Early Nutritional Intervention in Patients With Cancer (NICOS)

Gødstrup Hospital

Status: Enrolling

Conditions: Malnutrition; Nutritional Intervention; Cancer

Treatments: Other: Nutritional intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06141785

KGF-1-2023

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Nutritional Intervention

Experimental group

Description:

Patients with Cancer treated with palliative chemotherapy.

Treatment:

Other: Nutritional intervention

Historical control

No Intervention group

Description:

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.