Clinical trial NCT06480266: Influence of Protein Intake on Muscle Mass and Health-related Quality of Life During and After Radiotherapy
Official title: Influence of Protein Intake on Muscle Mass and Health-related Quality of Life During and After Radiotherapy in Patients With Various Tumor Diseases
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Malnutrition; Cachexia
Keywords: Cancer
Radiotherapy
Nutrition
Sarcopenia
Inflammation
Microbiome
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2024-06-28
Enrollment: 175
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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

Primary outcomes:
measure: Protein uptake in g/kg body weight
timeFrame: baseline, end of radiotherapy and 3 months after Radiotherapy
Secondary outcomes:
measure: Weight in kg
timeFrame: baseline, end of radiotherapy and 3 months after Radiotherapy
measure: Muscle mass in kg
timeFrame: baseline, end of radiotherapy and 3 months after Radiotherapy
measure: Quality of Life (EORTC QLQ C30) in 5-tier likert scale (higher scores = better)
timeFrame: baseline, end of radiotherapy and 3 months after Radiotherapy
measure: Height in m
timeFrame: baseline, end of radiotherapy and 3 months after Radiotherapy
measure: Fatigue in 5-tier likert scale (higher scores = worse)
timeFrame: baseline, end of radiotherapy and 3 months after Radiotherapy
measure: BMI in kg/m²
timeFrame: baseline, end of radiotherapy and 3 months after Radiotherapy
measure: Treatment Toxicity via CTCA criteria (5 tier scale; higher = worse)
timeFrame: baseline, weekly during radiotherapy, end of treatment, follow up (up to 1 year, on average every 3 months)
measure: Treatment Toxicity via PROMs (5 tier scale; higher = worse)
timeFrame: baseline, weekly during radiotherapy, end of treatment, follow up (up to 1 year, on average every 3 months)
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité University Medicine Berlin
Study officials:
References: