Mouthwash therapies for pediatric chemotherapy mucositis

Double-Blind Clinical Trial Evaluating the Effectiveness of Amphotericin B Mouthwash versus an Antacid–Nystatin–Diphenhydramine Mouthwash for Chemotherapy-Induced Mucositis in Pediatric Patients

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20210715051904N3

Enrollment

Registered

2025-08-30

Start date

2025-09-22

Completion date

Unknown

Last updated

2025-09-15

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

Conditions

Pediatric cancer, Chemotherapy, mucositis. Oral mucositis (ulcerative) due to antineoplastic therapy

Interventions

Intervention 1: Control Group: Participants in Group A will receive a compounded mouthwash containing 5 mL of diphenhydramine hydrochloride syrup (Darou Pakhsh Pharmaceutical Co., Tehran, Iran), 5 mL

Eligibility

Sex/Gender

All

Age

6 Years to 18 Years

Inclusion criteria

Inclusion criteria: Age between 6 and 18 years Diagnosis of chemotherapy-induced oral mucositis (Grade 2 or 3) based on WHO criteria. No other local etiologies for mucositis (e.g., trauma, vitamin deficiencies) Signed informed consent by legal guardians and patient assent

Exclusion criteria

Exclusion criteria: Inability to cooperate with the treatment regimen Known hypersensitivity or allergy to Amphotericin B, antacids, nystatin, or diphenhydramine.

Design outcomes

Primary

Measure	Time frame
Time to complete resolution of oral mucositis. Timepoint: Mucositis severity will be assessed every 3 days from baseline until complete healing (Grade 0 mucositis) or up to 21 days post-intervention initiation. Method of measurement: Clinical examination by a blinded pediatric dental specialist using the WHO Oral Mucositis Grading Scale: Grade 0: No mucositis. Grade 1: Soreness and/or erythema. Grade 2: Erythema and ulcers, patient able to swallow solid foods. Grade 3: Ulcers, patient limited to a liquid diet. Grade 4: Severe ulceration, alimentation impossible, requiring enteral or parenteral support. Lesion size will be measured using calibrated millimeter paper (±1 mm accuracy).	—

Measure

Time frame

Time to complete resolution of oral mucositis. Timepoint: Mucositis severity will be assessed every 3 days from baseline until complete healing (Grade 0 mucositis) or up to 21 days post-intervention initiation. Method of measurement: Clinical examination by a blinded pediatric dental specialist using the WHO Oral Mucositis Grading Scale: Grade 0: No mucositis. Grade 1: Soreness and/or erythema. Grade 2: Erythema and ulcers, patient able to swallow solid foods. Grade 3: Ulcers, patient limited to a liquid diet. Grade 4: Severe ulceration, alimentation impossible, requiring enteral or parenteral support. Lesion size will be measured using calibrated millimeter paper (±1 mm accuracy).

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Secondary

Measure	Time frame
Incidence of adverse events related to mouthwash use. Timepoint: Monitored continuously throughout the 21-day intervention. Method of measurement: Patient/caregiver-reported symptoms recorded at each clinical visit and spontaneous reporting.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactNader Shakibazad

Boushehr University of Medical Sciences

nshakibazad@gmail.com+98 77 3335 1048

Outcome results

None listed

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