Cryotherapy for Esophageal Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment involving cryotherapy, which uses extreme cold to target cancer cells, for individuals with locally advanced esophageal cancer. The researchers aim to determine the safest dose of cryotherapy when combined with standard treatment and assess its potential to enhance the immune system's ability to fight cancer. Participants will receive cryotherapy on different schedules before and during their regular treatment to identify the most effective approach. Eligible participants have esophageal cancer that hasn't spread and are experiencing difficulty swallowing. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
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 prior data suggests that liquid nitrogen spray cryotherapy is safe for esophageal cancer patients?
Research has shown that cryotherapy is generally safe and well-tolerated for treating esophageal cancer. Studies have found that most side effects are mild, including chest discomfort or some bleeding in the esophagus. Even for advanced esophageal cancer, cryotherapy appears safe and manageable. Importantly, no severe side effects have been commonly reported, suggesting that this treatment could be a good option for those who qualify.12345
Why do researchers think this study treatment might be promising?
Researchers are excited about cryotherapy for esophageal cancer because it introduces a unique way to tackle tumor cells using extreme cold. Unlike standard treatments like surgery, chemotherapy, or radiation, cryotherapy uses liquid nitrogen to freeze and destroy cancerous tissues. This method might offer a less invasive option with potentially fewer side effects. Additionally, when combined with chemoradiation, cryotherapy could enhance the effectiveness of traditional treatments by weakening the cancer cells, making them more susceptible to subsequent therapies.
What evidence suggests that cryotherapy might be an effective treatment for esophageal cancer?
Research shows that cryotherapy, particularly with liquid nitrogen spray, may help treat esophageal cancer. In this trial, participants will receive cryotherapy in one of two ways: either two sessions before starting chemoradiation or two sessions before and one session during chemoradiation. An early study found that 56% of patients who had one session of cryotherapy before starting chemoradiation experienced a complete response, compared to the usual 25-30% response rate with just chemoradiation. Other studies have found that cryotherapy is safe and can improve quality of life and ease swallowing problems. It works by freezing and killing cancer cells and might also help the immune system fight cancer. Overall, early evidence suggests cryotherapy could be a useful addition to standard treatments for esophageal cancer.13678
Who Is on the Research Team?
Tilak Shah, MD
Principal Investigator
McGuire VA Medical Center
Are You a Good Fit for This Trial?
Adults with locally advanced esophageal cancer, confirmed by specific tests and without distant metastases. They must be able to undergo procedures required for the trial and not have severe coagulopathy, a very poor performance status (ECOG ≥3), or be pregnant.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Cryotherapy
Participants receive 2 sessions of liquid nitrogen spray cryotherapy prior to chemoradiation
Chemoradiation
Participants undergo concurrent chemoradiation for 5 weeks, with additional cryotherapy sessions depending on the group
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of adverse events and quality of life
What Are the Treatments Tested in This Trial?
Interventions
- Cryotherapy
Cryotherapy is already approved in European Union, United States, Canada for the following indications:
- Pain relief
- Inflammation reduction
- Muscle spasm treatment
- Rheumatoid arthritis
- Stress and anxiety relief
- Pain management
- Muscle soreness reduction
- Recovery after exercise
- Fibromyalgia treatment
- Skin health improvement
- Pain relief
- Inflammation reduction
- Muscle spasm treatment
- Arthritis management
- Postpartum recovery
Find a Clinic Near You
Who Is Running the Clinical Trial?
Hunter Holmes Mcguire Veteran Affairs Medical Center
Lead Sponsor
McGuire Research Institute
Collaborator