Lidocaine Injection for Oropharyngeal Cancer

(856397 Trial)

Overseen By Prannda Sharma, MS

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Ryan Carey

Disqualifiers: Radiation, Chemotherapy, Metastatic disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Varies based on treatment

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether injecting lidocaine directly into oropharyngeal cancer tumors during surgery aids in treating the cancer. Researchers aim to determine its safety and effectiveness in preventing cancer spread and increasing survival rates. Individuals diagnosed with oropharyngeal squamous cell carcinoma and scheduled for surgery at the University of Pennsylvania may qualify. The study includes two groups: one receives the lidocaine injection, while the other does not, allowing for result comparison. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to receive this innovative approach.

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.

Is there any evidence suggesting that intratumoral lidocaine injection is likely to be safe for humans?

Research has shown that lidocaine, a common local anesthetic, might also help fight cancer. Studies indicate that patients tolerate lidocaine well, particularly when used to manage pain during surgery. For instance, in one study with 60 patients, lidocaine administered intravenously proved as effective as other anesthetics, with no major safety issues.

Injecting lidocaine directly into tumors remains under investigation to determine its safety and effectiveness. This trial is in the early stages, focusing primarily on the safety of tumor injections. While data is limited, the trial closely monitors for any side effects.

Lidocaine's established safety in other medical settings, such as numbing during surgeries, offers some reassurance. However, its specific application in cancer treatment continues to be studied. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for oropharyngeal cancer, which often involve surgery, radiation, and chemotherapy, the intratumoral lidocaine injection is unique because it directly targets the tumor with a local anesthetic. This approach could potentially minimize side effects compared to systemic treatments, as it acts right at the cancer site without affecting the whole body. Researchers are excited about this treatment because lidocaine may disrupt cancer cell signaling and growth, offering a novel mechanism of action. This localized delivery method may also enhance patient comfort and recovery by reducing the need for more invasive procedures.

What evidence suggests that intratumoral lidocaine injection might be an effective treatment for oropharyngeal cancer?

This trial will compare the effects of an intratumoral lidocaine injection with no injection for patients undergoing direct laryngoscopy for oropharyngeal cancer. Studies have shown that lidocaine, a common local anesthetic, might help fight cancer. Research suggests that lidocaine can trigger a process that causes cancer cells to self-destruct and may also help prevent cancer from spreading. Early findings indicate that lidocaine could enhance the effectiveness of traditional chemotherapy. In other studies involving surgery, lidocaine has matched the effectiveness of other pain management methods, suggesting benefits beyond just numbing. While the data is still emerging, these early signs offer a hopeful outlook for using lidocaine in treating oropharyngeal cancer. ^{1 2 3 4 6}

Who Is on the Research Team?

Ryan Carey, MD

Principal Investigator

University of Pennsylvania

Are You a Good Fit for This Trial?

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

Ability to understand and the willingness to provide written informed consent

My cancer in the throat or neck is confirmed as squamous cell carcinoma.

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Intratumoral Lidocaine Injection

Trial Overview 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.

How Is the Trial Designed?

Group I: Lidocaine Injectible product Experimental Treatment 1 Intervention

Intratumoral injection of 1% lidocaine at the time of direct laryngoscopy.

Group II: Control Arm - No Injection Active Control 1 Intervention

No injection at the time of direct laryngoscopy.

Who Is Running the Clinical Trial?

Ryan Carey

Lead Sponsor

Trials

1

Recruited

30+

Published Research Related to This Trial

Lidocaine, a local anaesthetic, has shown potential in laboratory studies to inhibit cancer cell behavior and improve immune responses, suggesting it could reduce the risk of cancer recurrence after surgery.

Despite promising laboratory results, there is currently a lack of strong clinical evidence to confirm the anti-cancer benefits of perioperative lidocaine, although future trials are planned to investigate this further.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perioperative Intravenous Lidocaine and Metastatic Cancer Recurrence - A Narrative Review. Wall, TP., Buggy, DJ.[2021]

A combination of intra-arterial chemotherapy and radiation therapy shows promise as an effective treatment for oropharyngeal cancers, particularly for patients with advanced stages of the disease.

In a study of 73 patients, the 5-year disease-specific survival rates varied by stage, with 100% for stage I and decreasing to 22.2% for stage IVb, highlighting the importance of early detection and treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Useful combination of intra-arterial chemotherapy and radiation therapy for lateral oropharyngeal wall cancer. Tsukahara, K., Yoshida, T., Tokashiki, R., et al.[2008]

In a study of 60 patients undergoing cytoreductive surgery, intravenous lidocaine was found to be as effective as thoracic epidural anesthesia in managing pain, with lower pain scores at 72 hours post-surgery.

Patients receiving intravenous lidocaine had significantly reduced opioid consumption and a lower incidence of postoperative nausea and vomiting (PONV) compared to those receiving thoracic epidural anesthesia, suggesting it may be a safer and more effective analgesic option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intravenous lidocaine infusion compared to thoracic epidural analgesia in cytoreductive surgery with or without heated intraperitoneal chemotherapy. A retrospective case-cohort study. Tejedor, A., Bijelic, L., Polanco, M., et al.[2023]

Bilateral mental nerve blocks combined with minimal sedation can effectively reduce pain during the placement of brachytherapy catheters for lower lip carcinoma treatment.

