Quality of Life Assessment of Cryotherapy in Esophageal or Gastroesophageal Cancer

• Conditions: Esophageal Cancer
• Interventions: Device: Administration of questionaires to patients receiving an upper endoscopy with cryotherapy in addition to chemotherapy for esophageal cancer palliation.

• Registration Number: NCT03285035
• Lead Sponsor: Western Regional Medical Center

Brief Summary

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

Detailed Description

This is a single arm prospective study to determine the effect of cryoablation combined with chemotherapy on the quality of life of patients with non resectable esophageal or gastroesophageal cancer.

Study Timeline

• Study Start: 2017-07-13
• Study First Submitted: 2017-08-28
• Study First Submitted QC: 2017-09-12
• Study First Posted: 2017-09-15
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-08
• Last Update Posted: 2019-10-11
• Primary Completion: 2020-07-13
• Study Completion: 2021-01-13

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non-operable esophageal cancer	Administration of questionaires to patients receiving an upper endoscopy with cryotherapy in addition to chemotherapy for esophageal cancer palliation.	Cryotherapy treatment

Primary Outcome Measures

Name	Time	Method
Change in baseline quality of life (QOL) assessment using a modified EORTC QLQ-OES18 at 6 months compared to baseline	6 months

Secondary Outcome Measures

Name	Time	Method
Change in dysphagia score using the 5 point Likert scale at 1 to 2 weeks post-procedure compared to baseline	1 to 2 weeks
local tumor control will be compared to systemic tumor control	1 year
Number of participants requiring alternative treatments for dysphagia palliation such as stenting, photodynamic therapy or brachytherapy and stenting	1 year
Subjective Global Assessment scale of nutritonal status will be determined at baseline and approximately 3 month intervals.	1 year
Immunoassays will be obtained before and after treatment	1 year
Tumor length in centimeters, endoscopist estimated luminal diameter and endoscopist subjective assessment of size as compared to the prior endoscopy will be determined	1 to 12 weeks
Number of participants with adverse events as assessed by CTCAE 4.03.	30 days
Survival while on cryotherapy and systemic chemotherapy will be measured.	1 year
Change in baseline quality of life (QOL) assessment using a modified EORTC QLQ-OES18 at 1 to 2 weeks compared to baseline	1 year

Trial Locations

Locations (1)

Western Regional Medical Center, Inc.; 🇺🇸 Goodyear, Arizona, United States