Head and Neck Squamous Cell Carcinoma, Xerostomia
Conditions
Keywords
Xerostomia, Dexamethasone, Radiation therapy, Salivary gland, Head and neck cancer, Corticosteroid injection
Brief summary
This study evaluates the feasibility and safety of ultrasound-guided intraglandular dexamethasone (corticosteroid) injections into the salivary glands of patients undergoing radiation therapy for head and neck cancer. Primarily, to determine among patients undergoing radiation therapy (RT) as primary with or without chemotherapy for head and neck cancer, the feasibility of intraglandular corticosteroid injections to the salivary glands as measured by missed or delayed days of radiation therapy due to the planned intervention. Secondarily, to determine safety of intraglandular injections to the salivary glands as measured by the incidence of adverse events. Exploratory endpoints will also be tracked to determine, if among the same population, intraglandular corticosteroid injections are efficacious in minimizing the deleterious effects of radiation treatment to the salivary glands as measured by salivary flow rates and patient reported outcomes.
Detailed description
This project will be divided into multiple phases - for this first phase, investigators plan to assess the safety and feasibility of the planned intervention. Using the introductory and background principles established above, investigators have planned the following intervention based off of available published data: serial intraglandular dexamethasone injections to salivary gland(s) affected by planned radiation treatment for non-salivary head and neck cancer. Ultrasound-guided technique will then be used to inject 1 cc of 4mg/mL of dexamethasone into each involved gland (up to 4 total glands) for the first five patients enrolled. The last five patients enrolled will have 1cc of 10mg/mL of dexamethasone injected into each involved gland (up to 4 total glands). Injections are administered at two time points: within 3 days of initiation of radiation therapy and within 1-3 days of starting the 3rd week of radiation therapy. The ultimate aim of this study is to provide enrolled patients prolonged avoidance of radiation-induced salivary damage by minimizing the inflammatory-mediated destruction of salivary gland tissue, as well as decreasing the incidence of post-treatment xerostomia and its deleterious effect on oral and dental hygiene, nutrition, voice, and overall quality of life.
Interventions
DRUGDexamethasone 4mg/mL
The 4 mg/mL injection strength may be used for intralesional and soft tissue administration. Doses range from 0.2 mg to 4 mg injected as a single dose at the appropriate site. 1 cc injected per gland via ultrasound-guided intraparenchymal technique into each involved salivary gland (up to 4 glands), via 2-3 injection sites that have been established to produce clinically sufficient distribution of injected solution.
DRUGDexamethasone 10mg/mL
1 cc of 10mg/mL dexamethasone sodium phosphate injection solution injected per gland via ultrasound-guided intraparenchymal technique into each involved salivary gland (up to 4 glands), via 2-3 injection sites per gland.
Sponsors
University of California, Davis
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Dose-escalation design: The first 5 patients enrolled receive 1 cc of 4mg/mL dexamethasone per gland. Following safety review by the DSMB, the last 5 patients enrolled receive 1 cc of 10mg/mL dexamethasone per gland. Each gland (up to 4) receives injections at two time points during radiation therapy.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients between the ages of 18-80 with recent primary diagnosis of Oropharyngeal, Nasopharyngeal, Hypopharyngeal or Laryngeal Squamous Cell Carcinoma * Radiation therapy as primary with or without chemotherapy * Mean dose greater than 20 Gy to 2 or more salivary glands based on dose volume histogram analysis in the radiation treatment planning software
Exclusion criteria
* Patients less than 18 years of age * Patients greater than 80 years of age * Patients undergoing any surgical therapies for head and neck cancer * Tumor involvement of salivary gland * History of salivary gland removal * History of prior head and neck radiation therapy * History of the following xerostomia-inducing autoimmune diseases: Sjogren's, Lupus, IGG4, and Rheumatoid Arthritis * History of lymphoma * History of chronic steroid use (greater than 3 months) within the past year * History of recent steroid use (in the 7 days prior to enrollment in the study) * History of radioactive iodine * History of adverse reactions to steroids * History of recurrent sialadenitis, sialoliths, or sialocele * History of Mumps * Chronic adrenal insufficiency * Malignant tumor or enlarged lymph nodes interfering with pathway for ultrasound-guided injections * Vulnerable populations: prisoners, adult patients unable to consent, pregnant women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Missed or Delayed Days of Radiation Therapy Due to Steroid Injection | From first steroid injection through completion of radiation therapy, up to 6 weeks | Primary endpoint: Missed or delayed days of RT due to steroid injection. Count of radiation therapy treatment days that were missed or delayed as a direct result of the intraparenchymal dexamethasone injection procedure. To be assessed at every patient encounter. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Experiencing Adverse Events | From first steroid injection up to 12 weeks (3 months post-treatment) | Safety and feasibility at 3 months following investigational treatment. To be assessed at every patient encounter. Incidence of adverse events including, but not limited to: injection-site pain reported longer than 24 hours post-procedure, seroma, hematoma, missed injections, sialadenitis. |
| Patient Tolerance of Injection Procedure | At each injection visit: Day 0 (pre-chemo/radiation) and Week 3 of radiation therapy | Assessment of patient tolerance during and after each ultrasound-guided intraparenchymal dexamethasone injection procedure. |
| Ability to Inject 1cc of Dexamethasone Into Multiple Salivary Glands | At each injection visit: Day 0 (pre-chemo/radiation) and Week 3 of radiation therapy | Feasibility assessment of the ability to successfully inject 1cc of dexamethasone solution into multiple salivary glands (up to 4) as planned per protocol. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORLane Squires, MD
University of California, Davis
Outcome results
None listed