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

NCT ID: NCT06480266

Last Updated: 2025-09-04

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 175 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-10-16
• Study Completion Date: 2026-12-31

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.

Detailed Description

Many studies have shown that cancer patients have a very high prevalence of malnutrition. Several large-scale studies have reported that 50-80% of these patients are affected by involuntary weight loss, with the extent of weight loss depending on the tumor location and the type and stage of the disease. It has been widely reported that nutritional interventions are essential in cancer patients. Nevertheless, nutritional support is still not universally accessible to all patients. Given the prevalence of nutritional risks, the treatment of lean muscle mass loss remains a challenge in clinical practice. For this reason, a multidisciplinary approach with targeted nutritional therapy is crucial to improve the quality of care in oncology. A protein level of 1-1.2 g/kg bw is suggested for the maintenance of muscle mass.However, it has been shown that this amount is not sufficient to support ALM in patients with tumor diseases. Only an amount above 1.4 g/kg bw has been associated with a positive effect on muscle mass. Adequate dietary protein intake is essential for the maintenance of numerous physiological processes, including muscle protein synthesis and muscle function. Sufficient energy and protein intake is necessary to support muscle protein synthesis. The scientific literature frequently discusses the relationship between daily protein intake and its distribution over the main meals. The evening meal is particularly important for the maintenance of ALM.

Conditions

Malnutrition; Cachexia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Charite University, Berlin, Germany

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dr. Franziska Hausmann

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Charité University Medicine Berlin

Berlin, State of Berlin, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Franziska Hausmann, MD

Role: CONTACT

franziska.hausmann@charite.de

030 450557088

Facility Contacts

Franziska Hausmann, MD

Role: primary

franziska.hausmann@charite.de

+4930450 557088

Other Identifiers

EA1/101/23

Identifier Type: -

Identifier Source: org_study_id