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NCT Number: NCT06480266

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

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.

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Key information

Conditions

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

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Charité University Medicine Berlin

Berlin, State of Berlin, 13353, Germany

Location status: Recruiting

Location contact

Franziska Hausmann, MD

CONTACT

[email protected]

+4930450 557088

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Protein uptake in g/kg body weight

    Time frame: baseline, end of radiotherapy and 3 months after Radiotherapy

    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.

Secondary outcomes

  1. Weight in kg

    Time frame: baseline, end of radiotherapy and 3 months after Radiotherapy

    Body Weight

  2. Muscle mass in kg

    Time frame: baseline, end of radiotherapy and 3 months after Radiotherapy

    Evaluation of Muscle mass via Bioimpedance Measurements

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

    Time frame: baseline, end of radiotherapy and 3 months after Radiotherapy

    Health Related Quality of Life with EORTC QLQ C30

  4. Height in m

    Time frame: baseline, end of radiotherapy and 3 months after Radiotherapy

    Height

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

    Time frame: baseline, end of radiotherapy and 3 months after Radiotherapy

    FACIT F Questionnaire

  6. BMI in kg/m²

    Time frame: baseline, end of radiotherapy and 3 months after Radiotherapy

    BMI calculated from weight and Hight

  7. Treatment Toxicity via CTCA criteria (5 tier scale; higher = worse)

    Time frame: baseline, weekly during radiotherapy, end of treatment, follow up (up to 1 year, on average every 3 months)

    Common Terminology Criteria for Adverse Events (CTCAE) version 5

  8. Treatment Toxicity via PROMs (5 tier scale; higher = worse)

    Time frame: baseline, weekly during radiotherapy, end of treatment, follow up (up to 1 year, on average every 3 months)

    Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE®)

Study contacts

Contact information is provided by the study sponsor or research team.

Franziska Hausmann, MD

CONTACT

[email protected]

030 450557088

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Official study title

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

Acronym: pROtein

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 28, 2024
Registry last updated
Sep 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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