Malnutrition; CachexiapROteinNCT06480266
Influence of Protein Intake on Muscle Mass and Health-related Quality of Life During and After Radiotherapy
An observational study of Malnutrition; Cachexia, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Malnutrition; Cachexia
- How many people
- 175 participants
- Where
- 1 siteGermany
- Study dates
- 16 Oct 2024to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Charité University Medicine Berlin
Berlin, State of Berlin, 13353
Franziska Hausmann, MD, +4930450 557088, franziska.hausmann@charite.de
About this study
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
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.
Read the 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
- Keywords
- Cancer, Radiotherapy, Nutrition, Sarcopenia, Inflammation, Microbiome
- Medical subject headings
- Malnutrition, Cachexia, Neoplasms, Sarcopenia, Inflammation
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, end of radiotherapy and 3 months after Radiotherapy
Secondary outcomes (8)
Weight in kg
Body Weight
Measured: baseline, end of radiotherapy and 3 months after Radiotherapy
Muscle mass in kg
Evaluation of Muscle mass via Bioimpedance Measurements
Measured: 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
Measured: baseline, end of radiotherapy and 3 months after Radiotherapy
Height in m
Height
Measured: baseline, end of radiotherapy and 3 months after Radiotherapy
Fatigue in 5-tier likert scale (higher scores = worse)
FACIT F Questionnaire
Measured: baseline, end of radiotherapy and 3 months after Radiotherapy
BMI in kg/m²
BMI calculated from weight and Hight
Measured: 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
Measured: 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®)
Measured: baseline, weekly during radiotherapy, end of treatment, follow up (up to 1 year, on average every 3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2024
- Study start16 Oct 2024
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malnutrition; CachexiaStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 175 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Franziska Hausmann, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06480266
- Sponsor's protocol ID
- EA1/101/23
- Acronym
- pROtein
- Status last verified
- Aug 2025
- First submitted
- 6 Feb 2024
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06480266
- Acronym / sponsor ID
- pROtein / EA1/101/23
- Conditions
- Malnutrition; Cachexia
- Keywords
- Cancer, Radiotherapy, Nutrition, Sarcopenia, Inflammation, Microbiome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 175 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 16 Oct 2024 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 28 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
8 secondary outcomes
Weight in kg
Time frame: baseline, end of radiotherapy and 3 months after Radiotherapy
Muscle mass in kg
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)
Time frame: baseline, end of radiotherapy and 3 months after Radiotherapy
Height in m
Time frame: baseline, end of radiotherapy and 3 months after Radiotherapy
Fatigue in 5-tier likert scale (higher scores = worse)
Time frame: baseline, end of radiotherapy and 3 months after Radiotherapy
BMI in kg/m²
Time frame: baseline, end of radiotherapy and 3 months after Radiotherapy
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)
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malnutrition; Cachexia, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Franziska Hausmann, MD (030 450557088, franziska.hausmann@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Protein uptake in g/kg body weight (time frame: baseline, end of radiotherapy and 3 months after Radiotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2025.