Lidocaine Injection for Oropharyngeal Cancer
(856397 Trial)
Recruiting in Palo Alto (17 mi)
Overseen byRyan Carey, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: Ryan Carey
Disqualifiers: Radiation, Chemotherapy, Metastatic disease, others
No Placebo Group
Trial Summary
What is the purpose of this trial?Based on evidence that the local anesthetic lidocaine may have anticancer effects, this study will assess the safety and efficacy of intratumoral lidocaine injection at the time of direct laryngoscopy prior to TransOral Robotic Surgery (TORS) and neck dissection for oropharyngeal squamous cell carcinoma (OPSCC). The primary objective of the study is to determine if intratumoral lidocaine injection is safe and causes a major pathologic treatment effect in the primary tumor following surgical resection. The secondary objectives will be to determine if intratumoral lidocaine injection improves locoregional control rates, progression-free survival, metastasis-free survival, and overall survival compared to no injection.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the drug lidocaine injection for oropharyngeal cancer?
Lidocaine has been shown to have beneficial effects on cancer cell behavior and the immune response, which may influence cancer outcomes. Additionally, intravenous lidocaine has been found to decrease pain and reduce the need for opioids in head and neck cancer surgeries, suggesting potential benefits in managing cancer-related symptoms.
12345Is lidocaine injection safe for use in humans?
Lidocaine has been used safely in various forms, including intravenous and topical applications, for pain management in cancer patients, with a favorable side effect profile. However, there is variability in how it is absorbed in the body, and serious side effects like seizures can occur, so caution is advised when using it in standard doses.
23456How does the drug Lidocaine Injection differ from other treatments for oropharyngeal cancer?
Lidocaine Injection is unique because it involves directly injecting the drug into the tumor (intratumoral), which may help target the cancer cells more precisely compared to traditional methods like surgery or systemic chemotherapy that affect the whole body.
7891011Eligibility Criteria
This trial is for individuals with oropharyngeal squamous cell carcinoma (OPSCC) who are scheduled for TransOral Robotic Surgery (TORS) and neck dissection. Specific eligibility criteria details were not provided, so it's important to consult the study team for more information on who can participate.Inclusion Criteria
Patients must sign an informed consent document that indicates they are aware of the investigational nature of the treatment in this protocol as well as the potential risks and benefits
My cancer in the throat or neck is confirmed as squamous cell carcinoma.
Ability to understand and the willingness to provide written informed consent
+4 more
Exclusion Criteria
I have had radiation therapy to my head or neck before.
I have had chemotherapy for head and neck cancer.
Known history of hypersensitivity to lidocaine or other amide local anesthetics
+4 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Intervention
Intratumoral lidocaine injection or no injection at the time of direct laryngoscopy prior to TORS and neck dissection
1 day
1 visit (in-person)
Treatment
Participants receive institutional standard of care treatment which may include primary surgery or primary radiation
Varies based on treatment
Follow-up
Participants are monitored for safety and effectiveness after treatment
2 years
Participant Groups
The trial is testing if injecting lidocaine directly into the tumor before surgery can help treat OPSCC. Researchers want to see if this approach is safe and improves outcomes like local control of cancer, survival without disease progression, prevention of metastasis, and overall survival rates.
2Treatment groups
Experimental Treatment
Active Control
Group I: Lidocaine Injectible productExperimental Treatment1 Intervention
Intratumoral injection of 1% lidocaine at the time of direct laryngoscopy.
Group II: Control Arm - No InjectionActive Control1 Intervention
No injection at the time of direct laryngoscopy.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Abramson Cancer Center at University of PennsylvaniaPhiladelphia, PA
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Who Is Running the Clinical Trial?
Ryan CareyLead Sponsor
References
Intravenous lidocaine infusion compared to thoracic epidural analgesia in cytoreductive surgery with or without heated intraperitoneal chemotherapy. A retrospective case-cohort study. [2023]Intravenous (IV) lidocaine is a proven analgesic therapy but has not been evaluated in extensive procedures such as cytoreductive surgery (CRS). Our aim was to assess the effectiveness and safety of IV lidocaine in this setting.
Radioprotective effect of lidocaine on function and ultrastructure of salivary glands receiving fractionated radiation. [2022]Radiation-induced xerostomia still represents a common side effect after radiotherapy for head-and-neck malignancies. The aim of the present study was to examine the radioprotective effect of lidocaine hydrochloride during fractionated radiation in an experimental animal model.
