RecruitingNot ApplicableNCT05314946

Nutritional Support During Induction Therapy for Esophageal Cancer

Nutritional Support in Patient Undergoing Induction Therapy for Esophageal Cancer


Sponsor

Mehdi Qiabi

Enrollment

26 participants

Start Date

Nov 1, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study looks at the best way to provide nutritional support to people with esophageal cancer who are receiving pre-surgery chemotherapy and/or radiation (induction therapy). Patients with esophageal cancer often struggle to eat enough due to tumor obstruction, and proper nutrition can improve treatment outcomes. **You may be eligible if...** - You are an adult with biopsy-confirmed esophageal or gastroesophageal junction cancer (not in the neck/cervical area) - Your cancer is stage Ib–III and you are eligible for induction therapy followed by surgery **You may NOT be eligible if...** - An endoscope cannot pass beyond the tumor (complete obstruction) - Your cancer has spread to distant organs (metastatic) - Your cancer is early stage and will be treated with surgery or endoscopic removal only (no induction therapy) - You refuse a feeding tube - You cannot swallow pills - You cannot tolerate a full liquid diet Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURENo feeding tube placed

The experimental arm will forego placement of a feeding tube.

PROCEDUREPlacement of a percutaneous feeding tube

The standard arm will have a feeding tube placed (G-tube or GJ-tube by IR; or surgically placed J-tube)


Locations(1)

London Health Sciences Centre - Victoria Hospital

London, Ontario, Canada

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NCT05314946


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