NCT02606396

Cryotherapy for Malignant Dysphagia in Patients With Advanced Esophageal Cancer

Completed NA Last updated 14 April 2026

What this trial tests

NA trial testing Cryotherapy in Esophageal Adenocarcinoma in 15 participants. Completed in 15 March 2022.

Timeline

19 April 2016

Primary endpoint
15 March 2022

15 March 2022

Quick facts

Lead sponsor	Hunter Holmes Mcguire Veteran Affairs Medical Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	supportive care
Enrollment	15
Start date	19 April 2016
Primary completion	15 March 2022
Estimated completion	15 March 2022
Sites	1 location across United States

Drugs / interventions tested

• Cryotherapy (CRYOTHERAPY) — full drug profile →
• Esophagogastroduodenoscopy (EGD)
• Endoscopic ultrasound (EUS)

Conditions studied

• Esophageal Adenocarcinoma — all drugs for Esophageal Adenocarcinoma →

Sponsor

Hunter Holmes Mcguire Veteran Affairs Medical Center

Who can join

18 and older, any sex, with Esophageal Adenocarcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Esophageal adenocarcinoma (EAC) is one of the few cancers with a rising incidence in the United States, with an estimated 17,000 new cases diagnosed in 2012. Most patients with esophageal cancer present with tumors which are not amenable to surgery and are treated with chemotherapy and radiation. The most common and bothersome symptoms from esophageal cancer is dysphagia (difficulty swallowing). Chemotherapy and radiation are effective in shrinking tumors and allowing patients with EAC to swallow more easily; however it usually takes 1-2 months for swallowing to improve with this treatment.

Another method of shrinking esophageal tumors and allowing for better swallowing is endoscopic spray cryotherapy (freezing the tumor from inside the esophagus with the aid of an endoscope); cryotherapy is a well established method for treating cancerous and pre-cancerous esophageal disease. This is a particularly attractive treatment option, as patients with esophageal cancer usually undergo endoscopy on several occasions before starting treatment in order to biopsy and evaluate the tumor.

The goal of this study is to evaluate the effectiveness of cryotherapy in treating EAC related dysphagia in patients who are getting ready to start chemotherapy and radiation.

In order to do this the investigators are planning to invite patients who are already undergoing endoscopy for pre-chemotherapy evaluation of known EAC. Patients would undergo cryotherapy after the diagnostic portion of the endoscopy has been completed. After the cryotherapy patients will be contacted by phone in order to evaluate change in symptoms, 2 and 4 weeks after cryotherapy.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Neoadjuvant cryotherapy improves dysphagia and may impact remission rates in advanced esophageal cancer.
   Shah T, Kushnir V, Mutha P, Majhail M, et al · · 2019 · cited 18× · PMID 31681831 · DOI 10.1055/a-0957-2798
2. Applications of cryotherapy in premalignant and malignant esophageal disease: Preventing, treating, palliating disease and enhancing immunogenicity?
   Boer LS, Nierkens S, Weusten BLAM. · · 2025 · cited 1× · PMID 40487973 · DOI 10.4251/wjgo.v17.i5.103746