Evaluation of intravenous lidocaine in head and neck cancer surgery: study protocol for a randomized controlled trial. [2020]Pain after major head and neck cancer surgery is underestimated and has both nociceptive and neuropathic characteristics. Extended resection, flap coverage, nerve lesions, inflammation, and high-dose opioid administration can also lead to hyperalgesia and chronic postoperative pain. Opioids are frequently associated with adverse events such as dizziness, drowsiness, nausea and vomiting, or constipation disturbing postoperative recovery and extending the length of hospital stay. Patients eligible for major head and neck cancer surgery cannot benefit from full multimodal pain management with locoregional anesthesia. Intravenous lidocaine, investigated in several studies, has been found to decrease acute pain and morphine consumption. Some data suggest also that it can prevent chronic postsurgical pain. Evidence supporting its use varies between surgical procedures, and there is no published study regarding systemic lidocaine administration in major head and neck cancer surgery. We hypothesized that intravenous lidocaine infused in the perioperative period would lead to opioid sparing and chronic postsurgical pain reduction.
Perioperative Intravenous Lidocaine and Metastatic Cancer Recurrence - A Narrative Review. [2021]Cancer is a major global health problem and the second leading cause of death worldwide. When detected early, surgery provides a potentially curative intervention for many solid organ tumours. Unfortunately, cancer frequently recurs postoperatively. Evidence from laboratory and retrospective clinical studies suggests that the choice of anaesthetic and analgesic agents used perioperatively may influence the activity of residual cancer cells and thus affect subsequent recurrence risk. The amide local anaesthetic lidocaine has a well-established role in perioperative therapeutics, whether used systemically as an analgesic agent or in the provision of regional anaesthesia. Under laboratory conditions, lidocaine has been shown to inhibit cancer cell behaviour and exerts beneficial effects on components of the inflammatory and immune responses which are known to affect cancer biology. These findings raise the possibility that lidocaine administered perioperatively as a safe and inexpensive intravenous infusion may provide significant benefits in terms of long term cancer outcomes. However, despite the volume of promising laboratory data, robust prospective clinical evidence supporting beneficial anti-cancer effects of perioperative lidocaine treatment is lacking, although trials are planned to address this. This review provides a state of the art summary of the current knowledge base and recent advances regarding perioperative lidocaine therapy, its biological effects and influence on postoperative cancer outcomes.
Serum lidocaine concentrations following application to the oropharynx: effects of cimetidine. [2019]Solutions of lidocaine hydrochloride are widely used for anesthesia of the oropharynx and respiratory tract prior to endoscopic procedures. It is commonly believed that this route of administration is not associated with clinically significant systemic absorption of the drug, and large doses of topical lidocaine are routinely used in this setting. Serious adverse effects, including seizures, occasionally occur. The extent of absorption of lidocaine from the oropharynx was studied in eight healthy volunteers. Wide variation in serum lidocaine concentrations was observed. A 14-fold range of peak lidocaine concentrations occurred following identical, accurately metered doses of a lidocaine aerosol spray preparation. The effects of cimetidine on lidocaine pharmacokinetics were also studied. Therapeutic doses of oral cimetidine significantly increased the area under the lidocaine time-concentration curve (p = 0.019), but no effect on the terminal-phase elimination rate constant was observed. Serum concentrations of alpha 1-acid glycoprotein, a major binding protein of lidocaine, were significantly elevated following cimetidine (p = 0.030). Maximum lidocaine concentration, time to reach maximum concentration, and mean residence time of lidocaine were unchanged following cimetidine. These observations suggest an effect of cimetidine on the volume of distribution of lidocaine. Because of the wide variability in lidocaine pharmacokinetics and the potentially serious nature of adverse reactions, caution is advised in the use of topical lidocaine solutions in "standard" doses.
Systemic Lidocaine Infusions for Pediatric Patients with Cancer-Related Pain. [2022]Pediatric patients with cancer experience significant distress from both treatment and cancer-related pain. Careful selection of an analgesic regimen should be based upon individual patient factors, including the level of pain, response to therapy, and physiologic profile. Refractory pain is a therapeutic dilemma frequently encountered in the pediatric cancer setting. Systemic lidocaine infusions have been described as both safe and efficacious, as prior studies show patients reporting decreased pain scores and improved quality of life after lidocaine treatment. Given the favorable side effect profile of lidocaine, it has the potential to be considered for analgesia in the setting of refractory pain. This review discusses the use of systemic lidocaine infusions for analgesia in pediatric oncology patients with cancer-related pain.
