Clinical trial NCT06876454: Optimal Nutritional Palliation of Obstructed GEJ Cancer
Official title: Optimal Nutritional Palliation of Obstructed GEJ Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Esophageal Cancer
Keywords: metastatic
obstructing
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2025-03-14
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is a single centre, prospective, feasibility randomized controlled clinical trial.
Primary purpose: TREATMENT

Brief summary: The main goal of this trial is to assess whether it's feasible to conduct a larger, full-scale study comparing the use of gastrostomy (g-tubes) and stents in patients with unresectable cancer of the stomach and/or esophagus, and to evaluate their impact on patients' quality of life. Additional objectives include examining the rates of complications, the need for additional treatments, and the total number of hospital days over a three-month period.


Eligibility criteria: Inclusion Criteria:

* Patients aged 18 years of age and older who present with an obstructing metastatic or unresectable gastroesophageal cancer.

Exclusion Criteria:

* Patients under the age of 18 years.
* Prior Esophageal Stent or gastrostomy tube

Primary outcomes:
measure: FACT-E
timeFrame: 3 months
Secondary outcomes:
measure: Complications
timeFrame: 3 months
measure: Crossover
timeFrame: 3 months
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Sciences Centre - Victoria Hospital
state: Ontario
Study officials:
affiliation: London Health Sciences Centre
name: Rahul Nayak, MD MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brenner DR, Weir HK, Demers AA, Ellison LF, Louzado C, Shaw A, Turner D, Woods RR, Smith LM; Canadian Cancer Statistics Advisory Committee. Projected estimates of cancer in Canada in 2020. CMAJ. 2020 Mar 2;192(9):E199-E205. doi: 10.1503/cmaj.191292. Epub 2020 Mar 2.
citation: Kakuta T, Kosugi SI, Ichikawa H, Hanyu T, Ishikawa T, Kanda T, Wakai T. Palliative interventions for patients with incurable locally advanced or metastatic thoracic esophageal carcinoma. Esophagus. 2019 Jul;16(3):278-284. doi: 10.1007/s10388-019-00665-0. Epub 2019 Apr 4.
citation: Philips P, North DA, Scoggins C, Schlegel M, Martin RC. Gastric-Esophageal Stenting for Malignant Dysphagia: Results of Prospective Clinical Trial Evaluation of Long-Term Gastroesophageal Reflux and Quality of Life-Related Symptoms. J Am Coll Surg. 2015 Jul;221(1):165-73. doi: 10.1016/j.jamcollsurg.2015.01.062. Epub 2015 Feb 28.
citation: Yu FJ, Shih HY, Wu CY, Chuang YS, Lee JY, Li HP, Fang PT, Tsai DL, Chou SH, Wu IC. Enteral nutrition and quality of life in patients undergoing chemoradiotherapy for esophageal carcinoma: a comparison of nasogastric tube, esophageal stent, and ostomy tube feeding. Gastrointest Endosc. 2018 Jul;88(1):21-31.e4. doi: 10.1016/j.gie.2017.11.030. Epub 2017 Dec 7.
citation: Madhusudhan C, Saluja SS, Pal S, Ahuja V, Saran P, Dash NR, Sahni P, Chattopadhyay TK. Palliative stenting for relief of dysphagia in patients with inoperable esophageal cancer: impact on quality of life. Dis Esophagus. 2009;22(4):331-6. doi: 10.1111/j.1442-2050.2008.00906.x.
citation: Amin S, Lin C. Immunotherapy Plus Chemoradiation Improves Overall Survival in Stage IV Esophageal Cancer: A Cohort Study. Gastro Hep Adv. 2023 Dec 12;3(3):302-310. doi: 10.1016/j.gastha.2023.12.004. eCollection 2024.