Clinical trial NCT06638216: Prospective Evaluation of Frailty in Patients with Head and Neck Tumors Before Curative Intended Therapy
Official title: Prospective Evaluation of Frailty in Patients with Head and Neck Tumors Before Curative Intended Therapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Head and Neck Cancers
Keywords: Head and Neck Cancer
Frailty
Geriatric Assessment
Radiation
Maxillo-facial Surgery
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* - 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
* 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.

Primary outcomes:
measure: Frailty
timeFrame: once prior to surgery or at beginning of radiation
Secondary outcomes:
measure: EORTC-QLQ C30 questionnaire
timeFrame: prior to surgery or at beginning of radiotherapy
measure: swallowing function
timeFrame: prior to surgery or beginning of radiation
measure: Cardio-pulmonary resilience
timeFrame: prior to surgery or beginning of radiation
measure: Epidemiologic Data
timeFrame: prior to surgery or beginning of radiation
measure: Information on current tumor disease
timeFrame: prior to surgery or beginning of radiation
measure: EORTC-H&N43 questionnaire
timeFrame: prior to surgery or at beginning of radiotherapy
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité University Medicine Berlin
Study officials:
References: