Investigating the effect of probiotics on dry mouth after radiotherapy

Comparing the effect of probiotics with placebo on xerostomia in head and neck cancer patients undergoing radiation therapy

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20081202001483N5

Enrollment

Registered

2022-08-03

Start date

2022-09-01

Completion date

Unknown

Last updated

2025-07-21

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

Conditions

Xerostomia. Disturbances of salivary secretion

Interventions

Intervention 1: Intervention group: one probiotic lozenge (Lactogum) before going to bed for 60 days. Intervention 2: Control group: one placebo lozenge before going to bed for 60 days.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: All head and neck cancer patients who had radiotherapy (after 1-3 months) Functional level equal to or higher than 80 according to the Karnofski criterion Absence of any other oral disease Inability to understand the questionnaire

Exclusion criteria

Exclusion criteria: Parkinson disease Sjögren's disease Taking drugs that affect the function of saliva Pregnancy Diabetes Acquired immune deficiency syndrome History of antibiotic use in the last 30 days Use of antifungal drugs or antiseptic mouthwashes

Design outcomes

Primary

Measure	Time frame
Volume of unstimulated saliva. Timepoint: At the beginning of the study (before the start of the intervention), at the end of 2 months and at the end of 3 months. Method of measurement: Measuring the amount of saliva for 5 minutes in unstimulated conditions.;Volume of stimulated saliva. Timepoint: At the beginning of the study (before the start of the intervention), at the end of 2 months and at the end of 3 months. Method of measurement: Measuring the amount of saliva for 5 minutes in stimulating conditions (using an applicator dipped in fresh lemon juice).;Severity of xerostemia (Visual Analogue Scale; VAS). Timepoint: At the beginning of the study (before the start of the intervention), at the end of 2 months and at the end of 3 months. Method of measurement: The patient chooses a score from 0 (absence of dry mouth) to 10 (worst degree of dry mouth) according to the severity of dry mouth.	—

Measure

Time frame

Volume of unstimulated saliva. Timepoint: At the beginning of the study (before the start of the intervention), at the end of 2 months and at the end of 3 months. Method of measurement: Measuring the amount of saliva for 5 minutes in unstimulated conditions.;Volume of stimulated saliva. Timepoint: At the beginning of the study (before the start of the intervention), at the end of 2 months and at the end of 3 months. Method of measurement: Measuring the amount of saliva for 5 minutes in stimulating conditions (using an applicator dipped in fresh lemon juice).;Severity of xerostemia (Visual Analogue Scale; VAS). Timepoint: At the beginning of the study (before the start of the intervention), at the end of 2 months and at the end of 3 months. Method of measurement: The patient chooses a score from 0 (absence of dry mouth) to 10 (worst degree of dry mouth) according to the severity of dry mouth.

—

Secondary

Measure	Time frame
Score of EORTC QLQ HN43. Timepoint: At the beginning of the study (before the start of the intervention), at the end of 2 months and at the end of 3 months. Method of measurement: using persian version of EORTC QLQ HN43 questionnaire.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Maryam Akbari

Rasht University of Medical Sciences

maryamakbari_6699@yahoo.com+98 13 3323 8306

Outcome results

None listed

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