Influence of Protein Intake on Muscle Mass and Health-related Quality of Life During and After Radiotherapy

NCT06480266 | Recruiting

• 1 other identifier: EA1/101/23
• Study Type: observational
• Target: 175
• Locations: 1 country
• Sites: 1

Brief Summary

The influence of radiotherapy on the protein intake and muscle mass of patients has not been extensively investigated to date. It is also unclear whether the localization of the tumor disease and thus the radiation field have different effects. Therefore, with the pilot study presented here, we would like to record the nutritional uptake of patients before and after radiotherapy. The aim is to determine the amount of energy and protein intake as well as the timing of protein intake. Furthermore, the relationship between the timing of protein intake and muscle mass will be investigated.

Conditions

Malnutrition; Cachexia

Keywords

Cancer; Radiotherapy; Nutrition; Sarcopenia; Inflammation; Microbiome

Outcome Measures

Primary Outcomes (1)

• Protein uptake in g/kg body weight

  Change in the amount of protein consumed and its distribution over the main meals by means of a dietary questionnaire before, at the end and 3 months after completion of radiotherapy.

  baseline, end of radiotherapy and 3 months after Radiotherapy

Secondary Outcomes (8)

• Weight in kg

  baseline, end of radiotherapy and 3 months after Radiotherapy

• Muscle mass in kg

  baseline, end of radiotherapy and 3 months after Radiotherapy

• Quality of Life (EORTC QLQ C30) in 5-tier likert scale (higher scores = better)

  baseline, end of radiotherapy and 3 months after Radiotherapy

• Height in m

  baseline, end of radiotherapy and 3 months after Radiotherapy

• Fatigue in 5-tier likert scale (higher scores = worse)

  baseline, end of radiotherapy and 3 months after Radiotherapy

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Indication for radio(chemo)therapy in the presence of one of the following histologically confirmed tumor diseases: Thorax, head and neck, breast, abdomen/pelvis, brain, bone metastases, prostate

You may qualify if:

• Capacity to consent
• At least 45 years of age
• Sufficient knowledge of the German language
• Indication to undergo radio(chemo)therapy with at least 10 fractions

You may not qualify if:

• Participation in other interventional studies
• Pregnancy/breastfeeding
• Previous intake of high-calorie supplementary food or intravenous nutrition
• BMI \< 18.5
• When performing the bioimpedance measurement: patients with pacemakers, defibrillators and other implanted automatic devices

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Charité University Medicine Berlin

Berlin, State of Berlin, 13353, Germany

RECRUITING

Biospecimen

Retention: NONE RETAINED

Stool

MeSH Terms

Conditions

Malnutrition; Cachexia; Neoplasms; Sarcopenia; Inflammation

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Weight Loss; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Thinness; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathologic Processes

Central Study Contacts

Franziska Hausmann, MD

CONTACT

030 450557088; franziska.hausmann@charite.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 6, 2024
• First Posted: June 28, 2024
• Study Start: October 16, 2024
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 4, 2025

Record last verified: 2025-08

Locations

DE (1)