Recruiting

Cryotherapy

Sponsor:

Western Regional Medical Center

Code:

NCT03285035

Conditions

Esophageal Cancer

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Administration of questionaires to patients receiving an upper endoscopy with cryotherapy in addition to chemotherapy for esophageal cancer palliation.

Study Details

Brief summary:

Cryoablation combined with chemotherapy on the quality of life of patients with non resectable esophageal or gastroesophageal cancer.

Conditions

Esophageal Cancer

Study ID

NCT03285035

Start date

Jul 13, 2017

Status verified date

Oct, 2019

Completion date

Jan 13, 2021

Anticipated

Primary completion date

Jul 13, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Has esophageal or gastroesophageal cancer and will be receiving chemotherapy
  • Dysphagia score of 1, 2, 3 or 4.
  • Age ≥18 years old
  • American Society of Anesthesiologists (ASA) Physical Status Classification ≤ 4
  • Deemed not a candidate for esophageal cancer surgical resection
  • Female subjects must be either post-menopausal, surgically sterilized, or willing to use an acceptable method of birth control (i.e., total abstinence, birth control pills, an intrauterine device (IUD), diaphragm, progesterone injections or implants, or condoms plus a spermicide) for the duration of the study

Exclusion Criteria:

  • Eastern Cooperative Oncology Group (ECOG) performance status greater than 2
  • Patient who received radiation treatment in the prior 8 weeks
  • Known brain metastases causing cranial nerve deficits which can cause dysphagia
  • Inability to undergo an esophagogastroduodenoscopy (EGD)
  • Pregnant or nursing
  • Surgery or anatomy where capacity of stomach is reduced making cryotherapy contraindicated
  • Patients with tracheoesophageal fistula

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Arms

Non-operable esophageal cancer

Cryotherapy treatment

Interventions

Administration of questionaires to patients receiving an upper endoscopy with cryotherapy in addition to chemotherapy for esophageal cancer palliation.

Upper endoscopy with cryotherapy using liquid nitrogen.

Primary outcome measure

  • Change in baseline quality of life (QOL) assessment using a modified EORTC QLQ-OES18 at 6 months compared to baseline [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Study Coordinator

623-207-3000WesternTrials@ctca-hope.com

Research Nurse, RN

623-207-3000WesternTrials@ctca-hope.com

Locations

Western Regional Medical Center, Inc.

Recruiting

Goodyear, Arizona, United States, 85338

Contacts

Toufic Kachaamy, MD

623-207-3000WesternTrials@ctca-hope.com

More Information

Sponsor

Western Regional Medical Center

Last update posted

Oct 11, 2019

Last verified

Oct, 2019

Keywords

  • Cryotherapy
  • Palliation
  • Dysphagia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Western Regional Medical Center on 2019-10-11.