Transdermal Buprenorphine for the Treatment of Radiation-Induced Mucositis Pain in Head and Neck … (NCT04752384) | Clinical Trial Compass
CompletedPhase 2
Transdermal Buprenorphine for the Treatment of Radiation-Induced Mucositis Pain in Head and Neck Cancer Patients
United States20 participantsStarted 2021-07-08
Plain-language summary
This is a single-arm prospective clinical trial to determine the safety and feasibility of using transdermal buprenorphine in alleviation of radiation induced mucositis pain in head and neck cancer patients.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. Patients aged 18-80 years.
✓. Histologically confirmed malignancies involving the oral cavity, oropharynx, hypopharynx and larynx (including non-squamous cell histologies, salivary gland carcinomas and unknown primary tumors).
✓. Undergoing a course of either definitive radiation (dose of at least 50 Gy to the head and neck region) +/-chemotherapy or adjuvant radiation (at least 50 Gy to the head and neck region) +/- chemotherapy (Patients with a history of prior definitive course of radiation will be allowed).
✓. Eastern Cooperative Oncology Group (ECOG) Performance status ≤ 2
✓. Concurrent enrollment on interventional trial is allowed.
✓. English speaking and literate
✓. Patients will be allowed to take radiotherapy mix, viscous lidocaine or magic mouthwash like agents that do not contain opioids. Tylenol allowed for fever and mild pain before starting drug regimen.
✓. Adequate organ function: Minor dose adjustments for tramadol is required in severe liver and renal impairment so we would only include patients with adequate organ function outlined in below. No dose adjustment for renal or hepatic impairment is required for TD buprenorphine. Some other parameters like hemoglobin, platelets and white blood count (WBC) are required for administration of standard of care chemotherapy like cisplatin along with radiation in treatment of head and neck squamous cell carcinoma (HNSCC). They are not required for administration of buprenorphine or tramadol.
✕. Preexisting oral infection or ongoing toxicity from prior radiotherapy.
✕. History of substance abuse, positive urine drug screen in last six months.
✕. Patients with multiple distant metastasis (subjects with resectable oligometastasis will be allowed)
✕. Current or recent use (within four weeks of screening) of mixed opioid agonists/antagonists or other opioid antagonists. Methadone use within four weeks of screening.
✕. History of prolonged QTc\>greater than 450 milliseconds in males and greater than 470 milliseconds in females.
✕. Patients on systemic therapy (chemotherapy or immunotherapy) for another cancer subtype.
✕. Patients receiving induction chemotherapy prior to or after radiation/chemoradiation like patients with nasopharyngeal carcinoma