Clinical trial · Observational
Acute and Long-term Impact of Cancer Treatment on Head and Neck Cancer Patients: FIT4TREATMENT
Acute and Long-term Impact of Cancer Treatment on Quality-of-life, Physical and Cognitive Function of Head and Neck Cancer Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): COVID-19 pandemic
Summary
Brief summary (as posted)
Head and Neck Squamous Cell Carcinoma (HNSCC) is the 6th most common cancer. Most cases are diagnosed in locally advanced stages, with treatment involving multimodal approach with combinations of radiotherapy, surgery and chemotherapy. The aggressive nature of HNSCCs and treatment modalities are associated with important acute and late toxicities that often promote temporary or definitive treatment interruption and may compromised the capability to tolerate subsequent treatments. Thus, the aim of this study is to analyze the acute and long-term impact of cancer treatment on quality of life, physical and cognitive function of HNSCC patients diagnosed with a locally advanced disease.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Neoplasms | Head and Neck Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Quality of life (acute)
- timeFrame
- Change of global quality of life score from baseline to the end of treatment
- description
- Global quality of life score evaluated by EORTC QLQ-C30 questionnaire (range in score from 0 to 100, high score represents a high level of functioning)
- measure
- Quality of life (long-term)
- timeFrame
- Change of global quality of life score from baseline to 4 months after the treatment is completed
- description
- Global quality of life score evaluated by EORTC QLQ-C30 questionnaire (range in score from 0 to 100, high score represents a high level of functioning)
Secondary outcomes (25)
- measure
- Fatigue (acute)
- timeFrame
- Change of fatigue score from baseline to the end of treatment
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients older than 18 years. * Diagnosis of locally advanced head and neck cancer (oral cavity, oropharynx, hypopharynx, larynx), stage III-IVB. * Proposed for primary treatment with curative intent - surgery or induction chemotherapy before chemoradiotherapy (CRT) or CRT alone. Exclusion Criteria: * Synchronous tumors or other comorbidities with associated uncontrolled symptoms. * Inability to provide informed consent. * Expected inability to fulfil the propose schedule and follow-up.
References
Publications (0)
Data not yet available