N/A
Completed N=25
Low-Level Laser Therapy for Prevention of Oral Mucositis
Source: ClinicalTrials.gov NCT02723604 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Feb 2023
Primary outcomePrimary: Number of Participants With Severe (Common Terminology Criteria for Adverse Events Version 4.0 [CTCAE v. 4.0] Grade 3-5 Oral Mucositis in Patients Treated to a Cumulative Radiation Dose of at Least 5000 cGy — 15 Participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Severe (Common Terminology Criteria for Adverse Events Version 4.0 [CTCAE v. 4.0] Grade 3-5 Oral Mucositis in Patients Treated to a Cumulative Radiation Dose of at Least 5000 cGy |
15 | — |
| PRIMARY Number of Participants With Severe World Health Organization [WHO] (Grade 3-4) Oral Mucositis in Patients Treated to a Cumulative Radiation Dose of at Least 5000 cGy |
10 | — |
| SECONDARY Change in OM-related QOL Assessed Using FACT Questionnaire |
2.3 | — |
| SECONDARY Duration of Oral Mucositis |
4 | — |
| SECONDARY Number of Participants With Any Grade Oral Mucositis in Patients Treated to a Cumulative Radiation Dose of at Least 5000 cGy |
23 | — |
| SECONDARY Number of Participants With Dysgeusia Assessed by CTCAE v. 4.0 |
0; 23; 0; 0; 0 | — |
| SECONDARY Number of Participants With Dysphagia Assessed by CTCAE v. 4.0 and Diet Assessment |
2; 17; 4; 0; 0 | — |
| SECONDARY Number of Participants With Pain as Assessed by the Visual Analogue Scale (VAS) |
0; 0; 2; 0; 5; 2 | — |
| SECONDARY Number of Participants With Radiodermatitis Assessed by CTCAE v. 4.0 |
5; 16; 2; 0; 0 | — |
| SECONDARY Number of Participants With Trismus Assessed by Measurement of Interincisal Distance |
2 | — |
| SECONDARY Number of Participants With Xerostomia Assessed by CTCAE v. 4.0 |
2; 17; 4; 0; 0 | — |
| SECONDARY Mean Cumulative Radiation Dose at Time of Onset of Severe (CTCAE v. 4.0 Grade 3-4) Oral Mucositis |
53.5 | — |
| SECONDARY Time to Onset of Severe (CTCAE v. 4.0 Grade 3-4) Oral Mucositis Following the Initiation of Radiotherapy |
NA | — |
Eligibility Criteria
Inclusion Criteria
- Willing and able to understand and sign informed consent form approved by the institutional review board (IRB)
- Males or females greater than or equal to 18 years old
- Biopsy-proven head and neck cancer (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 centigray (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 patients of child-bearing potential must have a negative pregnancy test prior to enrollment
Exclusion Criteria
- Patient 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
- Patient planned to receive altered fractionation radiotherapy or multiple fractions per day
- Patient is using a pre-existing feeding tube for nutritional support at the time of study entry
- Women who are pregnant or breast-feeding
- Patient 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
Data sourced from ClinicalTrials.gov (NCT02723604). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.