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出境医 / 临床实验 / Feasibility Study Comparing Enteral vs Parenteral Nutritional Outcomes in Autologous Stem Cell Transplant Patients
Feasibility Study Comparing Enteral vs Parenteral Nutritional Outcomes in Autologous Stem Cell Transplant Patients
Study Description
Brief Summary:
This study will highlight that Enteral Nutrition (EN) is as effective in nutritionally supporting as Parenteral Nutrition (PN) in this group of patients undergoing an autologous hematopoietic stem cell transplantation (AHSCT). The rationale of this study is to compare nutritional, medical, cost and Quality of Life (QOL) outcomes in patients receiving either EN or PN nutritional support in patients. The main outcomes are to examine are nutritional status, medical complications, cost and QOL before and after AHSCT.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Malignant Hematologic Neoplasm | Procedure: Parenteral Nutrition/Enteral Nutrition | Not Applicable |
Detailed Description:
This will be a pilot open randomized study. The study will be conducted at the inpatient setting at London Health Sciences Centre in London, ON. Forty patients will be randomized in permutated blocks independently by Statistician, to either the EN or PN group on admission to the unit. The baseline evaluations are blood work, Bioelectric Impedance Analysis (BIA), Subjective Global Assessment (SGA), Body Mass Index (BMI) calculation, ultrasound, and a medical evaluation. Patients do have the right to refuse either or both types of nutritional support. As part of standard care, the risks and benefits of nutritional support for both EN and PN will be explained to the patient.
Consent will be obtained prior to admission. Most of these patients initially continue to maintain their oral intake even after chemotherapy. On Day 5+/- 1 day after transplantation, the randomized nutrition therapy will only be initiated only if patient intake is < 80% of usual intake, where they will be provided with 25-35 kcal/kg/day, 1.2-1.5g of protein/kg/day, and omega-3 to supplement any oral intake the patient might not have. If the intake is >80% of required intake, initiation of randomized therapy will only happen on the day the intake falls to <80% of required nutritional intake.
Patients will be monitored until Day 15 where post-transplant evaluations will be conducted: blood work, BIA, SGA, ultrasound, BMI, food records, and medical evaluation. If at that time, patients are not consuming 50% of energy from oral feeds, nutrition therapy will continue until oral goal is met or until discharge for medical reasons. Patients will be assessed at Day+30 post-transplant in clinic and the following will be completed blood work, BIA, SGA, BMI, food records, ultrasound, medical complications and a QOL assessment.
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 40 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | Randomization will be 1:1, both EN and PN arms. The patients will be randomized in permutated blocks independently by Statistician. |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Pilot Feasibility Study of Nutritional Outcomes in Autologous Hematopoietic Stem Cell Transplant Recipients Comparing Enteral Nutrition Versus Parenteral Nutrition |
| Actual Study Start Date : | August 20, 2019 |
| Estimated Primary Completion Date : | August 30, 2020 |
| Estimated Study Completion Date : | December 31, 2020 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
Active Comparator: Parenteral Nutrition
Patients who have been randomized to receive PN will be started on day 5 post AHSCT. This will be if patient intake is < 80% of usual oral intake at that time. The central venous catheter required for PN administration will be already in place for AHSCT treatment, prior to admission and pre-transplant evaluation. Nutritional support will continue until oral intake is >50% or until the patient is ready for discharge if intake remains < 50% of recommendations.
|
Procedure: Parenteral Nutrition/Enteral Nutrition
Patients randomized to the parenteral nutrition arm will receive nutrition by IV and patients randomized to the enteral nutrition arm will receive nutrition by NG tube.
|
|
Experimental: Enteral Nutrition
Patients who have been randomized to receive EN will have a Nasogastric tube (NGT) inserted on day 5 post AHSCT, prior to start of Enteral feeds. This would be a polyurethane tube, 8-10 French, which will be inserted by physician or Nurse Practitioner with position confirmed by radiological examination. This will be if patient intake is < 80% of usual oral intake at that time. Nutritional support will continue until oral intake is >50% or until the patient is ready for discharge if intake remains < 50% of recommendations.
|
Procedure: Parenteral Nutrition/Enteral Nutrition
Patients randomized to the parenteral nutrition arm will receive nutrition by IV and patients randomized to the enteral nutrition arm will receive nutrition by NG tube.
|
Outcome Measures
Primary Outcome Measures :
- Enrollment of patients [ Time Frame: 30 days ]The number of patients enrolled
Secondary Outcome Measures :
- quadriceps muscle layer thickness [ Time Frame: 21 days ]Maintenance and/or improvement of quadriceps muscle layer thickness (QMLT) measurement: measured by ultrasound.
- Duration of Support [ Time Frame: 21 days ]A comparison of duration in days a patient will require enteral or parenteral nutritional support during their admission.
- Changes in costs [ Time Frame: 21 days ]The cost of daily total PN is $80/day and cost of EN feeds would be $40/day. This is a 50% change in costs.
- Hospital Stay [ Time Frame: 21 days ]Length of hospital stay (decrease by 1+/-2 days)
- Mortality [ Time Frame: 30 days ]Mortality on Day+30 Post AHSCT
- Changes in body fat [ Time Frame: 21 Days ]Measuring the changes in percentage of body fat mass using Bioelectric Impedance Analysis
- Changes in Lean Muscle [ Time Frame: 21 Days ]Measuring the changes in percentage lean muscle mass using Bioelectric Impedance Analysis
- Changes in costs to hospital when using enteral nutritional [ Time Frame: 21 Days ]the measurement the length of their stay in the hospital by days, fewer days of hospitalization = lower costs and more days of hospitalization = greater costs
- Transition from EN to oral feeding [ Time Frame: 15 Days ]Successful transition from EN to oral feeding versus Parenteral Nutrition to oral feeding defined by 50% oral intake on Day+15 of AHSCT.
