Clinical trial · Interventional
Early Oral Supplementation in Improving Nutritional Status in Patients Undergoing Hematopoietic Stem Cell Transplant
The Effect of Oral Supplementation and Improved Nutritional Status on Hematopoietic Stem Cell Transplant Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow Accrual
Summary
Brief summary (as posted)
This clinical trial studies the use of early oral supplementation in improving nutritional status in participants undergoing hematopoietic stem cell transplant. Impaired nutritional status in participants undergoing hematopoietic stem cell transplant has been linked to decreased outcomes such as increased length of hospital stay and increased time to engraftment (an important milestone in transplant recovery). Early oral supplementation may increase nutritional status and help to promote a positive outcome in participants undergoing transplant.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Neoplasm | Malignant Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Boost Plus | Dietary Supplement | — | UNRESOLVED |
| daily food diaries | Other | — | UNRESOLVED |
| Milkshake | Dietary Supplement | — | UNRESOLVED |
| Pro-Stat 101 | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Supportive care (Boost Plus, Pro-Stat 101)
- description
- Participants receive Boost Plus PO BID or Pro-Stat 101 PO BID beginning one week before scheduled HSCT and continuing until hospital discharge. If participants do not tolerate the Boost Plus or Pro-Stat, they receive a milkshake PO QD as an alternative.
- interventionNames
- Dietary Supplement: Boost Plus
- Dietary Supplement: Pro-Stat 101
- Dietary Supplement: Milkshake
- Other: daily food diaries
Primary outcomes (1)
- measure
- Change in nutritional status determined by the Patient-Generated Subjective Global Assessment (PG-SGA)
- timeFrame
- Baseline to time of hospital discharge, up to 1 year
- description
- To test the improvement of nutritional status over a period of time, a linear mixed model will be fit and the PG-SGA trend will be tested.
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Undergoing an autologous or reduced intensity conditioning (RIC) allogeneic HSCT * A serum albumin greater than or equal to 2.5 g/dL * Able to understand and sign consent Exclusion Criteria: * Patients who have malabsorption problems, such as ulcerative colitis, irritable bowel syndrome, Crohn's disease, bowel surgery such as gastric bypass, and celiac disease
References
Publications (0)
Data not yet available