Evaluation of the efficiency of photobiomodulation in the prevention of oral mucositis? in chemotherapy-treated cancer patients

Clinical and laboratory evaluation of the efficiency of preconditioning with photobiomodulation in preventing chemotherapy-induced oral mucositis

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN70634383

Enrollment

Registered

2023-07-24

Start date

2023-07-21

Completion date

Unknown

Last updated

2025-02-17

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

Conditions

Prevention of oral mucositis? in chemotherapy-treated cancer patients Oral Health

Interventions

After achieving acceptance criteria, randomization will be performed using the online software www.graphpad.com/quickcalcs/randomize1.cfm. • Group 1: Cancer patients who will receive basic oral care i

and 980 nm extraoral before undergoing chemotherapy.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Cancer patients undergoing chemotherapy for the first time with the same risk of mucositis: 1. Solid tumor patients 1.1. Chemotherapy (5-Fluorouracil) intravenously or orally 1.2. Neutrophil count = 1500 cells/µL 1.3. Platelet count = 100,000/µl 1.4. A healthy oral mucosa 1.5. Karnofsky performance status index >60

Exclusion criteria

Exclusion criteria: 1. Radiotherapy in the head and neck area 2. Malignant or potentially malignant lesions of the oral cavity 3. Oral infections 4. Oral bleeding 5. Undergoing any other measures to prevent oral mucositis 6. Patients unable to commit to the study

Design outcomes

Primary

Measure	Time frame
Presence and severity of oral mucositis measured using the WHO scale and Oral Mucositis Assessment Scale OMAS at 7 and 14 days after the start of the first chemotherapy session	—

Secondary

Measure	Time frame
Secondary outcome measures are assessed at baseline, 7 and 14 days: 1. Oral Assessment measured using the Oral Assessment Guide (Eilers, Berger, and Petersen 1988) 2. Quality of life measured using the Oral Health Impact Profile (OHIP-14) and (PROMS) Patient-Reported Oral Mucositis Symptoms scale 3. xerostomia assessment using the LENT SOMA scale 4. Assay of saliva interleukin-6 (IL-6) by enzyme-linked immunosorbent assay (ELISA) 5. Measurement of nitrites in saliva using the spectroscopic method 6. Oral pain using a visual analogue scale (VAS)	—

Measure

Time frame

Secondary outcome measures are assessed at baseline, 7 and 14 days: 1. Oral Assessment measured using the Oral Assessment Guide (Eilers, Berger, and Petersen 1988) 2. Quality of life measured using the Oral Health Impact Profile (OHIP-14) and (PROMS) Patient-Reported Oral Mucositis Symptoms scale 3. xerostomia assessment using the LENT SOMA scale 4. Assay of saliva interleukin-6 (IL-6) by enzyme-linked immunosorbent assay (ELISA) 5. Measurement of nitrites in saliva using the spectroscopic method 6. Oral pain using a visual analogue scale (VAS)

—

Countries

Syria

Outcome results

None listed

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