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Efficacy of Low Level Laser Therapy for management of oral ulcers in carcinoma oral cavity patient receiving radiation.

Efficacy of photobiomodulation (Low-Level Laser Therapy) for management of radiation induced mucositis in carcinoma oral cavity patients: An open label prospective randomized controlled trial - NIL

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/03/063583
Enrollment
80
Registered
2024-03-04
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-01

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

Conditions

Health Condition 1: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx

Interventions

Intervention1: Low level laser therapy: Low-level laser will be applied to patients who develop grade II mucositis, in a scanning motion, 5 times a week, using a handheld diode laser ( NLase by IndiLa
hence the total energy delivered per point will be 1J. Laser will be given till the completion of radiotherapy. The changes in the grade of mucositis will be noted during the weekly clinical assessmen

Sponsors

AIIMS Raipur
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients with histologically proven squamous cell carcinoma of oral cavity undergoing radiotherapy in radical or adjuvant setting. RTOG grade 2 oral mucositis Performance status (KPS score) = 70 Adequate mouth opening (Inter incisor distance = 3 cm

Exclusion criteria

Exclusion criteria: Patients who had already received Neoadjuvant chemotherapy Patient being treated with palliative intent Patients with distant metastasis Patients with history of radiotherapy to same site

Design outcomes

Primary

MeasureTime frame
Patients being treated with laser therapy will have less progression to grade 3 and grade 4 oral mucositis during the treatment durationTimepoint: Baseline, 1st week, 2nd week, 3rd week, 4th week, 5th week, 6th week, 7th week of treatment. 1 month, 2 month, 3 month after completion of treatment

Secondary

MeasureTime frame
The number of interruptions will be less in the study group with laser therapy than in the control group.Timepoint: Baseline, 1st week, 2nd week, 3rd week, 4th week, 5th week, 6th week, 7th week of treatment

Countries

India

Contacts

Public ContactDr Swaroopa Madhuri Rath

All India Institue of medical Sciences, Raipur

sidnanda@yahoo.com9713711888

Outcome results

None listed

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