A Study To Examine Quality of Life Assessment in Patients Receiving Cryotherapy for Palliation of Dysphagia in Unresectable Esophageal or Gastroesophageal Junctional Cancer
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Scottsdale/Phoenix, Arizona: 19-000845
Sponsor Protocol Number: 19-000845
About this study
The purpose of this study is to determine the effect of endoscopic cryoablation for lessening the effects of dysphagia on the quality of life (QOL) of patients with unresectable esophageal or gastroesophageal junctional cancer.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Has esophageal or gastroesophageal cancer and expected to receive systemic anticancer therapy.
- Dysphagia score of 1, 2, 3 or 4.
- Age ≥ 18 years old.
- ASA ≤ 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 IUD, diaphragm, progesterone injections or implants, or condoms plus a spermicide) for the duration of the study.
Exclusion Criteria:
- 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 EGD.
- Pregnant or nursing.
- Surgery or anatomy where capacity of stomach is reduced making cryotherapy contraindicated.
- Patients with tracheoesophageal fistula.
- Expected survival less than 3 months.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
Contact |
Scottsdale/Phoenix, Ariz.
Mayo Clinic principal investigator Rahul Pannala, M.D. |
Open for enrollment |
Contact information:
Cancer Center Clinical Trials Referral Office
(855) 776-0015
|
More information
Publications
Publications are currently not available