- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03348241
Using Gum Arabic for Cancer Patients to Protect From Oral Mucositis Caused by Chemotherapy: ِِِAn Experimental Study
Randomized Controlled Trial on the Effect of Gum Arabic to Reduce Incidence of Oral Mucositis Induced by Chemotherapy for Cancer Patients
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
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:
Patients of control group and study group (Gum Arabic group) received chemotherapy according to type and stage of cancer.
Other Names:
Lifestyle counseling pertaining to the optimal nutrition and daily routine for oral hygiene.
|
Other: 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.
|
Patients of control group and study group (Gum Arabic group) received chemotherapy according to type and stage of cancer.
Other Names:
Lifestyle counseling pertaining to the optimal nutrition and daily routine for oral hygiene.
|
What is the study measuring?
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.
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? |
Six weeks for each participant from starting therapy.
|
Collaborators and Investigators
Investigators
- Principal Investigator: Abdulrazzaq Y. Al khazzan, MClinPharm, University of Science and Technology
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UST Yemen
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Informed Consent Form (ICF)
- Clinical Study Report (CSR)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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