Investigating the effectiveness of Doxepin mouthwash in children over 7 years old undergoing chemotherapy

A Triple-Blinded, Randomized, Placebo-Controlled Trial to Examine the Safety and Efficacy of Doxepin Rinse in Managing Oral Mucositis in Children Older than 7 Years of Age Receiving Chemotherapy

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20230928059539N1

Enrollment

Registered

2024-01-24

Start date

2023-11-01

Completion date

Unknown

Last updated

2024-03-06

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

Conditions

Oral mucositis in children due to chemotherapy. Oral mucositis (ulcerative) due to antineoplastic therapy

Interventions

Intervention group: All patients are treated with the protocol approved by the department for the treatment of mucositis, and the patients who are in the placebo group are not morally harmed. Doxepin

Eligibility

Sex/Gender

All

Age

7 Years to No maximum

Inclusion criteria

Inclusion criteria: Having grade 3 or higher mucosit based on the mucosit criteria of the World Health Organization is a proven malignancy in the patient Age over 7 years

Exclusion criteria

Exclusion criteria: History of acute psychosis History of allergy to Doxepin History of receiving Doxepin by any means within 48 hours before the start of the study

Design outcomes

Primary

Measure	Time frame
Determining the amount of reduction or non-reduction of pain after using doxepin mouthwash. Timepoint: Evaluation of patients' pain at time points 1 hour before the start of mouthwash use, 1 hour after use, and then every 8 hours for 3 days. Method of measurement: The degree of pain is scored based on a numeric scale likert and in a range from 1 to 10, where 0 means complete painlessness, and 10 means the worst pain.;The side effects after using doxepin mouthwash. Timepoint: In all days up to one week after taking doxepin, side effects and oral tolerance are checked. Method of measurement: Side effects will be checked by asking the patient or his/her caregivers.	—

Measure

Time frame

Determining the amount of reduction or non-reduction of pain after using doxepin mouthwash. Timepoint: Evaluation of patients' pain at time points 1 hour before the start of mouthwash use, 1 hour after use, and then every 8 hours for 3 days. Method of measurement: The degree of pain is scored based on a numeric scale likert and in a range from 1 to 10, where 0 means complete painlessness, and 10 means the worst pain.;The side effects after using doxepin mouthwash. Timepoint: In all days up to one week after taking doxepin, side effects and oral tolerance are checked. Method of measurement: Side effects will be checked by asking the patient or his/her caregivers.

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Secondary

Measure	Time frame
The amount of reduction in the use of systemic painkillers after the use of doxepin mouthwash. Timepoint: The amount of reduction in the use of systemic painkillers in the first, second and third days after the use of doxepin mouthwash. Method of measurement: The patient or his/her caregivers will be asked about the frequency of taking systemic painkillers during the first, second and third days after the intervention.	—

Measure

Time frame

The amount of reduction in the use of systemic painkillers after the use of doxepin mouthwash. Timepoint: The amount of reduction in the use of systemic painkillers in the first, second and third days after the use of doxepin mouthwash. Method of measurement: The patient or his/her caregivers will be asked about the frequency of taking systemic painkillers during the first, second and third days after the intervention.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactVahid Jam Barandozi

Shahid Beheshti University of Medical Sciences

v.j.barandozi@gmail.com+98 21 7708 3127

Outcome results

None listed

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