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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 65 Years
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05460013
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

RenJi Hospital
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Not yet recruiting
Countries
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Myeloma Multiple
Additional Details

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.

Arms & Interventions

Arms

Placebo Comparator: Placebo Control

Experimental: Oral Nutritional Intervention

Interventions

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.

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.

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

For additional contact information, you can also visit the trial on clinicaltrials.gov.