Clinical trial NCT06141785: Early Nutritional Intervention in Patients With Cancer
Official title: Early Nutritional Intervention to Prevent Malnutrition in Patients With Cancer Receiving Palliative Chemotherapy in an Outpatient Setting
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Nutritional Intervention
Cancer
Malnutrition
Keywords: Nutritional interventions
Dietetics
Cancer
Malnutrition
Nutrition
Lead sponsor: Gødstrup Hospital
Sponsor class: OTHER
Collaborators: name: Danish Cancer Society
First posted: 2023-11-21
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention with a historical control cohort.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Body weight
timeFrame: baseline, week 12 (±2 weeks), week 24 (±2 weeks)
Secondary outcomes:
measure: Self reported Quality of life
timeFrame: baseline, week 12 (±2 weeks), week 24 (±2 weeks)
measure: Survival
timeFrame: one year after initiation
measure: Muscle mass
timeFrame: baseline and week 24 (±2 weeks)
measure: Performance status
timeFrame: baseline, week 12 (±2 weeks), week 24 (±2 weeks)
measure: Hand grip strength
timeFrame: baseline, week 12 (±2 weeks), week 24 (±2 weeks)
measure: Timed up and go
timeFrame: baseline, week 12 (±2 weeks), week 24 (±2 weeks)
measure: Nutritional Risk
timeFrame: baseline, week 12 (±2 weeks), week 24 (±2 weeks)
measure: Dose intensity
timeFrame: baseline, week 12 (±2 weeks), week 24 (±2 weeks)
measure: Chemotherapy
timeFrame: week 12 (±2 weeks), week 24 (±2 weeks)
measure: Duration of chemotherapy
timeFrame: week 24 (±2 weeks)
measure: Postponements in chemotherapy treatment
timeFrame: week 12 (±2 weeks), week 24 (±2 weeks)
Other outcomes:
Locations:
city: Herning
country: Denmark
facility: Gødstrup Hospital
Study officials:
affiliation: University Clinic for Flavour, Balance and Sleep
name: Therese Ovesen, Prof
role: STUDY_DIRECTOR
References: