Study on Liquid Nitrogen Spray Cryotherapy Before Chemotherapy for Esophageal Cancer

Sponsor: Case Comprehensive Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT07222657

This clinical trial is exploring whether using liquid nitrogen spray cryotherapy (LNSC) before chemotherapy can improve treatment outcomes for patients with locally advanced esophageal adenocarcinoma. Participants will be randomly assigned to receive either LNSC and chemotherapy or chemotherapy alone.

Patient Parameters

Program Overview

The purpose of this study is to find out if adding liquid nitrogen spray cryotherapy (LNSC) to chemotherapy can better treat esophageal adenocarcinoma, a type of cancer in the esophagus. LNSC is a treatment that uses liquid nitrogen to freeze and damage cancer cells. Participants will be randomly placed into two groups: one receiving LNSC and chemotherapy, and the other receiving only chemotherapy. The study will last about 4 months.

Description

Esophageal adenocarcinoma is a type of cancer that occurs in the esophagus, often causing difficulty swallowing due to the tumor's size. Doctors use various methods like endoscopy and imaging to diagnose and stage the cancer. Treatment usually involves chemotherapy and surgery if possible. However, the response to initial treatments is often low, with only about 25-30% of patients showing a complete response. This study aims to see if adding liquid nitrogen spray cryotherapy (LNSC) can improve these outcomes.

LNSC is a method that uses liquid nitrogen to freeze and destroy abnormal tissue in the esophagus. It works by rapidly cooling the cancerous tissue, causing the cells to die. This treatment is already approved for use in certain esophageal conditions and has shown promise in improving quality of life and treatment response in previous studies.

In this study, participants will be randomly assigned to receive either LNSC along with chemotherapy or chemotherapy alone. Those in the LNSC group will undergo two sessions of the treatment through an endoscopy, a procedure where a thin tube is passed down the throat to reach the esophagus. The study will help determine if LNSC can enhance the body's immune response and improve treatment outcomes for esophageal cancer.

Eligibility Criteria

Inclusion Criteria

  • Adults with locally advanced esophageal adenocarcinoma who are expected to receive chemotherapy with or without Durvalumab.
  • Cancer must be at specific stages as determined by medical imaging and tests.

Exclusion Criteria

  • Unable to insert a tube into the stomach for the procedure.
  • Blood clotting issues or low platelet count.
  • Unable to give informed consent.
  • Poor overall health status as measured by a specific performance scale.
  • High risk of blood clots that prevents stopping certain blood-thinning medications before the procedure.

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