To hear about similar clinical trials, please enter your email below
Trial Title:
Early Nutritional Intervention in Patients With Cancer
NCT ID:
NCT06141785
Condition:
Nutritional Intervention
Cancer
Malnutrition
Conditions: Official terms:
Malnutrition
Conditions: Keywords:
Nutritional interventions
Dietetics
Cancer
Malnutrition
Nutrition
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Intervention with a historical control cohort.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Nutritional intervention
Description:
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
Arm group label:
Nutritional Intervention
Summary:
The goal of this intervention study is to study the effect of nutritional interventions
in patients with cancer receiving palliative chemotherapy. The main question it aims to
answer is: Does early nutritional interventions affect body weight, quality of life,
survival, muscle mass, performance status, physical function, nutritional risk and
treatment tolerance in patients with cancer receiving palliative chemotherapy?
Researchers will compare patients receiving the intervention to a historical control
cohort following current clinical practice.
Detailed description:
Background 30-50% of patients with cancer are malnourished, resulting in poorer
prognosis, increased toxicities, reduced quality of life, and reduced physical function.
Nevertheless, cancer-related malnutrition remains largely unrecognized and undertreated
in clinical practice.
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- patients who are newly diagnosed with lung, colorectal, ovarian, or pancreatic
cancer.
- 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 not using electronic mail
- patients with dementia
- patients not able to comply with the study protocol
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Gødstrup Hospital
Address:
City:
Herning
Zip:
7400
Country:
Denmark
Contact:
Last name:
Kirstine Guld Frederiksen, MSc
Phone:
24248914
Phone ext:
0045
Email:
kirsfe@rm.dk
Investigator:
Last name:
Therese Ovesen, Prof
Email:
Principal Investigator
Start date:
February 2024
Completion date:
January 2027
Lead sponsor:
Agency:
Gødstrup Hospital
Agency class:
Other
Collaborator:
Agency:
Danish Cancer Society
Agency class:
Other
Source:
Gødstrup Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06141785
