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

NCT03348241 | Completed Phase 2

• 1 other identifier: UST Yemen
• Study Type: interventional
• Target: 386
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Chemotherapy-induced Oral Mucositis

Keywords

Gum Arabic; Cancer patients; Chemotherapy; Oral mucositis

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

Gum Arabic group

EXPERIMENTAL

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; Drug: Chemotherapy; Behavioral: Lifestyle counseling

Control group

OTHER

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; Behavioral: Lifestyle counseling

Interventions

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.

Also known as: Acacia Senegal

Gum Arabic group

Chemotherapy DRUG

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

Also known as: Chemotherapy agents

Control group; Gum Arabic group

Lifestyle counseling BEHAVIORAL

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

Control group; Gum Arabic group

Eligibility Criteria

• Age: 14 Years - 83 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients whom well diagnosed with cancer in any stage were eligible for enrolment if chemotherapy is part of their treatment plan.

You may not qualify if:

• they had received recent previous chemotherapy or radiotherapy,
• they had oral mucositis or periodontitis,
• there is evidence of any systemic diseases.

Sponsors & Collaborators

• University of Science and Technology, Yemen: lead

MeSH Terms

Conditions

Stomatitis

Interventions

Gum Arabic; Drug Therapy

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Plant Gums; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Plant Exudates; Biological Products; Complex Mixtures; Therapeutics

Study Officials

• Abdulrazzaq Y. Al khazzan, MClinPharm

  University of Science and Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Academic staff member, Faculty of Pharmacy, University of Science and Technology, Sana'a, Yemen.

Model Details: 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.

Study Record Dates

• First Submitted: November 1, 2017
• First Posted: November 20, 2017
• Study Start: October 26, 2015
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: November 20, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: At the date that related to the time when summary data are published.