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

Influence of Protein Intake on Muscle Mass and Health-related Quality of Life During and After Radiotherapy in Patients With Various Tumor Diseases

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.

Study Overview

• Status: Recruiting
• Conditions: Malnutrition; Cachexia

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.

• Study Type: Observational
• Enrollment (Estimated): 175

Contacts and Locations

• Study Contact: Name: Franziska Hausmann, MD; Phone Number: 030 450557088; Email: franziska.hausmann@charite.de

Study Locations

• Germany
  • State of Berlin
    • Berlin, State of Berlin, Germany, 13353
      • Recruiting
      • Charite University Medicine Berlin
      • Contact: Franziska Hausmann, MD; Phone Number: +4930450 557088; Email: franziska.hausmann@charite.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• 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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight in kg	Body Weight	baseline, end of radiotherapy and 3 months after Radiotherapy
Muscle mass in kg	Evaluation of Muscle mass via Bioimpedance Measurements	baseline, end of radiotherapy and 3 months after Radiotherapy
Quality of Life (EORTC QLQ C30) in 5-tier likert scale (higher scores = better)	Health Related Quality of Life with EORTC QLQ C30	baseline, end of radiotherapy and 3 months after Radiotherapy
Height in m	Height	baseline, end of radiotherapy and 3 months after Radiotherapy
Fatigue in 5-tier likert scale (higher scores = worse)	FACIT F Questionnaire	baseline, end of radiotherapy and 3 months after Radiotherapy
BMI in kg/m²	BMI calculated from weight and Hight	baseline, end of radiotherapy and 3 months after Radiotherapy
Treatment Toxicity via CTCA criteria (5 tier scale; higher = worse)	Common Terminology Criteria for Adverse Events (CTCAE) version 5	baseline, weekly during radiotherapy, end of treatment, follow up (up to 1 year, on average every 3 months)
Treatment Toxicity via PROMs (5 tier scale; higher = worse)	Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE®)	baseline, weekly during radiotherapy, end of treatment, follow up (up to 1 year, on average every 3 months)

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2024
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: February 6, 2024
• First Submitted That Met QC Criteria: June 24, 2024
• First Posted (Actual): June 28, 2024

Study Record Updates

• Last Update Posted (Estimated): September 4, 2025
• Last Update Submitted That Met QC Criteria: August 27, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Inflammation; Cancer; Microbiome; Nutrition; Radiotherapy; Sarcopenia
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neuromuscular Manifestations; Pathologic Processes; Nutrition Disorders; Pathological Conditions, Anatomical; Body Weight; Body Weight Changes; Muscular Atrophy; Atrophy; Weight Loss; Thinness; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Malnutrition; Neoplasms; Inflammation; Sarcopenia; Cachexia
• Other Study ID Numbers: EA1/101/23

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No