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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the best way to ensure adequate nutrition for people with esophageal cancer during treatment. It compares two approaches: placing a percutaneous feeding tube directly into the stomach or small intestine, and not using a feeding tube at all. The goal is to determine which method helps patients better tolerate chemotherapy and radiation without causing complications. Individuals with esophageal cancer scheduled for specific treatments might be suitable candidates. The trial seeks a safer and more effective method to support nutrition during cancer treatment. As an unphased trial, it offers patients the chance to contribute to important research that could enhance nutritional support during cancer treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that using a feeding tube for patients with esophageal cancer carries some risks. One study found that while placing these tubes is consistently successful, complications can still occur. Specifically, 1.6% of patients experienced major issues, and 10.7% had minor problems, resulting in a total complication rate of 12.3%. Some tubes can become dislodged or infected, potentially requiring additional medical care or surgery.

Another study found that gastrostomy tubes, a type of feeding tube, often result in worse outcomes compared to jejunostomy tubes. These issues can delay treatment and may necessitate emergency visits or hospital stays.

These findings indicate that the safety of feeding tubes in this context is somewhat mixed. While they can aid in nutrition, they might also lead to other health issues. Patients should weigh the benefits and risks and discuss them with their healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the nutritional support options for esophageal cancer because they offer different approaches to managing patient nutrition. Unlike the standard approach, which often involves placing a feeding tube, one treatment arm of this study explores the possibility of managing nutrition without any feeding tube placement. This approach could potentially reduce the risks and discomfort associated with surgical procedures and tube maintenance. On the other hand, the use of percutaneous feeding tubes, such as gastrostomy (G-) tubes or gastrojejunostomy (GJ-) tubes, provides a direct method to ensure adequate nutritional intake, which is crucial for patients unable to swallow due to the cancer. These options might offer tailored nutritional strategies that enhance the quality of life for esophageal cancer patients.

What evidence suggests that this trial's treatments could be effective for esophageal cancer?

Research shows that inserting a feeding tube directly into the stomach or small intestine can help patients with esophageal cancer maintain good nutrition. In this trial, some participants will receive percutaneous enteral access, which involves placing a feeding tube. Studies indicate that this method helps patients better tolerate treatments like chemotherapy and radiation, improving their quality of life. It also supports better long-term survival compared to methods like stents. However, feeding tubes can sometimes cause problems such as infections or blockages, which might require additional medical care. Despite these risks, maintaining nutrition during cancer treatment offers significant benefits. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10586218/

Impact of Percutaneous Endoscopic Gastrostomy Tube ... In the IG, PEG-tube placement success rate was 100%. Pre-procedural oesophageal dilation was necessary in 11 patients (37.9%). 89.3% patients ...

2. ar.iiarjournals.org ar.iiarjournals.org/content/39/8/4243

Efficacy of Percutaneous Endoscopic Gastrostomy for ... This study aimed to clarify the benefits and disadvantages of percutaneous endoscopic gastrostomy (PEG) for patients with esophageal cancer (EC) during ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31025103/

Comparison of Introducer Percutaneous Endoscopic ... In esophageal cancer treatment, nutrition by feeding tube has been demonstrated to improve patient tolerance of treatment, quality of life, and long-term ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1051044321010563

Percutaneous Gastrostomy Compared with Esophageal ... Compared with stent insertion, PG is associated with better maintenance of nutritional status, fewer complications, and better survival.

5. jgo.amegroups.org jgo.amegroups.org/article/view/89790/html

Risk factors contributing to morbidity associated with feeding ... The most common grade of complication was IIIA for complications requiring IR reintervention (43% for G-tubes, 53% for J-tubes) followed by ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0899707118300019

Thirty-day complication rate of percutaneous ... Primary technical success was 100%. Nine major (1.6%) and 60 minor (10.7%) complications occurred for an overall complication rate of 12.3%. The 30-day ...

7. frontiersin.org frontiersin.org/journals/nutrition/articles/10.3389/fnut.2025.1521239/full

The impact of percutaneous endoscopic gastrostomy on ... The median survival for the PEG group was 38.0 months (range, 6.0–60.3), and for the Non-PEG group, it was 43.5 months (range, 21.5–162.8).

8. journals.lww.com journals.lww.com/10.14309/01.ajg.0001131664.00443.25

S1051 Higher Risks With Gastrostomy Tube Placement ... Conclusion: Compared to jejunostomy, gastrostomy tube placement was associated with significantly worse clinical outcomes and higher resource utilization. Given ...