This approach may decrease the need for more invasive anesthesia methods, such as monitored anesthesia care or general anesthesia, making the procedure safer and more comfortable for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mental Nerve Blocks for Lip Brachytherapy: A Case Report. Hafez, O., Ackerman, RS., Evans, T., et al.[2021]

Intraoperative Radiotherapy (IORT) delivered high doses of radiation (20 Gy) directly to the resected base of the tongue in 39 patients with locally advanced oropharyngeal carcinoma, showing a 49% overall survival rate at over 3 years and 64% of patients were locally free of disease after treatment.

No complications directly related to IORT were reported, indicating that this method is a safe and effective addition to the surgical treatment of oropharyngeal cancers, particularly for patients with significant tumor involvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Carcinoma of the oropharynx extended to the base of the tongue: radiosurgical treatment with intraoperative radiotherapy]. Schmitt, T., Prades, J., Pinto, N., et al.[2006]

A study involving eight healthy volunteers revealed significant variability in serum lidocaine concentrations after using a topical aerosol spray, with a 14-fold difference in peak levels from identical doses, indicating unpredictable absorption rates.

The use of cimetidine, a medication that affects drug metabolism, was found to increase the overall exposure to lidocaine, suggesting that caution should be exercised when using standard doses of topical lidocaine due to the risk of serious adverse effects like seizures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Serum lidocaine concentrations following application to the oropharynx: effects of cimetidine. Parish, RC., Gotz, VP., Lopez, LM., et al.[2019]

Intraarterial chemotherapy (iaCHT) with high-dose cisplatin significantly reduced the uptake of fluor18-deoxyglucose (FDG) in cervical lymph nodes of 17 patients with oral and oropharyngeal cancer, indicating a regional treatment effect.

The study found a significant decrease in SUVmax values for lymph nodes with metastases (P = 0.03) and a notable reduction in all lymph nodes with uptake (P = 0.004), suggesting that iaCHT may effectively target cancerous lymph nodes, although the exact mechanism of action remains unclear.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of intraarterial high-dose cisplatin on lymph nodes in oral and oropharyngeal cancer. Kovács, AF., Döbert, N., Engels, K.[2022]

In an experimental study with rabbits, lidocaine hydrochloride was found to significantly protect salivary gland function during radiation therapy, particularly at a dose of 12 mg/kg, improving tolerance to radiation doses up to 35 Gy.

The study demonstrated that lidocaine not only preserved the functional capacity of the salivary glands but also maintained their ultrastructure, suggesting it could be a promising clinical strategy to prevent xerostomia in patients undergoing radiotherapy for head-and-neck cancers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radioprotective effect of lidocaine on function and ultrastructure of salivary glands receiving fractionated radiation. Hakim, SG., Benedek, GA., Su, YX., et al.[2022]

Systemic lidocaine infusions have been shown to be both safe and effective in reducing pain and improving quality of life in pediatric cancer patients experiencing refractory pain.

The use of lidocaine as an analgesic option is particularly promising due to its favorable side effect profile, making it a viable choice for managing difficult pain cases in children with cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systemic Lidocaine Infusions for Pediatric Patients with Cancer-Related Pain. Rav, E., Sheth, R., Ahmad, AH.[2022]

This study will evaluate the effectiveness of intravenous lidocaine in reducing opioid consumption and chronic postoperative pain in 128 patients undergoing major head and neck cancer surgery, marking the first trial of its kind for this specific procedure.

The hypothesis is that lidocaine will lead to less reliance on opioids post-surgery, potentially minimizing adverse effects associated with opioid use and improving recovery outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of intravenous lidocaine in head and neck cancer surgery: study protocol for a randomized controlled trial. Omar, E., Wallon, G., Bauer, C., et al.[2020]

A new intraoperative technique for administering 5-fluorouracil in patients with oropharyngeal carcinoma showed promising results, with a significant increase in time to relapse from 12 months to 28 months.

Patients experienced improved survival rates within the first 2 years post-surgery, suggesting that this bolus-assisted drug delivery method may enhance treatment efficacy for tongue tumors and advanced oropharyngeal cancers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Means of improvement of surgical treatment for oropharyngeal planocellular carcinoma]. Vikhlianov, IV., Shoĭkhet, IaN., Lazarev, AF.[2013]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06747390

NCT06747390 | Intratumoral Lidocaine Injection Before ... Based on evidence that the local anesthetic lidocaine may have anticancer effects, this study will assess the safety and efficacy of intratumoral lidocaine ...

2. withpower.com withpower.com/trial/lidocaine-injection-for-oropharyngeal-cancer-a25b7

Lidocaine Injection for Oropharyngeal Cancer (856397 Trial) In a study of 60 patients undergoing cytoreductive surgery, intravenous lidocaine was found to be as effective as thoracic epidural anesthesia in managing pain, ...

3. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/90/NCT06747390/Prot_000.pdf

A Phase I Randomized Controlled Trial of Intratumoral Based on evidence that lidocaine may activate apoptosis in cancer cells and/or limit metastasis, this randomized phase I study will establish ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11666215/

The effect of lidocaine infusion in oncologic surgery Lidocaine exhibits significant antitumor effects and potential as a chemosensitizer, enhancing the efficacy of traditional chemotherapy.

5. clinconnect.io clinconnect.io/trials/NCT06747390

Intratumoral Lidocaine Injection Before Oropharyngeal Based on evidence that the local anesthetic lidocaine may have anticancer effects, this study will assess the safety and efficacy of intratumoral lidocaine ...

6. clin.larvol.com clin.larvol.com/trial-detail/NCT06747390

Intratumoral Lidocaine Injection Before Oropharyngeal ... Safety measured by occurrence of adverse events. Adverse events (AE) and Serious Adverse Events (SAE) will use the descriptions and grading scales found in the ...