Ignite Creation Date:
2024-05-06 @ 5:52 PM
Last Modification Date:
2024-10-26 @ 2:37 PM
Study NCT ID:
NCT05460013
Status:
RECRUITING
Last Update Posted:
2023-08-01
First Post:
2022-07-05
Brief Title:
Impact of Oral Nutritional Supplements on Patients Undergoing Haematopoietic Stem Cell Transplantation
Sponsor:
RenJi Hospital
Organization:
RenJi Hospital
Study Overview
Official Title:
Impact of Oral Nutritional Supplements on Nutritional Gut Functional and Clinical Outcomes a Randomized Controlled Trial in Patients Undergoing Haematopoietic Stem Cell Transplantation
Status:
RECRUITING
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Malnutrition is common after haematopoietic stem cell transplantation HSCT and is a well-known prognostic factor for survival HSCT-associated treatments are metabolic and digestively intolerant hence can induce a significant reduction in oral intake Thus weight loss as well as a reduction in serum albumin and pre-albumin levels are frequent following HSCT Although the gut remains functional sore mouth mucositis dysphagia nausea vomiting and diarrhoea will inevitably hinder the implementation of enteral nutrition EN thus leading to a deficit between daily intake and requirement Side effects of chemotherapy and antibiotics in combine will contribute to the alteration of intestinal flora on top of the existing gut symptoms further impairing nutrient digestion and absorption
Oral nutritional supplements ONS are foods for special medical purposes FSMP that are specially formulated for oral nutritional support Limited retrospective studies performed in Western countries have found that ONS was tolerable for HSCT patients eligible for EN however the data is sparse in China to support the safety of usage amongst this population On the other side what is less clear is the nature of soluble fiber upon the intestinal microenvironment in patients undergoing HSCT It would be worthwhile to investigate the impact of fibre-modulated ONS on gut function and symptoms
The study is a prospective study All the participants will be recruited from a single research center Renji Hospital The participants will be randomized into two groups traditional treatment or ONS Ensure complete Abbott which contains soluble dietary fiber such as fructo-oligosaccharide FOS and inulin will be served as the ONS for testing
The primary aim of the study is to examine the between-group change from baseline body weight at 28 days post-transplantation The secondary outcomes include the within-group and between-group dynamic change in the peri-transplant period for the following body weight fat-free mass circumference handgrip test and patient-generated global subjective assessment The tolerability of supplementing ONS and its effect on gut function as well as on infection rate is also of interest
Oral nutritional supplements ONS are foods for special medical purposes FSMP that are specially formulated for oral nutritional support Limited retrospective studies performed in Western countries have found that ONS was tolerable for HSCT patients eligible for EN however the data is sparse in China to support the safety of usage amongst this population On the other side what is less clear is the nature of soluble fiber upon the intestinal microenvironment in patients undergoing HSCT It would be worthwhile to investigate the impact of fibre-modulated ONS on gut function and symptoms
The study is a prospective study All the participants will be recruited from a single research center Renji Hospital The participants will be randomized into two groups traditional treatment or ONS Ensure complete Abbott which contains soluble dietary fiber such as fructo-oligosaccharide FOS and inulin will be served as the ONS for testing
The primary aim of the study is to examine the between-group change from baseline body weight at 28 days post-transplantation The secondary outcomes include the within-group and between-group dynamic change in the peri-transplant period for the following body weight fat-free mass circumference handgrip test and patient-generated global subjective assessment The tolerability of supplementing ONS and its effect on gut function as well as on infection rate is also of interest
Detailed Description:
Standard Operating Procedures
The study is located in Renji Hospital Stem Cell Transplant Unit including Haematology Outpatient Department and Clinical Nutrition Department All the patients aged between 18 and 75 years planned for HSCT and who are able to understand and sign an informed consent form are eligible for the study The potential participants will be provided with the information sheet by the dietitian on the day of their outpatient pre-assessment visit Each participant will be allocated with a study-specific code to protect their confidentiality After recruitment the participants will be asked to consume either the placebo control OR the ONS for testing intended for supplementation for the duration of 7 days prior to HSCT admission Anthropometry biochemistry and functional assessments are planned at four time points before admission baseline the day of transplantation D0 14 days post-transplantation D14 and 28 days post-transplantation D28 In addition nutritional intakes and gut assessments will be collected for the duration of the whole admission If a subject is discharged home before D14 or D28 then these will be attempted at the appropriate time when the patient attended Haematology Outpatients for medical follow-up visits Teleconsultation might be involved if the visit is not possible All the data will be stored in an electronic database It will be password protected with access only restricted to major investigators All adverse events occurring within the trial will be collected at each visit for assessment of safety
Sample Size Assessment
A total number of 100 participants is determined necessary to demonstrate an effect This sample size is designed to provide 85 power to detect a 12kg difference in body weight using an alpha005two-sided to account for comparisons
Plan for missing data
A variable could be reported as missing by reasons possibly associated with logistic issues or participants declined to take the measurements Strategy to minimize missing data includes setting up planning and time schedule in the Excel sheet to keep all the investigators notified
Statistical Analysis Plan
The demographic and clinical characteristics of patients will be summarized using descriptive statistics Data analysis will be carried out using Statistical Analysis System SAS 94 Statistical analysis software The mean or median change in continuous variables between the group by time points is assessed using t-test or Wilcoxons rank sum test Changes in categorical variables is assessed using Pearson chi-square or McNemars test Analysis of covariance or Analysis of variance might be applied as needed
The study is located in Renji Hospital Stem Cell Transplant Unit including Haematology Outpatient Department and Clinical Nutrition Department All the patients aged between 18 and 75 years planned for HSCT and who are able to understand and sign an informed consent form are eligible for the study The potential participants will be provided with the information sheet by the dietitian on the day of their outpatient pre-assessment visit Each participant will be allocated with a study-specific code to protect their confidentiality After recruitment the participants will be asked to consume either the placebo control OR the ONS for testing intended for supplementation for the duration of 7 days prior to HSCT admission Anthropometry biochemistry and functional assessments are planned at four time points before admission baseline the day of transplantation D0 14 days post-transplantation D14 and 28 days post-transplantation D28 In addition nutritional intakes and gut assessments will be collected for the duration of the whole admission If a subject is discharged home before D14 or D28 then these will be attempted at the appropriate time when the patient attended Haematology Outpatients for medical follow-up visits Teleconsultation might be involved if the visit is not possible All the data will be stored in an electronic database It will be password protected with access only restricted to major investigators All adverse events occurring within the trial will be collected at each visit for assessment of safety
Sample Size Assessment
A total number of 100 participants is determined necessary to demonstrate an effect This sample size is designed to provide 85 power to detect a 12kg difference in body weight using an alpha005two-sided to account for comparisons
Plan for missing data
A variable could be reported as missing by reasons possibly associated with logistic issues or participants declined to take the measurements Strategy to minimize missing data includes setting up planning and time schedule in the Excel sheet to keep all the investigators notified
Statistical Analysis Plan
The demographic and clinical characteristics of patients will be summarized using descriptive statistics Data analysis will be carried out using Statistical Analysis System SAS 94 Statistical analysis software The mean or median change in continuous variables between the group by time points is assessed using t-test or Wilcoxons rank sum test Changes in categorical variables is assessed using Pearson chi-square or McNemars test Analysis of covariance or Analysis of variance might be applied as needed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None