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

NCT05460013 | Unknown

• 1 other identifier: 2021-M05
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Haematological Malignancy

Keywords

Hematopoietic Stem Cell Transplantation; Oral Nutritional Supplements; Body Weight; Body Composition

Outcome Measures

Primary Outcomes (1)

• The between-group change for body weight

  Body weight is assessed in kilograms

  Change from baseline in body weight at 28 days post transplantation

Secondary Outcomes (9)

• The within-group change for body weight

  Change from baseline in body weight at the day of transplantation, 14 days post transplantation and 28 days post transplantation

• The within-group and between-group change for fat free mass

  Change from baseline in fat free mass at the day of transplantation, 14 days post transplantation and 28 days post transplantation

• The within-group and between-group change for calf circumference

  Change from baseline in calf circumference at the day of transplantation, 14 days post transplantation and 28 days post transplantation

• The within-group and between-group change for handgrip test

  Change from baseline in handgrip test at the day of transplantation, 14 days post transplantation and 28 days post transplantation

• The within-group and between-group change for Patient-Generated Subjective Global Assessment

  Change from baseline in PG-SGA at 28 days post transplantation

Study Arms (2)

Placebo Control

PLACEBO COMPARATOR

Dietary Supplement: Traditional Control

Oral Nutritional Intervention

EXPERIMENTAL

Dietary Supplement: Oral Nutritional Supplement

Interventions

Traditional Control DIETARY_SUPPLEMENT

Placebo control is a compounded made-up shake that is traditionally used by the Haematology 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 randomly assigned to consume the control twice daily for the duration of 7 days prior to the admission to the day of discharge.

Placebo Control

Oral Nutritional Supplement DIETARY_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 randomly assigned to consume the intervention twice a day for the duration of 7 days prior to the admission to the day of discharge.

Also known as: Ensure Complete (Abbott)

Oral Nutritional Intervention

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Planned for HSCT
• No contraindications to enteral nutrition
• Able to consent

You may not qualify if:

• Existing contraindications to enteral nutrition
• Existing infectious diarrhoea
• Had other malignancies
• Had gut surgery in a year
• Had used prebiotics or probiotics or synbiotic 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

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200124, China

RECRUITING

MeSH Terms

Conditions

Hematologic Neoplasms; Body Weight

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Central Study Contacts

Renying Xu

CONTACT

+86-021-68383335; 721001735@shsmu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2022
• First Posted: July 15, 2022
• Study Start: August 1, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: August 1, 2023

Record last verified: 2023-07

Locations

CN (1)