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

NCT ID: NCT03348241

Last Updated: 2017-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

386 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-26

Study Completion Date

2016-08-31

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.

Detailed Description

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Conditions

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Chemotherapy-induced Oral Mucositis

Keywords

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Gum Arabic Cancer patients Chemotherapy Oral mucositis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Gum Arabic 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 addition to verbal instructions pertaining to the optimal nutrition and daily routine for oral hygiene.

Group Type EXPERIMENTAL

Gum Arabic

Intervention Type 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.

Chemotherapy

Intervention Type DRUG

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

Lifestyle counseling

Intervention Type BEHAVIORAL

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

Control group

Patients of control group was received only chemotherapy regimen and verbal counseling pertaining to the optimal nutrition and daily routine for oral hygiene.

Group Type OTHER

Chemotherapy

Intervention Type DRUG

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

Lifestyle counseling

Intervention Type BEHAVIORAL

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

Interventions

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Gum Arabic

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.

Intervention Type DRUG

Chemotherapy

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

Intervention Type DRUG

Lifestyle counseling

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

Intervention Type BEHAVIORAL

Other Intervention Names

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Acacia Senegal Chemotherapy agents

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

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

14 Years

Maximum Eligible Age

83 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Science and Technology, Yemen

OTHER

Sponsor Role lead

Responsible Party

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Abdulrazzaq Yahya Ahmed Al Khazzan

Academic staff member, Faculty of Pharmacy, University of Science and Technology, Sana'a, Yemen.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Abdulrazzaq Y. Al khazzan, MClinPharm

Role: PRINCIPAL_INVESTIGATOR

University of Science and Technology

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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UST Yemen

Identifier Type: -

Identifier Source: org_study_id