Nutritional Support During Induction Therapy for Esophageal Cancer
Nutritional Support in Patient Undergoing Induction Therapy for Esophageal Cancer
1 other identifier
interventional
26
1 country
1
Brief Summary
Patients diagnosed with esophageal cancer have difficulty eating, as the food pipe becomes obstructed by the cancer. This may impair the ability for the patient to receive appropriate calorie intake, especially during administration of chemotherapy and radiation therapy given prior to surgical resection. A strategy is to place a feeding tube directly in the stomach or in the small bowel to have an access to the patient's gastrointestinal tract during administration of chemo radiation therapy. However, these feeding tubes may lead to adverse events, including dislodgement, infection, the tube may be plugged, etc. If these complications were to happen, patients may have their treatment delayed, may have to come to the emergency department or even be admitted. In some cases, patients may need to have a surgery performed to treat the complication. Most centres in Canada have moved away from placement of these feeding tubes due to the high incidence of complications associated with the feeding tubes placement, and due to the high efficacy from the chemoradiation therapy in shrinking the tumour, allowing for the patient to swallow. In London, the preference from the Medical and Radiation Oncologists was to have these feeding tubes placed to avoid delay in treating the patients. There is therefore significant controversy as to what is the best approach in this patient population. Our goal is to run a feasibility randomized controlled trial studying this question.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 5, 2022
CompletedFirst Posted
Study publicly available on registry
April 7, 2022
CompletedStudy Start
First participant enrolled
November 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedApril 3, 2024
April 1, 2024
1.9 years
March 5, 2022
April 2, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Feasibility of the trial
The trial will be deemed feasible if 60% or more of eligible patients are recruited, 80% or more of data is collected, and 5% or less patients are lost to follow-up.
From randomization to 90-day post-operative
Secondary Outcomes (12)
Rate of unplanned visits (ED or outpatient clinic)
From randomization to 90-day post-operative
Time from PET scan to beginning of induction treatment
From randomization to 90-day post-operative
Total weight loss (kilograms)
From randomization to 90-day post-operative
Nutritional status
From randomization to 90-day post-operative
Any grade adverse event rate
From randomization to 90-day post-operative
- +7 more secondary outcomes
Study Arms (2)
Percutaneous enteral access
ACTIVE COMPARATORFeeding tube, either gastrostomy (G-) tube or gastrojejunostomy (GJ-) tube (placed by Interventional Radiology) or J-tube (surgically placed)
No percutaneous enteral access
EXPERIMENTALNo feeding tube placed.
Interventions
The experimental arm will forego placement of a feeding tube.
The standard arm will have a feeding tube placed (G-tube or GJ-tube by IR; or surgically placed J-tube)
Eligibility Criteria
You may qualify if:
- Adult patient
- Non-cervical biopsy-proven esophageal or gastroesophageal junction (Siewert I or II) cancer
- Patient eligible for induction therapy then esophagectomy (stage Ib to III)
You may not qualify if:
- Impossibility to pass an endoscope beyond the tumour
- metastatic disease
- early-stage disease with either upfront esophagectomy or endoscopic resection planned
- patient refusal of the feeding tube
- inability to swallow their pill
- inability to tolerate a full fluid diet
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mehdi Qiabilead
Study Sites (1)
London Health Sciences Centre - Victoria Hospital
London, Ontario, N6A 5W9, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate Scientist
Study Record Dates
First Submitted
March 5, 2022
First Posted
April 7, 2022
Study Start
November 1, 2022
Primary Completion
September 30, 2024
Study Completion
December 31, 2024
Last Updated
April 3, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will not share