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

University of Science and Technology, Yemen

Status and phase: Completed; Phase 2

Conditions: Chemotherapy-induced Oral Mucositis

Treatments: Drug: Gum Arabic; Drug: Chemotherapy; Behavioral: Lifestyle counseling

Study type: Interventional

Funder types: Other

Identifiers

NCT03348241

UST Yemen

Details and patient eligibility

About

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.

Enrollment: 386 patients

Sex: All

Ages: 14 to 83 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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386 participants in 2 patient groups

Gum Arabic group

Experimental group

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.

Treatment:

Drug: Chemotherapy

Drug: Gum Arabic

Behavioral: Lifestyle counseling

Control group

Other group

Description:

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

Treatment:

Drug: Chemotherapy

Behavioral: Lifestyle counseling