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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RECRUITING
NA
200 participants
INTERVENTIONAL
2024-06-01
2027-01-29
Brief Summary
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Detailed Description
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Aim To examine the effect of an early individualised nutritional intervention on body weight, quality of life, survival, muscle mass, performance status, physical function, nutritional risk, and treatment tolerance in patients with cancer receiving palliative chemotherapy.
Methods An intervention study with a historical control cohort. Participants are newly diagnosed patients with lung, pancreatic, ovarian, or colorectal cancers recruited at initiation of palliative chemotherapy. The control group followed current clinical practice. The intervention group receives an individualised nutritional intervention delivered by a clinical dietitian from treatment initiation and throughout the treatment trajectory. The intervention is tailored to the participant's nutritional needs, food preferences, nutrition impact symptoms, and smell- and taste disorders. The primary endpoint is change in body weight. Secondary endpoints include quality of life, survival, muscle mass, performance status, physical function, nutritional risk, and treatment tolerance. Data are collected at baseline and after 12 and 24 weeks.
Perspectives The project will provide new knowledge on the effects of individualised nutritional interventions for patients with cancer receiving palliative chemotherapy, and the potential to improve quality of life, treatment tolerance, and survival.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Nutritional Intervention
Patients with Cancer treated with palliative chemotherapy.
Nutritional intervention
An individually targeted nutritional intervention, and a simple home-based physical exercise program. The Nutritional intervention will be delivered by a clinical dietitian, from treatment initiation and throughout the treatment trajectory
Historical control
Patients with Cancer treated with palliative chemotherapy.
Historical Control cohort following current clinical practise, where nutritional treatment is not systematically implemented but patients can be referred to a clinical dietitian after clinical assessment by the treating physician or nurse.
No interventions assigned to this group
Interventions
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Nutritional intervention
An individually targeted nutritional intervention, and a simple home-based physical exercise program. The Nutritional intervention will be delivered by a clinical dietitian, from treatment initiation and throughout the treatment trajectory
Eligibility Criteria
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Inclusion Criteria
* patients treated with first-line palliative chemotherapy
* patients who are Danish speaking
* patients ≥18 years of age
* patients who are cognitive well-functioning
Exclusion Criteria
* patients with dementia
* patients not able to comply with the study protocol
18 Years
ALL
No
Sponsors
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Danish Cancer Society
OTHER
Gødstrup Hospital
OTHER
Responsible Party
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Kirstine Guld Frederiksen
Principal investigator
Principal Investigators
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Therese Ovesen, Prof
Role: STUDY_DIRECTOR
University Clinic for Flavour, Balance and Sleep
Locations
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Gødstrup Hospital
Herning, , Denmark
Countries
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Central Contacts
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Facility Contacts
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Kirstine Guld Frederiksen, MSc
Role: primary
Other Identifiers
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KGF-1-2023
Identifier Type: -
Identifier Source: org_study_id