Effects of oral nutritional supplements on patients undergoing stem cell transplantation
Impact of Oral Nutritional Supplements on Nutritional, Gut Functional and Clinical Outcomes: a Randomized Controlled Trial in Patients Undergoing Haematopoietic Stem Cell Transplantation
This study is testing whether oral nutritional supplements can help patients aged 18 to 75 who are about to have stem cell transplants stay nourished and healthy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | RenJi Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Shanghai, Shanghai) |
| Trial ID | NCT05460013 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of oral nutritional supplements (ONS) on patients who are scheduled to undergo haematopoietic stem cell transplantation (HSCT). It aims to address the common issue of malnutrition that occurs post-transplant due to various treatment-related side effects that hinder oral intake. Participants aged 18 to 75 will be randomly assigned to receive either ONS or a placebo for seven days prior to their HSCT. Assessments of body weight, serum albumin levels, and overall nutritional intake will be conducted at multiple time points to evaluate the effectiveness of the intervention.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 who are planned for HSCT and can provide informed consent.
Not a fit: Patients with contraindications to enteral nutrition or those with certain medical conditions such as chronic kidney disease or recent gut surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve nutritional status and overall recovery for patients undergoing HSCT.
How similar studies have performed: Limited retrospective studies have suggested potential benefits of nutritional supplementation in similar patient populations, but this approach is still being explored.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Planned for HSCT * No contraindications to enteral nutrition * Able to consent Exclusion Criteria: * 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
Where this trial is running
Shanghai, Shanghai
- Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine — Shanghai, Shanghai, China (Recruiting)
Study contacts
- Study coordinator: Renying Xu
- Email: 721001735@shsmu.edu
- Phone: +86-021-68383335
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.