Eligibility Criteria
| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- All adult patients aged 18 to 75 years.
- Patients admitted to Victoria Hospital undergoing AHSCT on C7 unit.
- Patient consented to participate in the study
- Patients diagnosed with the following conditions: Non- Hodgkin's Lymphoma (all types), Hodgkin's Lymphoma (all subtypes) and Multiple Myeloma
- Patients receiving any of the following: Conditioning chemotherapy: Melphalan, Etoposide/Melphalan, or Carmustine, Etoposide, Cytarabine, Melphalan
- Have a functional Gastrointestinal tract
Exclusion Criteria:
- Intestinal obstruction
- Patients with nasal deformities, tumors of nasal tracts or upper nare obstruction.
- Patients with active bacteremia while proceeding with transplant
- Patients with active malignancy of Upper GI tract, not in remission as evidenced by recent imaging studies (< 4 weeks)
- Patients with any GI bleeding, paralytic ileus, obstruction, or any other GI condition which excludes use of the GI system for nutritional support as these patients will require PN feeding only and cannot be randomized
Contacts and Locations
Contacts
| Contact: Uday Deotare, MD | 519-685-8500 ext 58479 | Uday.Deotare@lhsc.on.ca | |
| Contact: Maisam Abouzeenni, BHS | 519-685-8500 ext 56840 | Maisam.Abouzeenni@lhsc.on.ca |
Locations
| Canada, Ontario | |
| London Health Sciences Centre-Victoria Hospital | Recruiting |
| London, Ontario, Canada, N6A 5W9 | |
| Contact: Uday Deotare, MD 519-685-8500 ext 76616 Uday.Deotare@lhsc.on.ca | |
Sponsors and Collaborators
Lawson Health Research Institute
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | April 24, 2019 | ||||||||
| First Posted Date ICMJE | July 18, 2019 | ||||||||
| Last Update Posted Date | March 31, 2020 | ||||||||
| Actual Study Start Date ICMJE | August 20, 2019 | ||||||||
| Estimated Primary Completion Date | August 30, 2020 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Enrollment of patients [ Time Frame: 30 days ] The number of patients enrolled
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Feasibility Study Comparing Enteral vs Parenteral Nutritional Outcomes in Autologous Stem Cell Transplant Patients | ||||||||
| Official Title ICMJE | A Pilot Feasibility Study of Nutritional Outcomes in Autologous Hematopoietic Stem Cell Transplant Recipients Comparing Enteral Nutrition Versus Parenteral Nutrition | ||||||||
| Brief Summary | This study will highlight that Enteral Nutrition (EN) is as effective in nutritionally supporting as Parenteral Nutrition (PN) in this group of patients undergoing an autologous hematopoietic stem cell transplantation (AHSCT). The rationale of this study is to compare nutritional, medical, cost and Quality of Life (QOL) outcomes in patients receiving either EN or PN nutritional support in patients. The main outcomes are to examine are nutritional status, medical complications, cost and QOL before and after AHSCT. | ||||||||
| Detailed Description |
This will be a pilot open randomized study. The study will be conducted at the inpatient setting at London Health Sciences Centre in London, ON. Forty patients will be randomized in permutated blocks independently by Statistician, to either the EN or PN group on admission to the unit. The baseline evaluations are blood work, Bioelectric Impedance Analysis (BIA), Subjective Global Assessment (SGA), Body Mass Index (BMI) calculation, ultrasound, and a medical evaluation. Patients do have the right to refuse either or both types of nutritional support. As part of standard care, the risks and benefits of nutritional support for both EN and PN will be explained to the patient. Consent will be obtained prior to admission. Most of these patients initially continue to maintain their oral intake even after chemotherapy. On Day 5+/- 1 day after transplantation, the randomized nutrition therapy will only be initiated only if patient intake is < 80% of usual intake, where they will be provided with 25-35 kcal/kg/day, 1.2-1.5g of protein/kg/day, and omega-3 to supplement any oral intake the patient might not have. If the intake is >80% of required intake, initiation of randomized therapy will only happen on the day the intake falls to <80% of required nutritional intake. Patients will be monitored until Day 15 where post-transplant evaluations will be conducted: blood work, BIA, SGA, ultrasound, BMI, food records, and medical evaluation. If at that time, patients are not consuming 50% of energy from oral feeds, nutrition therapy will continue until oral goal is met or until discharge for medical reasons. Patients will be assessed at Day+30 post-transplant in clinic and the following will be completed blood work, BIA, SGA, BMI, food records, ultrasound, medical complications and a QOL assessment. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Not Applicable | ||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Randomization will be 1:1, both EN and PN arms. The patients will be randomized in permutated blocks independently by Statistician. Masking: None (Open Label)Primary Purpose: Treatment |
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| Condition ICMJE | Malignant Hematologic Neoplasm | ||||||||
| Intervention ICMJE | Procedure: Parenteral Nutrition/Enteral Nutrition
Patients randomized to the parenteral nutrition arm will receive nutrition by IV and patients randomized to the enteral nutrition arm will receive nutrition by NG tube.
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| Study Arms ICMJE |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
40 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | December 31, 2020 | ||||||||
| Estimated Primary Completion Date | August 30, 2020 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 75 Years (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | Canada | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT04024618 | ||||||||
| Other Study ID Numbers ICMJE | LHSC BMT19.01 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Lawson Health Research Institute | ||||||||
| Study Sponsor ICMJE | Lawson Health Research Institute | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE | Not Provided | ||||||||
| PRS Account | Lawson Health Research Institute | ||||||||
| Verification Date | July 2019 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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