The use of a laser and pilocarpine in improving saliva secretion in patients with head and neck cancer who have undergone radiochemotherapy

The synergistic effect of low-level laser and pilocarpine hydrochloride on saliva in patients with head and neck cancer who receive radiochemotherapy: Clinical randomized controlled study

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN56133161

Enrollment

Registered

2023-08-21

Start date

2022-06-22

Completion date

Unknown

Last updated

2023-09-04

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

Conditions

Patients with head and neck cancer and radiochemotherapy Cancer

Interventions

Study Design and Purpose: This study employs a randomized controlled trial design to evaluate the effectiveness of different interventions in maintaining oral health during radiochemotherapy. The goal

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. The minimum radiation dose to which the patient is exposed is 50 Gy 2. Radiation should be at least above the parotid gland and the submandibular gland on both sides 3. The patients are 18 years old or over 4. The patients did not undergo radiotherapy before 5. The patients did not undergo chemotherapy for at least the past two months 6. Karnofsky performance scale above 60

Exclusion criteria

Exclusion criteria: 1. Sjogren's syndrome, diabetes and autoimmune diseases 2. Clinically significant uncontrolled cardiac, renal, pulmonary, visual problems or other chronic diseases that could potentially interfere with the evaluation of the safety and efficacy of pilocarpine 3. Tricyclic antidepressants, antihistamines with anticholinergic effects or Beta-blockers 4. Pilocarpine for ophthalmic indications was also excluded from the study 5. Tumor located in the parotid gland, submandibular gland, the blood or the floor of the mouth

Design outcomes

Primary

Measure	Time frame
Volume of saliva secretion measured by weighing collected saliva samples on an accurate scale and subtracting the weight of the used tube from the obtained result in periods R1/R2/R3. (R: radiotherapy phase) R1: when a patient receives their first radiochemotherapy session R2: when a patient receives their last radiochemotherapy session R3: after 3 months of ending the radiochemotherapy sessions	—

Secondary

Measure	Time frame
Saliva pH measured using standard laboratory kits designed for this function in the periods R1/R2/R3. (R: radiotherapy phase) R1: when a patient receives their first radiochemotherapy session R2: when a patient receives their last radiochemotherapy session R3: after 3 months of ending the radiochemotherapy sessions	—

Countries

Syria

Outcome results

None listed

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