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

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.

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Key information

Conditions

Chemotherapy-induced Oral Mucositis Mouth Diseases Stomatitis Stomatognathic Diseases

Age range

14 year–83 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Gum Arabic

Drug

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.

Other names: Acacia Senegal

Chemotherapy

Drug

Patients of control group and study group (Gum Arabic group) received chemotherapy according to type and stage of cancer.

Other names: Chemotherapy agents

Lifestyle Counseling

Behavioral

Lifestyle counseling pertaining to the optimal nutrition and daily routine for oral hygiene.

Primary outcomes

The effect of Gum Arabic to prevent Chemotherapy-induced Oral Mucositis was the primary outcome that assessed using World Health Organization Mucositis Scoring.

Time frame: Six weeks for each participant from starting therapy.

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?

Sponsors and collaborators

Lead sponsor

University of Science and Technology, Yemen

Other

Registry information

Official study title

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

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2016
First posted: Nov 20, 2017
Registry last updated: Nov 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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