Value of Geriatric Screening to Predict Postoperative Morbidity for Head and Neck Cancer

NCT ID: NCT03053310

Last Updated: 2024-08-09

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 94 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-01-25
• Study Completion Date: 2025-02-28

Brief Summary

Background Approximately half of head and neck cancer patients are 65 years or older at diagnosis. Treatment decisions in this older HNCA population are challenging, because of the lack of evidence-based guidelines. Surgery is often the treatment of choice in a HNCA setting where curative treatment is intended. Though chronological age per se has not been reported as a contraindication for surgery, data are limited and often the result of retrospective studies. Measurement of functional age, through a comprehensive geriatric assessment, has been suggested by several international cancer organizations to be a better prognostic indicator. At the divisions of maxillofacial surgery and otorhinolaryngology, a geriatric assessment is part of routine preoperative staging for patients of 70 years old or older.

Objectives The investigators aim to determine the value of G8 to predict 30-day postoperative comorbidity in an older HNCA population undergoing elective curative surgery. Moreover, they aim to examine the vulnerability profile of patients undergoing elective head and neck surgery for an oncology diagnosis.

Study design All patients of 70 years and older, presenting at the divisions of maxillofacial surgery and otorhinolaryngology for curative surgery of a solid head and neck tumour undergo a geriatric consult as part of routine preoperative staging. The presence of postoperative morbidity and mortality within the first 30 days after surgery will be collected as a primary endpoint.

At 30±10 days postoperative, all patients will be re-evaluated with the G8 and the CGA. Patient' quality of life will also be re-examined within 30 days postoperative and again at 6 and 12 months postoperative.

Conclusion There is still no consensus whether older HNCA patients should receive a different treatment compared to younger patients. Data related to the vulnerability profile of older patients requiring HN surgery, and the predictive value of geriatric screening for postoperative morbidity could enable better patient selection in the future.

Conditions

Head and Neck

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Primary (P) - group

• Patients with a primary diagnosis
• Patients treated with curative intent (stage I-IVb)

No interventions assigned to this group

Relapse (R) - group

• Patients with a recurrent (loco)regional tumour
• Patients treated with curative intent (stage I-IVb)

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• - Patients aged 70 years or older at time of enrolment
• Both female and male patients
• Patients that are Dutch or French-speaking
• Patients with a histologically confirmed malignant tumour in the head and neck region, in specific oral cavity, larynx, and pharynx ('head and neck cancer', defined according to the NCCN guidelines)
• Patients undergoing surgery for a solid head and neck cancer tumour under general anaesthesia. Preoperative data from patients considered ineligible for surgery, will also be registered for scientific purposes
• Patients undergoing surgery and follow-up care at the division of maxillofacial surgery or Department of Otorhinolaryngology, Head and Neck Surgery

Exclusion Criteria

• - Patients not eligible according to the abovementioned criteria
• Patients with a spinocellular carcinoma of the skin
• Patients with distant metastases (stage IVc)
• Patients with another non-cured cancer, except for a squamous or basal cell carcinoma of the skin
• Patients arriving at the emergency department for urgent surgical intervention
• Patients diagnosed with severe dementia, according to the DSM IV or MMSE ≤18, or diagnosed psychiatric problems impeding proper preoperative assessment

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AZ Sint-Jan AV

OTHER

Sponsor Role: lead

Responsible Party

Johan Abeloos

head of department of maxillofacial surgery, principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Johan Abeloos, MD

Role: PRINCIPAL_INVESTIGATOR

AZ Sint-Lucas Brugge

Locations

AZ Sint-Jan Brugge-Oostende AV

Bruges, , Belgium

Countries

Belgium

Other Identifiers

B049201629484

Identifier Type: -

Identifier Source: org_study_id