Using Gum Arabic for Cancer Patients to Protect From Oral Mucositis Caused by Chemotherapy: ِِِAn Experimental Study

Study Overview
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Brief Summary
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This study was designed to investigate the effect of Gum Arabic (GA) on cancer patients to prevent chemotherapy-induced oral mucositis. Cancer patients who will receive chemotherapy were divided into two groups; study Gum Arabic group (which received GA with chemotherapy) and control group (chemotherapy alone); and the participants were recruited to reach 190 patients in the study group and 184 patients in control group. This clinical trial was conducted in outpatient chemotherapy sections at Radiation and Isotopes Center of Khartoum. This study was designed to test the theory that say the chemotherapy-induced oral mucositis will significantly decrease after ingestion 30 grams as daily dose of Gum Arabic in a form of solution for six weeks during therapy.

Official Title
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Randomized Controlled Trial on the Effect of Gum Arabic to Reduce Incidence of Oral Mucositis Induced by Chemotherapy for Cancer Patients

Conditions
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Chemotherapy-induced Oral Mucositis

Intervention / Treatment
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* Drug: Gum Arabic
* Drug: Chemotherapy
* Behavioral: Lifestyle counseling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients whom well diagnosed with cancer in any stage were eligible for enrolment if chemotherapy is part of their treatment plan. Exclusion Criteria: Patients were excluded if they had received recent previous chemotherapy or radiotherapy, they had oral mucositis or periodontitis, there is evidence of any systemic diseases.

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 83 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is an experimental study. It was a two-arm randomized, controlled, open-label trial. The patients was categorized into two groups; study group and control group. Patients of study group was received a dose of 30 grams Gum Arabic per day as oral solution (dissolved in 250 ml purified water) for six weeks along with the chemotherapy prescribed, while patients of control group was received only chemotherapy regimen.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gum Arabic group<br>Patients of study group was received a dose of 30 grams Gum Arabic per day as oral solution (dissolved in 250 ml purified water) for six weeks along with the chemotherapy prescribed addition to verbal instructions pertaining to the optimal nutrition and daily routine for oral hygiene. | Drug: Gum Arabic<br>* Gum acacia, also known as Gum Arabic is exuded from acacia trees; mainly from Acacia Senegal (gum Hashab or Kordofan gum) which was used in this study.<br>* Other names: Acacia Senegal;Drug: Chemotherapy<br>* Patients of control group and study group (Gum Arabic group) received chemotherapy according to type and stage of cancer.<br>* Other names: Chemotherapy agents;Behavioral: Lifestyle counseling<br>* Lifestyle counseling pertaining to the optimal nutrition and daily routine for oral hygiene.<br>|
| Other: Control group<br>Patients of control group was received only chemotherapy regimen and verbal counseling pertaining to the optimal nutrition and daily routine for oral hygiene. | Drug: Chemotherapy<br>* Patients of control group and study group (Gum Arabic group) received chemotherapy according to type and stage of cancer.<br>* Other names: Chemotherapy agents;Behavioral: Lifestyle counseling<br>* Lifestyle counseling pertaining to the optimal nutrition and daily routine for oral hygiene.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effect of Gum Arabic to prevent Chemotherapy-induced Oral Mucositis was the primary outcome that assessed using World Health Organization Mucositis Scoring. | The primary outcome measure of oral mucositis in cancer patients who received chemotherapy was depend on presence or absence oral mucositis after commencement the treatment because they were new diagnosed cases and free from oral mucositis. World Health Organization Mucositis Scale, was the scoring system used to assess oral mucositis based on a combination of subjective (soreness as described by the patient), objective (presence of erythema and ulcerations) and functional (ability to eat solids, liquids or nothing by mouth) outcomes. During six weeks of follow up there were specific questions that asked by researcher and had been answered by patient regarding oral mucositis. Those questions summarized as follow: 1. Does the oral mucositis was occurred during this week? 2. If Yes. Is there was soreness, erythema or 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gum Arabic, Cancer patients, Chemotherapy, Oral mucositis