Head and Neck CancersPRE-KOVERINCT06638216
Prospective Evaluation of Frailty in Patients With Head and Neck Tumors Before Curative Intended Therapy
A study testing Geriatric Assessment in people with Head and Neck Cancers, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
In a prospective study the fragility of patients with head and neck tumors before the start of curative therapy will be assessed. Primary objective: Fragility is assessed using the G8 questionnaire. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancers
- What is being tested?
- Geriatric Assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteGermany
- Study dates
- 7 Oct 2024to 12 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Indication for curative therapy in the case of an initial diagnosis of head and neck tumor disease
- Capacity to consent
- At least 18 years of age
- Sufficient knowledge of the German language
Who cannot join
- - Lack of capacity to consent
- Age <18 years
- Severe impairment of walking ability that makes it impossible to perform the 6MWT safely
- Contraindications for performing a 6MWT:
- Absolute contraindications for the procedure are
- unstable angina pectoris
Show all 11Show fewer
- myocardial infarction in the past month.
- Relative contraindications are
- a resting heart rate > 120/min
- systolic blood pressure > 180 mmHg
- a diastolic blood pressure > 100 mmHg.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Charité University Medicine Berlin
Berlin, State of Berlin, 13353
About this study
In a prospective study the fragility of patients with head and neck tumors before the start of curative therapy will be assessed.
Primary objective: Fragility is assessed using the G8 questionnaire.
Secondary objectives include the assessment of quality of life and financial burden (EORTC-QLQ C30+ H\&N43), swallowing function, cardiopulmonary resilience (6-minute walk test) and the patient's wishes regarding a prehabilitation program. Epidemiological and disease-related data is also collected.
Read the detailed description
In this prospective study patients with a tumor of the head and neck region, that are planned for Surgery or radiotherapy (chemotherapy) will be included. The probability of developing therapy-associated side effects is significantly increased if the patient is already in a limited general condition, also known as fragility, before the therapy. In addition, due to demographic change, the incidence of head and neck tumors will continue to increase, especially in patients of advanced age. Due to their age, other pre-existing conditions and infirmity, they are at a further increased risk of therapy-related side effects In order to improve the care of patients with head and neck tumors, we must first determine how many patients are affected by fragility. In addition, we want to determine influencing factors that are associated with fragility. These include, for example, difficulty swallowing and weight loss. Based on this data, we will then plan the implementation of an intervention study to establish a prehabilitation program.
- Conditions
- Head and Neck Cancers
- Being tested
- Geriatric Assessment
- Keywords
- Head and Neck Cancer, Frailty, Geriatric Assessment, Radiation, Maxillo-facial Surgery
- Medical subject headings
- Head and Neck Neoplasms, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Geriatric AssessmentOther
Frailty is assessed using the G8 questionnaire.
Secondary objectives include the assessment of quality of life and financial burden (EORTC-QLQ C30+ H\&N43), swallowing function, cardiopulmonary resilience (6-minute walk test) and the patient's wishes regarding a prehabilitation program. Epidemiological and disease-related data is also collected.
| Study group | Role | What they receive |
|---|---|---|
| Geriatric Assessment | Experimental | Frailty is assessed using the G8 questionnaire.
Secondary objectives include the assessment of quality of life and financial burden (EORTC-QLQ C30+ H\&N43), swallowing function, cardiopulmonary resilience (6-minute walk test) and the patient's wishes regarding a prehabilitation program. Epidemiological and disease-related data is also collected. Receives: Other: Geriatric Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frailty
Assessment via G8 (Geriatric Screening Tool) questionnaire consists of 8 questions. The score ranges from 0 (poor score) to 17 points (good score), and a score of 11 or lower indicated frailty, whereas a score between 12 and 14 equals pre-frail patients. Patients with a score above 14 are considert non-frail.
Measured: once prior to surgery or at beginning of radiation
Secondary outcomes (6)
EORTC-QLQ C30 questionnaire
EORTC-QLQ C30 questionnaire consist of 30 questions with a score range from 0 to 100. Higher scores represents better quality of life, low scores indicating lower quality of life.
Measured: prior to surgery or at beginning of radiotherapy
swallowing function
Questionnaire (M.D. Anderson Dysphagia Inventory), scores range from 20 (poor function) to 100 (high function)
Measured: prior to surgery or beginning of radiation
Cardio-pulmonary resilience
6-Minute Walk test
Measured: prior to surgery or beginning of radiation
Epidemiologic Data
Descriptive (e.g. income, alcohol use, smoking status), epidemiologic data is not scored
Measured: prior to surgery or beginning of radiation
Information on current tumor disease
number of patients with T1/T2/T3/T4 Tumor Stage and N1/N2/N3 lymphonodal stage
Measured: prior to surgery or beginning of radiation
EORTC-H&N43 questionnaire
EORTC-H\&N43 questionnaires. Scores are from 0 to 100. A high score indicates high level of symptamotology.
