Early Nutritional Intervention in Patients With Cancer

NCT06141785 | Recruiting

• 1 other identifier: KGF-1-2023
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Nutritional Intervention; Cancer; Malnutrition

Keywords

Nutritional interventions; Dietetics; Cancer; Malnutrition; Nutrition

Outcome Measures

Primary Outcomes (1)

• Body weight

  Change in body weight in kilogram

  baseline, week 12 (±2 weeks), week 24 (±2 weeks)

Secondary Outcomes (11)

• Self reported Quality of life

  baseline, week 12 (±2 weeks), week 24 (±2 weeks)

• Survival

  one year after initiation

• Muscle mass

  baseline and week 24 (±2 weeks)

• Performance status

  baseline, week 12 (±2 weeks), week 24 (±2 weeks)

• Hand grip strength

  baseline, week 12 (±2 weeks), week 24 (±2 weeks)

Study Arms (2)

Nutritional Intervention

EXPERIMENTAL

Patients with Cancer treated with palliative chemotherapy.

Other: Nutritional intervention

Historical control

NO INTERVENTION

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.

Interventions

Nutritional intervention OTHER

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

Nutritional Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients not using electronic mail
• patients with dementia
• patients not able to comply with the study protocol

Sponsors & Collaborators

• Danish Cancer Society: collaborator
• Gødstrup Hospital: lead

Study Sites (1)

Gødstrup Hospital

Herning, 7400, Denmark

RECRUITING

MeSH Terms

Conditions

Neoplasms; Malnutrition

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Therese Ovesen, Prof

  University Clinic for Flavour, Balance and Sleep

  STUDY DIRECTOR

Central Study Contacts

Kirstine Guld Frederiksen, MSc

CONTACT

24248914; kirsfe@rm.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Intervention with a historical control cohort.

Study Record Dates

• First Submitted: November 7, 2023
• First Posted: November 21, 2023
• Study Start: June 1, 2024
• Primary Completion: March 31, 2026
• Study Completion (Estimated): January 29, 2027
• Last Updated: December 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)