Nutritional Support for Esophageal Cancer

Overseen By Mehdi Qiabi, MD MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mehdi Qiabi

Disqualifiers: Metastatic disease, Early-stage disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

26 Participants Needed

Trial Summary

What is the purpose of this trial?

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 Criteria

Adults with non-cervical esophageal or gastroesophageal junction cancer, stages Ib to III, who are set for induction therapy followed by surgery. Excluded are those with metastatic disease, swallowing difficulties that prevent pill intake, tumors blocking endoscope passage, early-stage patients opting for immediate surgery or endoscopic resection, and anyone refusing a feeding tube.

Inclusion Criteria

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)

Exclusion Criteria

Patient refusal of the feeding tube

You have early-stage disease and are planning to have surgery or a minimally invasive procedure to remove the affected area.

You have difficulty swallowing pills.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction Treatment

Participants undergo induction therapy, which includes chemotherapy and radiation therapy, with or without percutaneous enteral access for nutritional support

10-14 days

Multiple visits for chemotherapy and radiation sessions

Follow-up

Participants are monitored for safety, nutritional status, and quality of life after induction treatment

90 days

Regular visits for monitoring and assessments

Treatment Details

Interventions

• No feeding tube placed
• Placement of a percutaneous feeding tube

Trial Overview The trial is examining whether placing a feeding tube in the stomach or small bowel during chemo radiation therapy helps maintain calorie intake without causing delays due to complications like dislodgement or infection versus not using a feeding tube at all.

Participant Groups

Group I: No percutaneous enteral access Experimental Treatment 1 Intervention

No feeding tube placed.

Group II: Percutaneous enteral access Active Control 1 Intervention

Feeding tube, either gastrostomy (G-) tube or gastrojejunostomy (GJ-) tube (placed by Interventional Radiology) or J-tube (surgically placed)

Who Is Running the Clinical Trial?

Mehdi Qiabi

Lead Sponsor

Trials

1

Recruited

30+