Impact of Oral Nutritional Supplements on Patients Undergoing Hematopoietic Stem Cell Transplantation

Sponsor
RenJi Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05460013
Collaborator
(none)
100
2
17

Study Details

Study Description

Brief Summary

Malnutrition is common after hematopoietic 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 in 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 fibre upon 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-transplantation 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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Traditional Control
  • Dietary Supplement: Oral Nutritional Supplement
N/A

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 18-65 years with multiple myeloma 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. After recruitment, each participant will be allocated with a study specific code to protect their confidentiality. Anthropometry, biochemistry, and functional assessments are planned at four time points: after admission (baseline) and 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 hematology 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 1.2kg difference in body weight using an alpha=0.05(two-sided) to account for comparisons.

Plan for missing data:

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 noticed.

Statistical Analysis Plan:

The demographic and clinical characteristics of patients will be summarized using descriptive statistics. Data analysis will be carried out using SAS 9.4. Statistical analysis software. The mean or median change in continuous variables between the group by time points is assessed using t test or wilconxon's rank sum test. Changes in categorical variables is assessed using Pearson chi-square or McNemar's test. Analysis of covariance or Analysis of variance might be applied as needed.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Supportive Care
Official Title:
Impact of Oral Nutritional Supplements on Nutritional, Gut Functional and Clinical Outcomes: a Randomized Controlled Trial in Patients Undergoing Hematopoietic Stem Cell Transplantation
Anticipated Study Start Date :
Aug 1, 2022
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Placebo Control

Dietary Supplement: Traditional Control
Placebo control is a compounded made-up shake that is traditionally used by the Hematology ward to supplement patients receiving HSCT. The control provides an equivalent of 500kcals and 20.6g protein, 3.4g fiber per day. The participants will be asked to consume the control twice daily in whole admission.

Experimental: Oral Nutritional Intervention

Dietary Supplement: Oral Nutritional Supplement
The product to be studied is a standard polymeric formula. It is intended to provide 500cals, 18.4g protein, and 5g fiber per day. The fiber contained is mostly presented in the form of soluble fiber (inulin, fructo-oligosaccharide). The participants will be asked to consume the intervention twice a day throughout their admission.
Other Names:
  • Ensure Complete (Abbott)
  • Outcome Measures

    Primary Outcome Measures

    1. To examine the difference in body weight change between group [Change from baseline body weight to 28 days post transplantation]

      Body weight is assessed in kilograms

    Secondary Outcome Measures

    1. To examine the within group change for body weight [Change from baseline to the day of transplantation, 14 days post transplantation and 28 days post transplantation]

      Body weight is assessed in kilograms

    2. To examine the within group and between group change for fat free mass [Change from baseline to the day of transplantation, 14 days post transplantation and 28 days post transplantation]

      Fat free mass is assesses in kilograms

    3. To examine the within group and between group change for calf circumference [Change from baseline to the day of transplantation, 14 days post transplantation and 28 days post transplantation]

      Calf circumference is assessed in centimeter

    4. To examine the within group and between group change for handgrip test [Change from baseline to the day of transplantation, 14 days post transplantation and 28 days post transplantation]

      Handgrip test is assessed in kilograms

    5. To examine the within group and between group change for Patient-Generated Subjective Global Assessment [Change from baseline to the day of transplantation, 14 days post transplantation and 28 days post transplantation]

      Patient-Generated Subjective Global Assessment (PG-SGA) is an universally used nutritional assessment tool. It is assessed in percentage based on the rated scores.

    6. To examine the within group and between group change for gut symptoms [Change from baseline to the day of transplantation, 14 days post transplantation and 28 days post transplantation]

      Gut symptoms is assessed through the presence of diarrhoea and bloating in percentage

    7. To examine the between group difference for infection rate [at 28 days post transplantation]

      Infection rate is assessed in percentage

    8. To examine the tolerability of supplementing the standard polymeric formula in the targeted population [at 28 days post transplantation]

      This refers to the drop-out rate

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Diagnosed with multiple myeloma planned for HSCT

    • No contraindications to enteral nutrition

    • Able to consent

    Exclusion Criteria:
    • Existing contraindications to enteral nutrition

    • Existing infectious diarrhea

    • Had other malignancies

    • Had gut surgery in a year

    • Had used prebiotics or probiotics or synbiotics in a month

    • Immunosuppressive OR prolonged corticosteroid therapy (more than three months)

    • Chronic kidney disease (eGFR < 60 mL/min/1.73m2)

    • Pregnancy or lactation

    • Had an allergy, or intolerance to ingredients of dietary supplements

    • Judged to be unsafe to tolerate fiber

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • RenJi Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    RenJi Hospital
    ClinicalTrials.gov Identifier:
    NCT05460013
    Other Study ID Numbers:
    • 2021-M05
    First Posted:
    Jul 15, 2022
    Last Update Posted:
    Jul 15, 2022
    Last Verified:
    Jul 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by RenJi Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 15, 2022