Clinical trial · Observational
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
NCT03285035CI-TRIAL-00041100CryotherapyunknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Cryoablation combined with chemotherapy on the quality of life of patients with non resectable esophageal or gastroesophageal cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Administration of questionaires to patients receiving an upper endoscopy with cryotherapy in addition to chemotherapy for esophageal cancer palliation. | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Non-operable esophageal cancer
- description
- Cryotherapy treatment
- interventionNames
- Device: Administration of questionaires to patients receiving an upper endoscopy with cryotherapy in addition to chemotherapy for esophageal cancer palliation.
Primary outcomes (1)
- measure
- Change in baseline quality of life (QOL) assessment using a modified EORTC QLQ-OES18 at 6 months compared to baseline
- timeFrame
- 6 months
Secondary outcomes (9)
- measure
- Change in dysphagia score using the 5 point Likert scale at 1 to 2 weeks post-procedure compared to baseline
- timeFrame
- 1 to 2 weeks
- measure
- Number of participants with adverse events as assessed by CTCAE 4.03.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDKachaamy 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. PMID 37268010