Clinical trial · Interventional
Low-Level Laser Therapy for Prevention of Oral Mucositis
A Phase II Prospective Trial of Low-Level Laser Therapy for Prevention of Oral Mucositis in Patients Receiving Chemotherapy and Radiation for Head and Neck Cancer
NCT02682992CI-TRIAL-00057776completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The overall purpose of this study is to examine the efficacy of prophylactic low-level laser therapy (LLLT) to reduce the incidence of oral mucositis and adverse events in patients receiving combined modality therapy consisting of chemotherapy and radiation therapy for head and neck cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Mucositis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Low Level Laser Therapy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Low Level Laser Therapy
- description
- Patients meeting the eligibility criteria will be enrolled to receive prophylactic LLLT in addition to standard of care measures for oral mucositis or other toxicity of therapy. The radiation and chemotherapy dose, schedule, modality, technique, and any required adjustments will not be influenced by this protocol and will follow standard existing institutional practices.
- interventionNames
- Device: Low Level Laser Therapy
Primary outcomes (2)
- measure
- Percentage of Participants With Severe (WHO Grade 3-4) Oral Mucositis
- timeFrame
- Up to 1 year
- description
- Percentage of participants with severe oral mucositis per the World Health Organization (WHO grade 3-4) (ulcerative lesions of the oral mucosa) in patients treated to a cumulative radiation dose of at least 5000 cGy.
- measure
- Percentage of Participants With Severe (CTCAE v. 4.0 Grade 3-5) Oral Mucositis
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Willing and able to understand and sign informed consent form approved by the HRPO. * Males or females greater than or equal to 18 years old. * Biopsy-proven HNC including cancers of the nasopharynx, oropharynx, larynx, hypopharynx, or HNC of unknown primary origin amenable to therapy with radiation and concurrent chemotherapy. * Patients who are planned to receive definitive or adjuvant radiotherapy with concurrent platinum-based chemotherapy. * Patients whose clinical treatment plans include a continuous course of external beam radiotherapy by intensity-modulated radiation therapy (IMRT) and/or image-guided radiation therapy (IGRT), given as a cumulative dose of 5000 - 7000 cGy in single daily fractions of 180 - 200 cGy, combined with a concurrent course of weekly or tri-weekly cisplatin or carboplatin chemotherapy. * Karnofsky performance status score \>60. * Female subjects of child-bearing potential must have a negative pregnancy test prior to enrollment. Exclusion Criteria: * Subject has evidence of current mucositis, mucosal ulceration, or unhealed surgical wounds from surgical resection or biopsy. * Prior radiation to the head and neck. * Patients with gross tumor involvement of the oral cavity or oral mucosa. * Subjects planned to receive altered fractionation radiotherapy or multiple fractions per day * Subject is using a pre-existing feeding tube for nutritional support at the time of study entry. * Women who are pregnant or breast-feeding. * Subject plans to receive concurrent chemotherapy, other than the regimens specified in the inclusion criteria. * Patients who have chronic immunosuppression or are on current immunosuppressive therapies. * Patients who have a contraindication to radiation therapy. * Patients enrolled on another investigational trial for oral mucositis prevention. * Life expectancy of less than 3 months. * Unable or unwilling to adhere to study-specified procedures
References
Publications (0)
Data not yet available
No reference posted for this study.