Effect of an Oral Nutritional Supplement on Muscle Mass During Anticancer Treatment
NCT ID: NCT05648955
Last Updated: 2023-07-28
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
EARLY_PHASE1
118 participants
INTERVENTIONAL
2023-03-31
2025-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
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Test product
An enriched high protein and high energy oral nutrition supplement (ONS)
an enriched high protein and high energy oral nutrition supplement (ONS)
NA (see intervention name)
Control product
standard isocaloric high energy normal protein isocaloric ONS
an enriched high protein and high energy oral nutrition supplement (ONS)
NA (see intervention name)
Interventions
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an enriched high protein and high energy oral nutrition supplement (ONS)
NA (see intervention name)
Eligibility Criteria
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Inclusion Criteria
* Scheduled for the first cycle of any line of a systemic treatment: chemotherapy, concurrent chemoradiotherapy, immunotherapy or targeted treatment with a planned duration of at least 9 weeks
* Performance status Eastern Cooperative Oncology Group (ECOG) score 0 or 1
* Age ≥ 18 years
Exclusion Criteria
* Body Mass Index \> 30.0 kg/m2
* Life expectancy \< 3 months
* Receiving enteral (tube) or parenteral nutrition
* Presence of ileostoma or ileal pouch (except for an ileostomy at or near the terminal ileum which does not affect absorption of nutrients other than sodium, potassium, and water, in the opinion of the investigator)
* Allergy to cow's milk protein, soy or fish, requiring a fibre-free diet or suffering galactosemia or lactose intolerance
* Known pregnancy or lactation
* Current alcohol or drug abuse in the opinion of the investigator
* Wearing an electronic implant and/or pacemaker
* Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements
* Participation in any other studies involving investigational or marketed products concomitantly or within 14 days prior to entry into the study
18 Years
ALL
No
Sponsors
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Nutricia Research
INDUSTRY
Responsible Party
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Locations
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UCC
Cork, , Ireland
Countries
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Central Contacts
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Facility Contacts
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Study Coordinator
Role: primary
Other Identifiers
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MPR15ON89540
Identifier Type: -
Identifier Source: org_study_id
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