Randomized Controlled Trial on the Effect of Gum Arabic to Reduce Incidence of Oral Mucositis Induced by Chemotherapy for Cancer Patients
Phase: PHASE2
Conditions: Chemotherapy-induced Oral Mucositis
Sponsor: University of Science and Technology, Yemen

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Using Gum Arabic for Cancer Patients to Protect From 
Oral Mucositis Caused by Chemotherapy: An 
Experimental Study
 
 
 
NCT ID not yet assigned
 
 
 
 
15/11/2017 
 
 
 
 
 
 
 
 
 
 

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Study protocol 
Background  
Investigate agents which can be used to prevent or treat chemotherapy-induced 
oral mucositis is a primary concern for clinicians and researchers. The synthesis 
pharmacological drugs are costly and associated with much side effects resulting in 
patient non-compliance. So, there is a need to find alternative therapies especially 
from natural sources as these are cost effective and have no or minimal side effects. In 
this regard, Gum Arabic is very convenient since this polymer is readily available on 
nature and does not require any further complex method of purification. Also it is a 
safe material for biological applications. 
Objective of study 
The purpose of this research was to investigate the effect of Gum Arabic to prevent 
chemotherapy-induced oral mucositis in cancer patients.  
Inclusion criteria 
Patients whom well diagnosed with cancer in any stage were eligible for 
enrolment if chemotherapy is a part of the treatment plan. 
Exclusion criteria 
Patients will be excluded if recently received chemotherapy or radiotherapy, 
presence of oral mucositis or periodontitis, or there is evidence of any systemic 
diseases. 
 Dose, preparation and administration of gum arabic 
The daily dose of Gum Arabic will be divided in 30 grams sachet, the content 
of sachet will dissolve once in 100 ml purified water to form solution, and consuming 

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in six divided doses. Patient will provide by measuring cap to using 20-ml every two 
hours as mouthwash for a minute then swallow.  
The total number of sachets are 42 for a period of six weeks; each patient will 
give 21 sachet of Gum Arabic at the first day of chemotherapy treatment to be used 
during the next three weeks of the treatment period, then  the remain quantity (21 
sachets) will provide for the next three weeks. 
Modification on the preparation and administration 
Because frequent use during the day (six times; each 2 hours) and high 
viscosity of gum arabic solution, which lead to withdrawn some patients after were 
enrolled in this study.  Researcher was tried to solve this problem at two sides; firstly, 
by increasing the quantity of purified water as solvent for Gum Arabic to 250 
milliliters instead of 100 milliliters to reduce viscosity of solution. On the other hand, 
patient was informed to use this quantity of solution twice daily; half at 9 morning 
and the remaining half at 9 evening to decrease frequent uses. 
Oral mucositis assessment: 
 Based on a combination of subjective, objective and functional outcomes, using 
World Health Organization Oral Toxicity Scale (WHO Score): subjective – soreness 
as described by the patient, objective – presence of erythema and ulcerations, and 
functional – ability to eat solids, liquids or nothing by mouth 
Assessment gum Arabic effect 
For each participant data of oral mucositis will be start after getting ethical 
committee permission & permission from Radiation and Isotopes Center of Khartoum 
(RICK) authority. Informed consent also will be taken from study participants.  

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Data will gather via data collection sheet which composed of two sections;  
that will fill through six weeks of patient follow up. The first part for assessment 
patient regarding oral mucositis after chemotherapy by weekly telephone call for 
patient based on ready-scheduled appointments. The second part contain a basic 
information and characteristics of patient, which will record by researcher during the 
first day at first cycle of chemotherapy. In addition, there is meeting with patients by 
researcher in chemotherapy rooms when the participant return to the next cycle of 
chemotherapy either weekly, bi-weekly or every three weeks, according to treatment 
regimen. 
When the researcher is contacted with the patient either by telephone call or 
when meeting participant in the hospital during the next chemotherapy cycle; there 
will be specific questions directed by the researcher to be answered by the patient 
regarding oral mucositis. Those questions will be summarized as follow: 1. Does the 
oral mucositis was occurred during this week? 2. If Yes. Is there was soreness, 
erythema, ulcers in mouth of participant? 3. The day that oral mucositis was started 
and eliminated? 4. If the patient belong to study group; Is Gum Arabic still used 
regularly? Six weeks for each participant from starting therapy. 
Cessation of trial therapy 
No stop for recruiting the participants to study group until the planned number 
was completed, but there was a period of three weeks the new recruitment was 
suspended to separate study group from control group in try to reduce the bias (reduce 
the confounding) between the two groups and give a chance to follow up the study 
group patients. By August 2016 we stopped participants recruitment and follow up; 
since the sample size proposed and follow up planned was completed. 

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Statistical analysis 
The collected data were arranged, coded, tabulated, and introduced to a 
personal computer using Statistical Package for Social Science (IBM SPSS Statistics 
20.lnk). P. values equal or less than 0.05 was considered significant. The data of 332 
patients who completed this study were documented and reviewed to give a 
qualitative analysis of the frequencies. The descriptions were based on the data that 
documented from personal file of patient in designed sheet prepared by the researcher. 
Data were presented and suitable analysis was done according to the type of data 
obtained for each parameter. All numeric variables were expressed at 95% confidence 
intervals. Student  t-test was used to assess the statistical significance of the difference 
between  means of the two groups.