr Malid Alshannuki

Trial website

Contact information

Type

Scientific

Primary contact

Dr Milad Alshannuki

ORCID ID

http://orcid.org/0000-0003-2926-7449

Contact details

Lot pt 1207 Bandar Baru
Kota Bharu
16150
Malaysia

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Randomized controlled trial of oral GCSF versus oral aid for treating oral mucositis in patients with childhood cancer receiving chemotherapy

Acronym

Study hypothesis

There are significance differences of the outcomes of treating oral mucositis between oral GCSF and oral aid groups .

Ethics approval

Ethics Committee at Universiti Sains Malaysia, ref: USMKK/PPP/JEPeM[261.3(16)]

Study design

Single-centre randomized parallel trial

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Oral mucositis

Intervention

Medication (routinely used in the pediatric Oncology ward in HUSM) will be given three times daily (morning, evening, and night) until the oral mucositis resolved.
Block randomization will be used for randomization.The basic idea of block randomization is to divide potential patients into m blocks of size2n, randomize each block such that n patients are allocated to A and n to B ,then choose the blocks randomly.This method ensures equal treatment allocation within each block if the complete block is used.Example: Two treatments of A, B and Block size of 2 x 2= 4

Group A: Oral aid (zytee) Composition: Choline salicylate and benzalkonium chloride.
Group B : Oral granulocyte colony stimulating factor GCSF (0 .1ml).

Possible treatment allocations within each block are:
1. AABB
2. BBAA
3. ABAB
4. BABA
5. ABBA
6. BAAB

Intervention type

Drug

Phase

Drug names

1. Oral aid (zytee) Composition: Choline salicylate and benzalkonium chloride
2. GCSF (granulocyte colony stimulating factor)

Primary outcome measures

Healing of the oral mucositis between oral GCSF and oral aid, measured at baseline, day 3 and day 7.

Secondary outcome measures

1. Relief the pain of oral mucositis also measured at baseline, measured at baseline, day 3 and day 7. Who oral toxicity scale will be used to assess the severity the oral toxicity are ranked on a scale of 1 to 4, with 1 being minor soreness and painless, 2 is painful erythema, edema, or ulcers but able to eat ,3 is painful erythema, edema, or ulcers but unable eat,and 4 If there is sever pain and requirement for parenteral or enteral support .
2. Improvement in absolute neutrophile count (ANC) measured pre (at baseline) and post (on day 7).

Overall trial start date

01/04/2013

Overall trial end date

01/04/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 3-12 years
2. Have oral mucositis
3. On chemotherapy treatment

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

76

Participant exclusion criteria

1. Other causes of oral ulcer such as trauma and CT disease
2. Cancer patient who is not under chemotherapy

Recruitment start date

01/04/2013

Recruitment end date

01/04/2016

Locations

Countries of recruitment

Malaysia

Trial participating centre

Hospital Universiti Sains Malaysia
15200 Kota Bharu Kelantan
Kota Bharu
16150
Malaysia

Sponsor information

Organisation

Hospital Universiti Sains Malaysia

Sponsor details

Pediatric Oncology School of Medical Sciences
University Sains Malaysia Health Campus
Kota Bharu
16150
Malaysia

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Hospital Universiti Sains Malaysia

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

We are planning to publish the whole study (randomized controlled trial of oral GCSF vs. oral aid in treating oral mucositis in childhood cancer patients receiving chemotherapy), but if the results are significant we may separate them into 3 papers (in terms of time of heal, relief of oral pain, and improvement of ANC).

Intention to publish date

01/10/2016

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes