Esophageal CancerNCT05314946
Nutritional Support During Induction Therapy for Esophageal Cancer
A study testing No feeding tube placed and Placement of a percutaneous feeding tube in people with Esophageal Cancer and Nutrition Aspect of Cancer, run by Mehdi Qiabi at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Cancer, Nutrition Aspect of Cancer
- What is being tested?
- No feeding tube placed and Placement of a percutaneous feeding tube
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteCanada
- Study dates
- 1 Nov 2022to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
London Health Sciences Centre - Victoria Hospital
London, Ontario, N6A 5W9
Mehdi Qiabi, MD MSc
Richard A Malthaner, MD MSc
About this study
Official title: Nutritional Support in Patient Undergoing Induction Therapy for Esophageal Cancer
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.
Read the detailed description
Esophageal cancer is highly lethal. In Ontario in 2020, an estimated 900 patients were diagnosed with esophageal cancer, while 860 died from it. In Canada, the figures are 2400 diagnoses and 2260 deaths. The incidence of esophageal cancer in Canada is projected to increase over time, especially in males who are more likely to be obese and to suffer from reflux disease.
Esophageal cancer is the malignancy associated with the highest risk for malnutrition. Before their diagnosis, 80% of all patients with esophageal cancer have over 10-15% unintentional weight loss. Strategies to palliate malnutrition in cancer patients and its consequences on outcomes have been developed. In patient with severe nutritional risk, use of nutritional support for at least 10-14 days has been recommended in a non-surgical, oncology population. The European Society for Clinical Nutrition and Metabolism have recommended preoperatively enteral nutrition for 5-7 days in cancer patients undergoing major abdominal surgery. In addition, dietary counselling and oral nutritional supplement were suggested to prevent weight loss and interruption of radiotherapy on patients undergoing radiation treatments for head/neck or gastrointestinal malignancies. Routine enteral nutrition was not suggested during chemotherapy-only treatments.
The type of supplements administered may have an impact on recovery. It was shown that esophageal cancer patients receiving enriched glutamine, fibers and oligosaccharide perioperative enteral supplementation had a shorter systemic inflammatory response syndrome postoperatively and less surgical stress, which could in turn lead to reduced postoperative immunosuppressive conditions. A recent retrospective study from Taiwan did show a slightly improved 4-year overall survival rate and less mucositis on patients supported by enteral feeding tubes with esophageal squamous cell carcinoma and undergoing neoadjuvant therapy.
However, there is still equipoise in the literature and most centers in Canada have moved away from feeding tubes. At LHSC, feeding tubes were historically placed on every patient during their induction treatment. Efforts are being made to spare patients from unnecessary procedure, but patient selection is variable. Standardization of this practice is needed. A recent retrospective study evaluating the effect of surgical enteral access prior to induction treatment did not show nutritional or perioperative benefit. There was no difference in postoperative complication rates and weight loss was similar. In fact, dysphagia is felt to be significantly relieved after a single cycle of chemotherapy. Percutaneous feeding tubes may not be required on all patients during induction therapy for esophageal cancer.
Those feeding tubes are associated with high morbidity. Kidane et al have shown that 39.3% of visits to the ED after an esophagectomy are due to feeding tubes problems (dislodgement, blockage, infection). Of those ED visits for feeding tubes issues, 17% resulted to an admission. Small bowel obstruction is also associated to percutaneous feeding tube placement and selective use has been recommended. Perioperative use of feeding jejunostomy in gastroesophageal cancer has been associate with a complication rate as high as 44%. Given the related-morbidity, guidelines now recommend selective use of feeding tubes on high-risk patients after esophagectomy. When patients undergoing chemotherapy present to the emergency department with fever or infectious signs, data from the Ontario Cancer Registry show that 46% are admitted, increasing healthcare burden. At baseline, patients undergoing chemotherapy are at high risk of presenting to the emergency department or having unplanned visit to the cancer center, this figure going as high as 49% within 4 weeks of initiation of chemotherapy in comparable jurisdictions. Efforts must be made to save an already strained system.
According to the 2020 Surgical Quality Indicator Report Summary from OH-CCO, our center has the worst 30-day unplanned ED visit rate (45%, provincial mean 27%) after esophagectomy in the province of Ontario. Anecdotally, it is felt that most of those cases are related to feeding tubes complications. If these patients present to the ED due to feeding tubes concerns after an esophagectomy, it is likely they would have presented during induction treatment if they had a tube.
Alternative to feeding tubes exist (home IV hydration) which could become a less invasive and more interesting solution.
The objective of this study is to assess the feasibility of a larger randomized controlled trial evaluating unplanned visit to the ED or the outpatient clinic in patients eligible for trimodality for esophageal cancer during their induction treatment, randomized into receiving percutaneous enteral access for nutritional support versus not.
