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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01181076 |
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Date of registration:
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04/08/2010 |
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Primary sponsor: |
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Public title:
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Individualized Nutrition for Adult Recipients of Allogeneic Stem Cell Transplants - Effect on Quality of Life
NASQ |
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Scientific title:
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Individualized Nutrition for Adult Recipients of Allogeneic Stem Cell Transplants - Effect on Quality of Life |
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Date of first enrolment:
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August 2010 |
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Target sample size:
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100 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01181076 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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Countries of recruitment
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Norway
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Russian Federation
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Contacts
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Name:
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Kristin J Skaarud, MS |
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Address:
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Telephone:
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+4797699148 |
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Email:
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kristin.joan.skaarud@oslo-universitetssykehus.no |
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Affiliation:
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Name:
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Kristin J Skaarud, MS |
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Address:
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Telephone:
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Email:
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Affiliation:
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Oslo University Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- acute lymphatic leukaemia, acute myeloid leukaemia, chronic myeloproliferative
disease and chronic myelogenous leukaemia and other disorders accepted for allogeneic
stem cell transplantation, following myeloablative conditioning
Exclusion Criteria:
- unable to give informed consent
- unable to adhere to protocol due to reasons unrelated to the hematological condition
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Effect of Individualized Nutrition on Quality of Life
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Intervention(s)
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Dietary Supplement: Individualized Nutrition
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Primary Outcome(s)
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Global quality of life score
[Time Frame: 3 month after transplantation]
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Number of days with oral mucositis grade 3-4
[Time Frame: Up to 3 months]
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Secondary Outcome(s)
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Duration between stem cell transplantation and day of engraftment.
[Time Frame: Up to 1 months]
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Frequency of acute graft versus host disease grade 3-4
[Time Frame: Up to 3 months]
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Length of hospital stay
[Time Frame: Up to 8 months]
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Number of episodes with fever
[Time Frame: Up to 8 months]
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Nutrition status
[Time Frame: 3 month after transplantation]
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Quality of life scores for physical and social functions, fatigue, loss of appetite, nausea/vomiting and diarrhoea
[Time Frame: 3 months after transplantation]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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