Prospective Evaluation of Frailty in Patients With Head and Neck Tumors Before Curative Intended Therapy

NCT06638216 | Completed

• 1 other identifier: EA1/168/24
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Cancers

Keywords

Head and Neck Cancer; Frailty; Geriatric Assessment; Radiation; Maxillo-facial Surgery

Outcome Measures

Primary Outcomes (1)

• 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.

  once prior to surgery or at beginning of radiation

Secondary Outcomes (6)

• EORTC-QLQ C30 questionnaire

  prior to surgery or at beginning of radiotherapy

• swallowing function

  prior to surgery or beginning of radiation

• Cardio-pulmonary resilience

  prior to surgery or beginning of radiation

• Epidemiologic Data

  prior to surgery or beginning of radiation

• Information on current tumor disease

  prior to surgery or beginning of radiation

Study Arms (1)

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.

Other: Geriatric Assessment

Interventions

Geriatric Assessment OTHER

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.

Geriatric Assessment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Charité University Medicine Berlin

Berlin, State of Berlin, 13353, Germany

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Frailty

Interventions

Geriatric Assessment

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Status; Demography; Population Characteristics; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor for Experimental Radiation Oncology

Study Record Dates

• First Submitted: October 6, 2024
• First Posted: October 15, 2024
• Study Start: October 7, 2024
• Primary Completion: June 12, 2025
• Study Completion: June 12, 2025
• Last Updated: August 28, 2025

Record last verified: 2025-08

Locations

DE (1)