- Conditions
- Esophageal Cancer, Nutrition Aspect of Cancer
- Being tested
- No feeding tube placed, Placement of a percutaneous feeding tube
- Keywords
- cancer, esophagus, enteral nutrition, feeding tube, adverse events, randomized controlled trial, feasibility
- Medical subject headings
- Esophageal Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No feeding tube placedProcedure or surgery
The experimental arm will forego placement of a feeding tube.
Placement of a percutaneous feeding tubeProcedure or surgery
The standard arm will have a feeding tube placed (G-tube or GJ-tube by IR; or surgically placed J-tube)
| Study group | Role | What they receive |
|---|---|---|
| Percutaneous enteral access | Active comparator | Feeding tube, either gastrostomy (G-) tube or gastrojejunostomy (GJ-) tube (placed by Interventional Radiology) or J-tube (surgically placed) Receives: Procedure: Placement of a percutaneous feeding tube |
| No percutaneous enteral access | Experimental | No feeding tube placed. Receives: Procedure: No feeding tube placed |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From randomization to 90-day post-operative
Secondary outcomes (12)
Rate of unplanned visits (ED or outpatient clinic)
Rate of unplanned visits (ED or outpatient clinic) from randomization to esophagectomy
Measured: From randomization to 90-day post-operative
Time from PET scan to beginning of induction treatment
Measured: From randomization to 90-day post-operative
Total weight loss (kilograms)
Change in kilograms from baseline measured at each visit
Measured: From randomization to 90-day post-operative
Nutritional status
Measured using serum albumin
Measured: From randomization to 90-day post-operative
Any grade adverse event rate
Measured: From randomization to 90-day post-operative
Interruption or dose-reduction of the induction treatment
Measured: From randomization to 90-day post-operative
Rate of completion of planned induction treatment
Measured: From randomization to 90-day post-operative
Quality of life using the Health Related Quality of Life Functional Assessment of Cancer Therapy - Esophageal (HRQOL FACT-E) questionnaire
Higher scores for the scales and subscales indicate better quality of life
Measured: From randomization to 90-day post-operative
Quality of life using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Oesophago-gastric 25 (EORTC QLQ-OG25) questionnaire
A high score on the functional scales or the global quality of life scale indicates a high function or high level of global quality of life, conversely a high score on a symptom scale represents a high level (severity or frequency, depending on the specific question) of the symptom in question.
Measured: From randomization to 90-day post-operative
Quality of life using the EuroQOL 5 Dimensions 3 Levels (EQ-5D-3L) questionnaire
The maximum score of 1 indicates the best health state, by contrast with the scores of individual questions, where higher scores indicate more severe or frequent problems.
Measured: From randomization to 90-day post-operative
Post-operative morbidity
Measured: From surgery to 90-day post-operative
Post-operative mortality
Measured: From surgery to 90-day post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2022
- Study start1 Nov 2022
- Primary completion30 Sep 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mehdi Qiabi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mehdi Qiabi, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05314946
- Sponsor's protocol ID
- HSREB #120816
- Status last verified
- Apr 2024
- First submitted
- 5 Mar 2022
- Last updated
- 3 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Support in Patient Undergoing Induction Therapy for Esophageal Cancer
- ClinicalTrials.gov ID
- NCT05314946
- Acronym / sponsor ID
- HSREB #120816
- Conditions
- Esophageal Cancer, Nutrition Aspect of Cancer
- Keywords
- cancer, esophagus, enteral nutrition, feeding tube, adverse events, randomized controlled trial, feasibility
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Mehdi QiabiUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 7 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Esophageal cancer is highly lethal. In Ontario in 2020, an estimated 900 patients were diagnosed with esophageal cancer, while 860 died from it. In Canada, the figures are 2400 diagnoses and 2260 deaths. The incidence of esophageal cancer in Canada is projected to increase over time, especially in males who are more likely to be obese and to suffer from reflux disease.
Esophageal cancer is the malignancy associated with the highest risk for malnutrition. Before their diagnosis, 80% of all patients with esophageal cancer have over 10-15% unintentional weight loss. Strategies to palliate malnutrition in cancer patients and its consequences on outcomes have been developed. In patient with severe nutritional risk, use of nutritional support for at least 10-14 days has been recommended in a non-surgical, oncology population. The European Society for Clinical Nutrition and Metabolism have recommended preoperatively enteral nutrition for 5-7 days in cancer patients undergoing major abdominal surgery. In addition, dietary counselling and oral nutritional supplement were suggested to prevent weight loss and interruption of radiotherapy on patients undergoing radiation treatments for head/neck or gastrointestinal malignancies. Routine enteral nutrition was not suggested during chemotherapy-only treatments.
The type of supplements administered may have an impact on recovery. It was shown that esophageal cancer patients receiving enriched glutamine, fibers and oligosaccharide perioperative enteral supplementation had a shorter systemic inflammatory response syndrome postoperatively and less surgical stress, which could in turn lead to reduced postoperative immunosuppressive conditions. A recent retrospective study from Taiwan did show a slightly improved 4-year overall survival rate and less mucositis on patients supported by enteral feeding tubes with esophageal squamous cell carcinoma and undergoing neoadjuvant therapy.
