Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06141785

Early Nutritional Intervention to Prevent Malnutrition in Patients With Cancer Receiving Palliative Chemotherapy in an Outpatient Setting

Led by Gødstrup Hospital · Updated on 2025-12-24

200

Participants Needed

1

Research Sites

43 weeks

Total Duration

On this page

Sponsors

G

Gødstrup Hospital

Lead Sponsor

D

Danish Cancer Society

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to study the effects of early nutritional interventions on patients with cancer who are receiving palliative chemotherapy. It focuses on whether these interventions impact body weight, quality of life, survival, muscle mass, physical function, nutritional risk, and treatment tolerance. The study compares patients receiving the nutritional intervention to a historical control group following current clinical practice. Participants newly diagnosed with lung, pancreatic, ovarian, or colorectal cancer start first-line palliative chemotherapy and receive an individualized nutritional intervention from a clinical dietitian. This intervention is tailored to each patient's nutritional needs, food preferences, and symptoms affecting taste and smell. The study also includes a simple home-based physical exercise program. The intervention is delivered from the start of treatment and continues throughout the chemotherapy period. The control group receives standard care without systematic nutritional treatment but may be referred to a dietitian after clinical assessment. Participants are assessed at baseline, 12 weeks, and 24 weeks for body weight, quality of life, muscle mass, performance status, hand grip strength, timed up and go test, nutritional risk, chemotherapy dose intensity, treatment postponements, and survival up to one year. Data collection includes self-reported questionnaires and clinical measurements to monitor treatment tolerance and physical function. The study aims to provide insights into how early nutritional support may improve the overall experience and outcomes for cancer patients undergoing palliative chemotherapy.

CONDITIONS

Brief Title

Early Nutritional Intervention in Patients With Cancer

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 or older
  • Patients who are cognitively well-functioning
Not Eligible

You will not qualify if you...

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

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 24 weeks

Participants receive an individualized nutritional intervention delivered by a clinical dietitian from the start and throughout palliative chemotherapy treatment.

Visits aligned with baseline, week 12, and week 24 assessments

Follow-up

Duration - Up to 1 year after treatment initiation

Participants are monitored for survival and treatment outcomes up to one year after starting the treatment.

Follow-up contacts may vary; specific visit schedule not defined

Trial Site Locations

Total: 1 location

1

Gødstrup Hospital

Herning, Denmark, 7400

Actively Recruiting

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Research Team

K

Kirstine Guld Frederiksen, MSc

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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