Quality of Life Assessment of Cryotherapy in Esophageal or Gastroesophageal Cancer

Quality of Life Assessment in Patients Receiving Cryotherapy in Addition to Chemotherapy for Palliation of Unresectable Esophageal or Gastroesophageal Cancer

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03285035

Acronym

Cryotherapy

Enrollment

Registered

2017-09-15

Start date

2017-07-13

Completion date

2021-01-13

Last updated

2019-10-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Cancer

Keywords

Cryotherapy, Palliation, Dysphagia

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.

Interventions

DEVICEAdministration 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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 99 Years

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Number of participants with adverse events as assessed by CTCAE 4.03.	30 days
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
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
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
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
Immunoassays will be obtained before and after treatment	1 year

Countries

United States

Contacts

Primary ContactStudy Coordinator

WesternTrials@ctca-hope.com623-207-3000

Backup ContactResearch Nurse, RN