However, there is still equipoise in the literature and most centers in Canada have moved away from feeding tubes. At LHSC, feeding tubes were historically placed on every patient during their induction treatment. Efforts are being made to spare patients from unnecessary procedure, but patient selection is variable. Standardization of this practice is needed. A recent retrospective study evaluating the effect of surgical enteral access prior to induction treatment did not show nutritional or perioperative benefit. There was no difference in postoperative complication rates and weight loss was similar. In fact, dysphagia is felt to be significantly relieved after a single cycle of chemotherapy. Percutaneous feeding tubes may not be required on all patients during induction therapy for esophageal cancer.
Those feeding tubes are associated with high morbidity. Kidane et al have shown that 39.3% of visits to the ED after an esophagectomy are due to feeding tubes problems (dislodgement, blockage, infection). Of those ED visits for feeding tubes issues, 17% resulted to an admission. Small bowel obstruction is also associated to percutaneous feeding tube placement and selective use has been recommended. Perioperative use of feeding jejunostomy in gastroesophageal cancer has been associate with a complication rate as high as 44%. Given the related-morbidity, guidelines now recommend selective use of feeding tubes on high-risk patients after esophagectomy. When patients undergoing chemotherapy present to the emergency department with fever or infectious signs, data from the Ontario Cancer Registry show that 46% are admitted, increasing healthcare burden. At baseline, patients undergoing chemotherapy are at high risk of presenting to the emergency department or having unplanned visit to the cancer center, this figure going as high as 49% within 4 weeks of initiation of chemotherapy in comparable jurisdictions. Efforts must be made to save an already strained system.
According to the 2020 Surgical Quality Indicator Report Summary from OH-CCO, our center has the worst 30-day unplanned ED visit rate (45%, provincial mean 27%) after esophagectomy in the province of Ontario. Anecdotally, it is felt that most of those cases are related to feeding tubes complications. If these patients present to the ED due to feeding tubes concerns after an esophagectomy, it is likely they would have presented during induction treatment if they had a tube.
Alternative to feeding tubes exist (home IV hydration) which could become a less invasive and more interesting solution.
The objective of this study is to assess the feasibility of a larger randomized controlled trial evaluating unplanned visit to the ED or the outpatient clinic in patients eligible for trimodality for esophageal cancer during their induction treatment, randomized into receiving percutaneous enteral access for nutritional support versus not.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Percutaneous enteral access | Active comparator | Procedure: Placement of a percutaneous feeding tubeFeeding tube, either gastrostomy (G-) tube or gastrojejunostomy (GJ-) tube (placed by Interventional Radiology) or J-tube (surgically placed) |
| No percutaneous enteral access | Experimental | Procedure: No feeding tube placedNo feeding tube placed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No feeding tube placedThe experimental arm will forego placement of a feeding tube. | Procedure or surgery | No percutaneous enteral access |
| Placement of a percutaneous feeding tubeThe standard arm will have a feeding tube placed (G-tube or GJ-tube by IR; or surgically placed J-tube) | Procedure or surgery | Percutaneous enteral access |
Primary outcome
Feasibility of the trial
Time frame: From randomization to 90-day post-operative
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.
12 secondary outcomes
Rate of unplanned visits (ED or outpatient clinic)
Time frame: From randomization to 90-day post-operative
Time from PET scan to beginning of induction treatment
Time frame: From randomization to 90-day post-operative
Total weight loss (kilograms)
Time frame: From randomization to 90-day post-operative
Nutritional status
Time frame: From randomization to 90-day post-operative
Any grade adverse event rate
Time frame: From randomization to 90-day post-operative
Interruption or dose-reduction of the induction treatment
Time frame: From randomization to 90-day post-operative
Rate of completion of planned induction treatment
Time frame: From randomization to 90-day post-operative
Quality of life using the Health Related Quality of Life Functional Assessment of Cancer Therapy - Esophageal (HRQOL FACT-E) questionnaire
Time frame: From randomization to 90-day post-operative
Quality of life using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Oesophago-gastric 25 (EORTC QLQ-OG25) questionnaire
Time frame: From randomization to 90-day post-operative
Quality of life using the EuroQOL 5 Dimensions 3 Levels (EQ-5D-3L) questionnaire
Time frame: From randomization to 90-day post-operative
Post-operative morbidity
Time frame: From surgery to 90-day post-operative
Post-operative mortality
Time frame: From surgery to 90-day post-operative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing No feeding tube placed and Placement of a percutaneous feeding tube in people with Esophageal Cancer and Nutrition Aspect of Cancer, run by Mehdi Qiabi at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Deb Lewis (5196858500 ext. 75685, deb.lewis@lhsc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the trial (time frame: From randomization to 90-day post-operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2024.