Chemotherapy-related Toxicity, Nutritional Status and Quality of Life
NCT ID: NCT02848807
Last Updated: 2016-07-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2014-09-30
2016-12-31
Brief Summary
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Detailed Description
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* to determine whether high protein ONS influence on the nutritional status
* to determine whether high protein ONS influence on the quality of life
* to determine whether high protein ONS influence on the performance status
* to determine high protein ONS tolerability / ONS intake compliance
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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NUTRIDRINK Compact Protein
NUTRIDRINK Compact Protein Oral nutritional supplement Dietary advice
NUTRIDRINK Compact Protein
high-energy, high-protein, oral liquid nutritional supplement; dosage: 2x125 ml per day, 7 days per week for 12 weeks (3 months)
without oral nutritional supplements
Dietary advice alone
No interventions assigned to this group
Interventions
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NUTRIDRINK Compact Protein
high-energy, high-protein, oral liquid nutritional supplement; dosage: 2x125 ml per day, 7 days per week for 12 weeks (3 months)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* successful qualification to chemotherapy
* performance status at least 80% according to Karnofsky scale and \<2 according to WHO/ECOG scale
* cancer-related asymptomatic precachexia diagnosed
* absence of contraindications to oral nutrition and practicable realization of oral nutrition
* absence of severe, decompensated concomitant diseases
* signed informed consent for the participation in the study
Exclusion Criteria
* disqualification from oncologic treatment
* cancer cachexia or cancer anorexia-cachexia syndrome
* poor performance status
* contraindications to oral nutrition or to high protein nutrition
* regular nutritional support at the moment of qualification to the study
* patient incompliance at the moment of qualification to the study
18 Years
ALL
No
Sponsors
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Nutricia Foundation
OTHER
University Clinical Centre, Gdansk
OTHER
Responsible Party
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Principal Investigators
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Sylwia Malgorzewicz, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Clinical Centre, Gdansk, Poland
Locations
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University Clinical Centre
Gdansk, , Poland
Countries
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Central Contacts
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Facility Contacts
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Sylwia Malgorzewicz, MD, PhD
Role: primary
Other Identifiers
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01/2014/UCK
Identifier Type: -
Identifier Source: org_study_id