Measured: prior to surgery or at beginning of radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start7 Oct 2024
- Primary completion12 Jun 2025
- Study completion12 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancersStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 99 participants (actual)
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
- NCT06638216
- Sponsor's protocol ID
- EA1/168/24
- Acronym
- PRE-KOVERI
- Status last verified
- Aug 2025
- First submitted
- 6 Oct 2024
- Last updated
- 28 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Frailty in Patients With Head and Neck Tumors Before Curative Intended Therapy
- ClinicalTrials.gov ID
- NCT06638216
- Acronym / sponsor ID
- PRE-KOVERI / EA1/168/24
- Conditions
- Head and Neck Cancers
- Keywords
- Head and Neck Cancer, Frailty, Geriatric Assessment, Radiation, Maxillo-facial Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 7 Oct 2024 (actual)
- Primary completion
- 12 Jun 2025 (actual)
- Study completion
- 12 Jun 2025 (actual)
- First posted
- 15 Oct 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.
In a prospective study the fragility of patients with head and neck tumors before the start of curative therapy will be assessed.
Primary objective: Fragility is assessed using the G8 questionnaire.
Secondary objectives include the assessment of quality of life and financial burden (EORTC-QLQ C30+ H\&N43), swallowing function, cardiopulmonary resilience (6-minute walk test) and the patient's wishes regarding a prehabilitation program. Epidemiological and disease-related data is also collected.
Detailed description
In this prospective study patients with a tumor of the head and neck region, that are planned for Surgery or radiotherapy (chemotherapy) will be included. The probability of developing therapy-associated side effects is significantly increased if the patient is already in a limited general condition, also known as fragility, before the therapy. In addition, due to demographic change, the incidence of head and neck tumors will continue to increase, especially in patients of advanced age. Due to their age, other pre-existing conditions and infirmity, they are at a further increased risk of therapy-related side effects In order to improve the care of patients with head and neck tumors, we must first determine how many patients are affected by fragility. In addition, we want to determine influencing factors that are associated with fragility. These include, for example, difficulty swallowing and weight loss. Based on this data, we will then plan the implementation of an intervention study to establish a prehabilitation program.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Geriatric Assessment | Experimental | Other: Geriatric AssessmentFrailty is assessed using the G8 questionnaire. Secondary objectives include the assessment of quality of life and financial burden (EORTC-QLQ C30+ H\&N43), swallowing function, cardiopulmonary resilience (6-minute walk test) and the patient's wishes regarding a prehabilitation program. Epidemiological and disease-related data is also collected. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Indication for curative therapy in the case of an initial diagnosis of head and neck tumor disease
- Capacity to consent
- At least 18 years of age
- Sufficient knowledge of the German language
Key exclusion criteria (11 listed)
- - Lack of capacity to consent
- Age <18 years
- Severe impairment of walking ability that makes it impossible to perform the 6MWT safely
- Absolute contraindications for the procedure are
- unstable angina pectoris
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Geriatric AssessmentFrailty is assessed using the G8 questionnaire. Secondary objectives include the assessment of quality of life and financial burden (EORTC-QLQ C30+ H\&N43), swallowing function, cardiopulmonary resilience (6-minute walk test) and the patient's wishes regarding a prehabilitation program. Epidemiological and disease-related data is also collected. | Other | Geriatric Assessment |
Primary outcome
Frailty
Time frame: once prior to surgery or at beginning of radiation
Assessment via G8 (Geriatric Screening Tool) questionnaire consists of 8 questions. The score ranges from 0 (poor score) to 17 points (good score), and a score of 11 or lower indicated frailty, whereas a score between 12 and 14 equals pre-frail patients. Patients with a score above 14 are considert non-frail.
6 secondary outcomes
EORTC-QLQ C30 questionnaire
Time frame: prior to surgery or at beginning of radiotherapy
swallowing function
Time frame: prior to surgery or beginning of radiation
Cardio-pulmonary resilience
Time frame: prior to surgery or beginning of radiation
Epidemiologic Data
Time frame: prior to surgery or beginning of radiation
Information on current tumor disease
Time frame: prior to surgery or beginning of radiation
EORTC-H&N43 questionnaire
Time frame: prior to surgery or at beginning of radiotherapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Geriatric Assessment in people with Head and Neck Cancers, 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 11 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: finished, as of the sponsor's last update on 28 Aug 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frailty (time frame: once prior to surgery or at beginning of radiation). 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 28 Aug 2025.