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| ID | Type | Description | Link |
|---|---|---|---|
| ACTRN12615001329550 | Registry Identifier | Australian New Zealand Clinical Trials Registery | |
| U1111-1194-5952 | Other Identifier | WHO Universal Trial Number |
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| Name | Class |
|---|---|
| Australasian Bone Marrow Transplant Recipient Registry | UNKNOWN |
| University of Roma La Sapienza | OTHER |
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Supplemental prophylactic early parenteral nutrition will be commenced 1 day prior to conditioning chemoradiotherapy in patients who are not already malnourished. Supplemental parenteral nutrition continues throughout conditioning chemoradiotherapy and stem cell transplant.
A standard parenteral nutrition solution will be used. The parenteral nutrition solution will be given once daily, and infused intravenously. The standard parenteral nutrition solution will contain approximately 40 grams of amino acids/L, 40 g lipids/L and 100g dextrose/L). Nutritional targets will be measured using indirect Calorimetry where available, or calculated via the Harris Benedict or Schofield equations. The dose of parenteral nutrition administered will be determined by the treating dietitian, treating physician or treating research team. The parenteral nutrition dose given will be individualised considering the patients clinical condition and body weight. The dose of supplemental parenteral nutrition will be dependent on the total calories also received from oral and/or enteral nutrition intake.
Supplemental parenteral nutrition will be discontinued when a patient is well enough to be discharged from hospital or when the patients attending clinician determines a central line is no longer needed for standard care. There is no maximum duration of supplemental parenteral nutrition..
Adherence to the study intervention will be monitored via medical chart reviews during site monitoring visits, and data queries on individual patient case report form documentation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Care | Active Comparator | The control group in this study is pragmatic standard nutrition care. Currently after a bone marrow transplant in Australia, patients are normally fed orally for as long as possible. If oral intake fails to provide sufficient calories for a period of two to three days, enteral or parenteral nutrition may be provided. |
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| Early supplemental parenteral nutrition | Active Comparator | Supplemental prophylactic early parenteral nutrition will be commenced 1 day prior to conditioning chemoradiotherapy in patients who are not already malnourished. Supplemental parenteral nutrition continues throughout conditioning chemoradiotherapy and stem cell transplant. The dose of supplemental parenteral nutrition will be dependent on the total calories also received from oral and/or enteral nutrition intake. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Parenteral nutrition. | Dietary Supplement | Nutrition support will be provides as per usual, but oral and enteral intake will be topped up with a standard parenteral nutrition solution. The standard parenteral nutrition solution will contain approximately 40 grams of amino acids/L, 40 g lipids/L and 100g dextrose/L). |
| Measure | Description | Time Frame |
|---|---|---|
| Disease free survival time | Defined as time to relapse or death whichever occurs first | Recruitment will run for 3 years, with a median follow-up time of 2 years. |
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Inclusion Criteria:
Exclusion Criteria:
Participants will be assigned a biological sex based on their legal gender established at time of enrolment.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gordon S Doig, PhD | Contact | +61294632600 | gdoig@med.usyd.edu.au | |
| Fiona Simpson, PhD | Contact | +61294632600 | fsimpson@med.usyd.edu.au |
| Name | Affiliation | Role |
|---|---|---|
| Gordon S Doig, PhD | University of Sydney | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal North Shore Hospital | Recruiting | Sydney | New South Wales | Australia |
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| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D010288 | Parenteral Nutrition |
| ID | Term |
|---|---|
| D005248 | Feeding Methods |
| D013812 | Therapeutics |
| D018529 | Nutritional Support |
| D044623 | Nutrition Therapy |
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Assessment of bone marrow biopsy to determine transplant success will be undertaken independent of the knowledge of treatment assignment.
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| Pragmatic standard care. | Other | Nutrition support will be provided as per usual care. |
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| Royal Adelaide Hospital | Recruiting | Adelaide | South Australia | Australia |
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| Christchurch Hospital, CDHB | Recruiting | Christchurch | New Zealand |
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