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

Primary Purpose

Chemotherapy-induced Oral Mucositis

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Gum Arabic
Chemotherapy
Lifestyle counseling
Sponsored by
University of Science and Technology, Yemen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chemotherapy-induced Oral Mucositis focused on measuring Gum Arabic, Cancer patients, Chemotherapy, Oral mucositis

Eligibility Criteria

14 Years - 83 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    Gum Arabic group

    Control group

    Arm Description

    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.

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

    Outcomes

    Primary Outcome Measures

    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?

    Secondary Outcome Measures

    Full Information

    First Posted
    November 1, 2017
    Last Updated
    November 17, 2017
    Sponsor
    University of Science and Technology, Yemen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03348241
    Brief Title
    Using Gum Arabic for Cancer Patients to Protect From Oral Mucositis Caused by Chemotherapy: ِِِAn Experimental Study
    Official Title
    Randomized Controlled Trial on the Effect of Gum Arabic to Reduce Incidence of Oral Mucositis Induced by Chemotherapy for Cancer Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    October 26, 2015 (Actual)
    Primary Completion Date
    August 2016 (Actual)
    Study Completion Date
    August 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Science and Technology, Yemen

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chemotherapy-induced Oral Mucositis
    Keywords
    Gum Arabic, Cancer patients, Chemotherapy, Oral mucositis

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    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)
    Allocation
    Randomized
    Enrollment
    386 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Gum Arabic group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Control group
    Arm Type
    Other
    Arm Description
    Patients of control group was received only chemotherapy regimen and verbal counseling pertaining to the optimal nutrition and daily routine for oral hygiene.
    Intervention Type
    Drug
    Intervention Name(s)
    Gum Arabic
    Other Intervention Name(s)
    Acacia Senegal
    Intervention Description
    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
    Intervention Name(s)
    Chemotherapy
    Other Intervention Name(s)
    Chemotherapy agents
    Intervention Description
    Patients of control group and study group (Gum Arabic group) received chemotherapy according to type and stage of cancer.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Lifestyle counseling
    Intervention Description
    Lifestyle counseling pertaining to the optimal nutrition and daily routine for oral hygiene.
    Primary Outcome Measure Information:
    Title
    The effect of Gum Arabic to prevent Chemotherapy-induced Oral Mucositis was the primary outcome that assessed using World Health Organization Mucositis Scoring.
    Description
    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?
    Time Frame
    Six weeks for each participant from starting therapy.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    14 Years
    Maximum Age & Unit of Time
    83 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Abdulrazzaq Y. Al khazzan, MClinPharm
    Organizational Affiliation
    University of Science and Technology
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    All individual participant data that underlie results in a publication.
    IPD Sharing Time Frame
    At the date that related to the time when summary data are published.

    Learn more about this trial

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

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