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Evaluation the effect of sucralfate 15% mouthwash for Prevention and treatment mouth sores induced by chemotherapy drugs

Evaluation of the efficacy of 15% sucralfate mouth wash in the prevention and treatment of 5-fluorouracil induced oral mucositis in cancer patients in sari city

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT201107053014N4
Enrollment
60
Registered
2012-04-27
Start date
2011-11-01
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

5-fluorouracil induced oral mucositis. Disease of oral cavity : stomatitis

Interventions

Intervention 1: Sucralfate , mouthwash , 15 percent , four times a day for a week. Intervention 2: Placebo mouthwash , 4 times a day for a week. Intervention 3: Sucralfate 15 percent mouth wash plus s
Prevention
Placebo
Treatment - Drugs
Sucralfate , mouthwash , 15 percent , four times a day for a week
Placebo mouthwash , 4 times a day for a week
Sucralfate 15 percent mouth wash plus syrup Hydroxyzine , four times a day until oral wound healing
Syrup Hydroxyzine plus placebo , four times a day until oral wound healing

Sponsors

Vice chancellor for research, Mazandaran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria:Cancer patients between 18-70 years receiving 5-fluorouracil containing chemotherapy regimens. Exclusion criteria: Sucralfate intolerance or inappropriate use of the mouth wash

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Mouth sores. Timepoint: every 3 days. Method of measurement: Use of the WHO table and ruler.

Secondary

MeasureTime frame
Pain. Timepoint: Before and after 1 months of intervention. Method of measurement: Visual analoug scale (VAS).;Dysphagia to liquids. Timepoint: Before and after 2 months of intervention. Method of measurement: Ask a question.;Dysphagia to solids. Timepoint: weekly. Method of measurement: Ask a question.;Bleeding. Timepoint: Before and after 2 months of intervention. Method of measurement: Ask a question.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactElham Azhdari

Vice chancellor for research, Mazandaran University of Medical Sciences

eli.azhdari@yahoo.com ? maammt@yahoo.com ? sasanpoorneda@gmail.com ? sh204ala@yahoo.com+98 15 1311 0267

Outcome results

None listed

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