Chemotherapy-induced Oral MucositisPhase 2NCT03348241
Using Gum Arabic for Cancer Patients to Protect From Oral Mucositis Caused by Chemotherapy: ِِِAn Experimental Study
A Phase 2 study testing Gum Arabic, Chemotherapy and Lifestyle counseling in people with Chemotherapy-induced Oral Mucositis, run by University of Science and Technology, Yemen.
Trial 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… Read more about this study
- Who is it for?
- Ages 14 to 83 years
- Conditions the study is for
- Chemotherapy-induced Oral Mucositis
- What is being tested?
- Gum Arabic, Chemotherapy and Lifestyle counseling
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 386 participants
- Where
- No sites listed yet
- Study dates
- 26 Oct 2015to Aug 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 83 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients whom well diagnosed with cancer in any stage were eligible for enrolment if chemotherapy is part of their treatment plan.
Who cannot join
- they had received recent previous chemotherapy or radiotherapy,
- they had oral mucositis or periodontitis,
- there is evidence of any systemic diseases.
About this study
Official title: Randomized Controlled Trial on the Effect of Gum Arabic to Reduce Incidence of Oral Mucositis Induced by Chemotherapy for Cancer Patients
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
- Being tested
- Gum Arabic, Chemotherapy, Lifestyle counseling
- Keywords
- Gum Arabic, Cancer patients, Chemotherapy, Oral mucositis
- Medical subject headings
- Stomatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gum ArabicDrug
Also called Acacia Senegal
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.
ChemotherapyDrug
Also called Chemotherapy agents
Patients of control group and study group (Gum Arabic group) received chemotherapy according to type and stage of cancer.
Lifestyle counselingBehavioural
Lifestyle counseling pertaining to the optimal nutrition and daily routine for oral hygiene.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Chemotherapy; Behavioral: Lifestyle counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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?
Measured: Six weeks for each participant from starting therapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2017
- Study start26 Oct 2015
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-induced Oral MucositisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 386 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Science and Technology, Yemen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdulrazzaq Yahya Ahmed Al Khazzan, University of Science and Technology, Yemen
- Investigators
- Abdulrazzaq Y. Al khazzan, MClinPharm, Principal investigator, University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03348241
- Sponsor's protocol ID
- UST Yemen
- Status last verified
- Nov 2017
- First submitted
- 1 Nov 2017
- Last updated
- 20 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All individual participant data that underlie results in a publication.
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial on the Effect of Gum Arabic to Reduce Incidence of Oral Mucositis Induced by Chemotherapy for Cancer Patients
- ClinicalTrials.gov ID
- NCT03348241
- Acronym / sponsor ID
- UST Yemen
- Conditions
- Chemotherapy-induced Oral Mucositis
- Keywords
- Gum Arabic, Cancer patients, Chemotherapy, Oral mucositis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 386 participants (actual)
- Lead sponsor
- University of Science and Technology, YemenUniversity, hospital or other
- Study start
- 26 Oct 2015 (actual)
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 20 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Gum Arabic group | Experimental | Drug: Gum Arabic, Drug: Chemotherapy, Behavioral: Lifestyle counselingPatients 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. |
| Control group | Other | Drug: Chemotherapy, Behavioral: Lifestyle counselingPatients of control group was received only chemotherapy regimen and verbal counseling pertaining to the optimal nutrition and daily routine for oral hygiene. |
Who may qualify
- Ages
- 14 to 83 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients whom well diagnosed with cancer in any stage were eligible for enrolment if chemotherapy is part of their treatment plan.
Key exclusion criteria (3 listed)
- they had received recent previous chemotherapy or radiotherapy,
- they had oral mucositis or periodontitis,
- there is evidence of any systemic diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gum ArabicAlso: Acacia SenegalGum 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. | Drug | Gum Arabic group |
| ChemotherapyAlso: Chemotherapy agentsPatients of control group and study group (Gum Arabic group) received chemotherapy according to type and stage of cancer. | Drug | Control group, Gum Arabic group |
| Lifestyle counselingLifestyle counseling pertaining to the optimal nutrition and daily routine for oral hygiene. | Behavioural | Control group, Gum Arabic group |
Primary outcome
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?
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2017.
- Individual participant dataSharing planned: Yes. All individual participant data that underlie results in a publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abdulrazzaq Y. Al khazzan, MClinPharm principal investigator
University of Science and Technology
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gum Arabic, Chemotherapy and Lifestyle counseling in people with Chemotherapy-induced Oral Mucositis, run by University of Science and Technology, Yemen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2017.