Mental Nerve Blocks for Lip Brachytherapy: A Case Report. [2021]High dose rate interstitial brachytherapy is a commonly performed procedure for carcinoma of the lower lip. Placement of the brachytherapy catheters can be painful and may require monitored anesthesia care or general anesthesia. We present the use of bilateral mental nerve blocks with minimal sedation to facilitate placement of brachytherapy catheters.
[Means of improvement of surgical treatment for oropharyngeal planocellular carcinoma]. [2013]A new technique of intraoperative bolus-assisted administration of chemical drugs for oropharyngeal carcinoma has been developed. In tongue tumor, the lingual artery was ligated at the site of origin from the external carotid artery and catheter was installed after venous flow was blocked. Bolus was used to administer 5-fluorouracyl intraoperatively before and after removal of primary tumor. The external carotid artery was ligated at a site above the origin of the upper thyroid artery after venous flow was blocked and paracervical fat excised when tumor site was at the back of the oral cavity, oropharynx or in cases of locally advanced cancer. Subsequently, depending on tumor site, catheter was installed into the external carotid artery trunk at a site below the origin of the lingual artery, the external carotid artery was ligated once more at a site above the origin of the facial artery, and bolus was used to administer 5-fluorouracyl intraoperatively before and after removal of primary tumor. According to the end results, relapse occurred after 28 months instead of 12 and survival improved within the first 2 years after surgery.
Useful combination of intra-arterial chemotherapy and radiation therapy for lateral oropharyngeal wall cancer. [2008]A concomitant treatment of intra-arterial chemotherapy and radiation therapy is a promising therapeutic option for oropharyngeal cancers.
The effect of intraarterial high-dose cisplatin on lymph nodes in oral and oropharyngeal cancer. [2022]To assess the effect of strictly local treatment [intraarterial chemotherapy (iaCHT) with high-dose cisplatin and parallel neutralization] in the primary oral and oropharyngeal cancer (OOSCC) on the dependent cervical lymph nodes.
[Carcinoma of the oropharynx extended to the base of the tongue: radiosurgical treatment with intraoperative radiotherapy]. [2006]Treatment by surgery and postoperative radiotherapy is classical for patients with locally advanced oropharyngeal carcinoma. The poor prognosis of these tumors is associated with the frequency of locoregional relapses, and the survival of the patients treated is more limited according to the initial degree of tumoral involvement of the base of the tongue, which is a critical zone: at this level, the surgical resection must not be too large for a good preservation of the function of the tongue; high doses of radiotherapy are also required here for a fair local tumor control. Intraoperative Radiotherapy (IORT) may be available for delivery of high boosting doses of radiotherapy locally in this target volume. Between March 1988 and March 1992, 39 patients were treated for T3-T4 locally advanced oropharyngeal carcinoma, with 1/4 to 1/2 of the base of the tongue involved; 30 patients were treated for a first localization. Surgery was done by transmaxillary buccopharyngectomy (followed by vascularized myocutaneous flap) for 31 patients with lateral tumors; for 8 patients with median tumor (valleculae), either a conservative susglottic laryngectomy (5 patients) or a total laryngectomy was indicated. Patients treated for the first time underwent also a bilateral node dissection. IORT delivered 20 Gy in the target volume of the resected base of the tongue (prescribed at 90% isodose depth) by the mean of an electron beam of 6 to 13 MeV, with a collimator of 4 or 5 cm of inner diameter. Postoperative radiotherapy was indicated for all patients treated with a first localization. After a minimal follow-up of 6 months, the global survival of 28 patients treated for their first localization was 49% at more than 3 years; 64% of patients treated were locally free of disease. In the same delay, and according to the quality of the surgical resection, the survival of patients treated was 67% and 58%, respectively, if non pathological level of resection was beyond 2 mm, or unless 2 mm from the tumor limit. No complication directly related to IORT was noted. These therapeutic results demonstrate the validity of IORT as a part of a radiosurgical treatment indicated for patients with locally advanced oropharyngeal carcinomas. A longer follow-up of patients treated with a first oropharyngeal tumor is warranted for confirmation of the gain on survival observed.