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Not Yet Recruiting NCT07857096

Rehabilitation Through Individualized Support and Exercise

Conditions: Oral Cancer, Head and Neck Cancer

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 39
Sponsor: Universitaire Ziekenhuizen KU Leuven

Location: UZ Leuven Leuven

Summary

Oral cancer, the most prevalent form of head and neck malignancy, represents a major global health burden, with over 370,000 new cases annually according to the World Health Organization. Surgical resection with free flap reconstruction remains the gold standard for curative treatment, yet it often entails significant functional and physical impairment. The surgical procedure often involves tumor resection and reconstruction. Postoperative complications such as dysphagia, reduced masticatory function, and prolonged immobility frequently contribute to fatigue, loss of muscle mass, and delayed recovery, ultimately impacting quality of life and overall prognosis. Loss of skeletal muscle mass, commonly observed in this patient population, is strongly associated with impaired physical performance, reduced treatment tolerance, and increased postoperative morbidity. Recent evidence underscores that early mobilization and structured physiotherapeutic interventions can mitigate these effects, enhance functional recovery, and reduce length of hospital stay across various surgical populations. In head and neck cancer specifically, early mobilization has been associated with shorter hospitalization and fewer complications, yet practical, standardized physiotherapy protocols remain scarce and poorly defined. Despite inclusion of early mobilization principles in Enhanced Recovery After Surgery (ERAS) pathways, current head and neck cancer guidelines lack specific recommendations regarding the timing, intensity, and content of postoperative physical activity. Furthermore, evidence on patient compliance and feasibility of such interventions during the acute hospitalization phase is limited.

Eligibility Criteria

Inclusion criteria: * Age ≥18 years. * Histologically confirmed oral cancer. * Planned free fibula or DCIA flap reconstruction. * Ability to provide written informed consent. * Sufficient comprehension of Dutch to complete questionnaires. Exclusion criteria: * Severe psychiatric or neurocognitive impairment (e.g., dementia, Korsakoff syndrome, schizophrenia). * Hemodynamic instability or contraindication to mobilization. * Pre-existing neuromuscular disorders severely limiting mobility.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07857096). StuddyBuddy aggregates publicly available trial information.