Quality of Life Assessment of Cryotherapy in Esophageal or Gastroesophageal Cancer

NCT ID: NCT03285035

Last Updated: 2019-10-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-07-13

Study Completion Date

2021-01-13

Brief Summary

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

Detailed Description

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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.

Conditions

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Esophageal Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Non-operable esophageal cancer

Cryotherapy treatment

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

Intervention Type DEVICE

Upper endoscopy with cryotherapy using liquid nitrogen.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Western Regional Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Toufic Kachaamy, MD

Role: PRINCIPAL_INVESTIGATOR

Western Regional Medical Center

Locations

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Western Regional Medical Center, Inc.

Goodyear, Arizona, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Study Coordinator

Role: CONTACT

623-207-3000

Research Nurse, RN

Role: CONTACT

623-207-3000

Facility Contacts

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Toufic Kachaamy, MD

Role: primary

623-207-3000

References

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Kachaamy T, Sharma N, Shah T, Mohapatra S, Pollard K, Zelt C, Jewett E, Garcia R, Munsey R, Gupta S, Rojas-DeLeon M, Gupta D, Kaul V, Pannala R, Vashi P. A prospective multicenter study to evaluate the impact of cryotherapy on dysphagia and quality of life in patients with inoperable esophageal cancer. Endoscopy. 2023 Oct;55(10):889-897. doi: 10.1055/a-2105-2177. Epub 2023 Jun 2.

Reference Type DERIVED
PMID: 37268010 (View on PubMed)

Other Identifiers

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WG2015029

Identifier Type: -

Identifier Source: org_study_id

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