Clinical trial · Interventional
Feasibility Study Comparing Enteral vs Parenteral Nutritional Outcomes in Autologous Stem Cell Transplant Patients
A Pilot Feasibility Study of Nutritional Outcomes in Autologous Hematopoietic Stem Cell Transplant Recipients Comparing Enteral Nutrition Versus Parenteral Nutrition
NCT04024618CI-TRIAL-00044360unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study will highlight that Enteral Nutrition (EN) is as effective in nutritionally supporting as Parenteral Nutrition (PN) in this group of patients undergoing an autologous hematopoietic stem cell transplantation (AHSCT). The rationale of this study is to compare nutritional, medical, cost and Quality of Life (QOL) outcomes in patients receiving either EN or PN nutritional support in patients. The main outcomes are to examine are nutritional status, medical complications, cost and QOL before and after AHSCT.
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 Hematologic Neoplasm | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Parenteral Nutrition/Enteral Nutrition | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Parenteral Nutrition
- description
- Patients who have been randomized to receive PN will be started on day 5 post AHSCT. This will be if patient intake is \< 80% of usual oral intake at that time. The central venous catheter required for PN administration will be already in place for AHSCT treatment, prior to admission and pre-transplant evaluation. Nutritional support will continue until oral intake is \>50% or until the patient is ready for discharge if intake remains \< 50% of recommendations.
- interventionNames
- Procedure: Parenteral Nutrition/Enteral Nutrition
- type
- EXPERIMENTAL
- label
- Enteral Nutrition
- description
- Patients who have been randomized to receive EN will have a Nasogastric tube (NGT) inserted on day 5 post AHSCT, prior to start of Enteral feeds. This would be a polyurethane tube, 8-10 French, which will be inserted by physician or Nurse Practitioner with position confirmed by radiological examination. This will be if patient intake is \< 80% of usual oral intake at that time. Nutritional support will continue until oral intake is \>50% or until the patient is ready for discharge if intake remains \< 50% of recommendations.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * All adult patients aged 18 to 75 years. * Patients admitted to Victoria Hospital undergoing AHSCT on C7 unit. * Patient consented to participate in the study * Patients diagnosed with the following conditions: Non- Hodgkin's Lymphoma (all types), Hodgkin's Lymphoma (all subtypes) and Multiple Myeloma * Patients receiving any of the following: Conditioning chemotherapy: Melphalan, Etoposide/Melphalan, or Carmustine, Etoposide, Cytarabine, Melphalan * Have a functional Gastrointestinal tract Exclusion Criteria: * Intestinal obstruction * Patients with nasal deformities, tumors of nasal tracts or upper nare obstruction. * Patients with active bacteremia while proceeding with transplant * Patients with active malignancy of Upper GI tract, not in remission as evidenced by recent imaging studies (\< 4 weeks) * Patients with any GI bleeding, paralytic ileus, obstruction, or any other GI condition which excludes use of the GI system for nutritional support as these patients will require PN feeding only and cannot be randomized
References
Publications (16)
- BACKGROUNDSekine L, Ziegelmann PK, Manica D, da Fonte Pithan C, Sosnoski M, Morais VD, Falcetta FS, Ribeiro MR, Salazar AP, Ribeiro RA. Frontline treatment for transplant-eligible multiple myeloma: A 6474 patients network meta-analysis. Hematol Oncol. 2019 Feb;37(1):62-74. doi: 10.1002/hon.2552. Epub 2018 Sep 20. PMID 30129104
- BACKGROUNDGisselbrecht C, Van Den Neste E. How I manage patients with relapsed/refractory diffuse large B cell lymphoma. Br J Haematol. 2018 Sep;182(5):633-643. doi: 10.1111/bjh.15412. Epub 2018 May 29. PMID 29808921
- BACKGROUNDLipkin AC, Lenssen P, Dickson BJ. Nutrition issues in hematopoietic stem cell transplantation: state of the art. Nutr Clin Pract. 2005 Aug;20(4):423-39. doi: 10.1177/0115426505020004423. PMID 16207682
- BACKGROUNDBuono R, Longo VD. Starvation, Stress Resistance, and Cancer. Trends Endocrinol Metab. 2018 Apr;29(4):271-280. doi: 10.1016/j.tem.2018.01.008. Epub 2018 Feb 17. PMID 29463451
- BACKGROUNDDeeg HJ, Seidel K, Bruemmer B, Pepe MS, Appelbaum FR. Impact of patient weight on non-relapse mortality after marrow transplantation. Bone Marrow Transplant. 1995 Mar;15(3):461-8. PMID 7599573
- BACKGROUNDAugust DA, Huhmann MB; American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.) Board of Directors. A.S.P.E.N. clinical guidelines: nutrition support therapy during adult anticancer treatment and in hematopoietic cell transplantation. JPEN J Parenter Enteral Nutr. 2009 Sep-Oct;33(5):472-500. doi: 10.1177/0148607109341804. No abstract available. PMID 19713551
- BACKGROUNDRoberts S, Miller J, Pineiro L, Jennings L. Total parenteral nutrition vs oral diet in autologous hematopoietic cell transplant recipients. Bone Marrow Transplant. 2003 Oct;32(7):715-21. doi: 10.1038/sj.bmt.1704204.