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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
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| 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. | 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. |
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Inclusion Criteria:
Exclusion Criteria: Patients were excluded if
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| Name | Affiliation | Role |
|---|---|---|
| Abdulrazzaq Y. Al khazzan, MClinPharm | University of Science and Technology | Principal Investigator |
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All individual participant data that underlie results in a publication.
At the date that related to the time when summary data are published.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 15, 2017 | Nov 15, 2017 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 15, 2017 | Nov 15, 2017 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D013280 | Stomatitis |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D006170 | Gum Arabic |
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D053149 | Plant Gums |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
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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.
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|
| Chemotherapy | Drug | Patients of control group and study group (Gum Arabic group) received chemotherapy according to type and stage of cancer. |
|
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| Lifestyle counseling | Behavioral | Lifestyle counseling pertaining to the optimal nutrition and daily routine for oral hygiene. |
|
| D011134 |
| Polysaccharides |
| D002241 | Carbohydrates |
| D053147 | Plant Exudates |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D013812 | Therapeutics |