Prevention of chemotherapy-induced stomatitis

The comparison of Effectiveness of mouthwash Benzydamine and combination of Benzydamine-Sucralfate in patients with malignancy undergoing chemotherapy

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT2012101311099N1

Enrollment

Registered

2013-05-18

Start date

2012-09-11

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chemotherapy-induced mucositis. Other and unspecified lesions of oral mucosa

Interventions

Intervention 1: Control group: Mouthwash Benzydamine hydrochloride .15%, produced by Behvazan company-three times a day- after meal 15 ml- rinse and spit out. Intervention 2: Intervention group: Com

Prevention

Control group: Mouthwash Benzydamine hydrochloride .15%, produced by Behvazan company-three times a day- after meal 15 ml- rinse and spit out

Intervention group: Combination of Benzydamine-Sucralfate (mouthwash Benzydamine hydrochloride .15%15ml + powdered tab sucralfate 500 mg)-three times a day after meal -rinse and spit out sucralfat

Eligibility

Sex/Gender

All

Age

14 Years to 90 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Possess one of hematologic malignancies( acute lymphoid leukemia (ALL) or acute myeloid leukemia (AML) according to the oncologist- similar chemotherapy treatment planning- patients are beginning to chemotherapy (new case)- absence of any fungal,viral or other lesions in the patient's mouth Exclusion criteria: appearance of fungal or viral lesions in the patient's mouth- lack of patient cooperation protocol X or Y

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Pain. Timepoint: Day 0(Concurrent with intervention)-days 6,9,12 and 14 after the start of intervention. Method of measurement: VAS scale.;Erythema. Timepoint: Day 0(Concurrent with intervention)-days 6,9,12 and 14 after the start of intervention. Method of measurement: Square centimeter.;Grading of stomatitis. Timepoint: Day 0(Concurrent with intervention)-days 6,9,12 and 14 after the start of intervention. Method of measurement: WHO grading.;Ulcer. Timepoint: Day 0(Concurrent with intervention)-days 6,9,12and 14 after the start of intervention. Method of measurement: Square centimeter.	—

Measure

Time frame

Pain. Timepoint: Day 0(Concurrent with intervention)-days 6,9,12 and 14 after the start of intervention. Method of measurement: VAS scale.;Erythema. Timepoint: Day 0(Concurrent with intervention)-days 6,9,12 and 14 after the start of intervention. Method of measurement: Square centimeter.;Grading of stomatitis. Timepoint: Day 0(Concurrent with intervention)-days 6,9,12 and 14 after the start of intervention. Method of measurement: WHO grading.;Ulcer. Timepoint: Day 0(Concurrent with intervention)-days 6,9,12and 14 after the start of intervention. Method of measurement: Square centimeter.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr.Mahrooz Ershadi

Department of Oral Medicine Faculty of Dentistry Shahid Sadoghi University of Medical Sciences-Yazd

drershadi@yahoo.com+98 937 326 4731

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026