An observational study in Malnutrition; Cachexia, sponsored by Charite University, Berlin, Germany. Recruiting at 1 site in Germany. Open to participants aged 45 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-09-04.
Sponsored by Charite University, Berlin, Germany · Observational
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.
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.
1,277 studies on the registry are indexed under Malnutrition; 230 are open to participants now.
This study's planned enrollment of 175 is below the median of 206 across 393 observational studies indexed under Malnutrition.
Browse Malnutrition studies →Charite University, Berlin, Germany is the lead sponsor of 857 studies on the registry; 129 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Time frame: baseline, end of radiotherapy and 3 months after Radiotherapy
Weight in kg
Body Weight
Time frame: baseline, end of radiotherapy and 3 months after Radiotherapy
Muscle mass in kg
Evaluation of Muscle mass via Bioimpedance Measurements
Time frame: 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
Time frame: baseline, end of radiotherapy and 3 months after Radiotherapy
Height in m
Height
Time frame: baseline, end of radiotherapy and 3 months after Radiotherapy
Fatigue in 5-tier likert scale (higher scores = worse)
FACIT F Questionnaire
Time frame: baseline, end of radiotherapy and 3 months after Radiotherapy
BMI in kg/m²
BMI calculated from weight and Hight
Time frame: 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
Time frame: 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®)
Time frame: baseline, weekly during radiotherapy, end of treatment, follow up (up to 1 year, on average every 3 months)
Started Oct 2024 (actual). Primary completion is estimated for Oct 2026, 24 months after the start.
Of 174 non-industry observational studies under Malnutrition, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 41. This study's planned 24 months is close to that.
Counting every sponsor, half of 186 studies reached it within 21 months; a quarter within 11 and three quarters within 40.
How these figures are worked out, and which studies are left out of them.
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Charite University, Berlin, Germany →