Early Nutritional Intervention to Prevent Malnutrition in Patients With Cancer Receiving Palliative Chemotherapy in an Outpatient Setting
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Nutritional Intervention
- Sponsor
- Gødstrup Hospital
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Body weight
- Status
- Recruiting
- Last Updated
- 4 months ago
Overview
Brief 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.
Investigators
Kirstine Guld Frederiksen
Principal investigator
Gødstrup Hospital
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
Outcomes
Primary Outcomes
Body weight
Time Frame: baseline, week 12 (±2 weeks), week 24 (±2 weeks)
Change in body weight in kilogram
Secondary Outcomes
- Hand grip strength(baseline, week 12 (±2 weeks), week 24 (±2 weeks))
- Muscle mass(baseline and week 24 (±2 weeks))
- Nutritional Risk(baseline, week 12 (±2 weeks), week 24 (±2 weeks))
- Survival(one year after initiation)
- Self reported Quality of life(baseline, week 12 (±2 weeks), week 24 (±2 weeks))
- Performance status(baseline, week 12 (±2 weeks), week 24 (±2 weeks))
- Duration of chemotherapy(week 24 (±2 weeks))
- Postponements in chemotherapy treatment(week 12 (±2 weeks), week 24 (±2 weeks))
- Timed up and go(baseline, week 12 (±2 weeks), week 24 (±2 weeks))
- Dose intensity(baseline, week 12 (±2 weeks), week 24 (±2 weeks))
- Chemotherapy(week 12 (±2 weeks), week 24 (±2 weeks))