Integrated Early-CARE for Head & Neck Cancer.

A vizsgálat adatai

Ki végzi

Portuguese Oncology Institute, Coimbra

Azonosító

NCT07671573

A regiszteradat frissítve

2026. június 26.

Eredeti leírás

In Portugal, approximately 2,424 new cases of head and neck cancer are diagnosed each year, of which 60% are already at an advanced stage, presenting with intense pain and dysphagia (difficulty swallowing). There is also marked social isolation due to communication difficulties, economic hardship, and facial disfigurement (altered facial appearance). As a result, patients frequently face challenges in accessing specialised palliative care services, encountering delays, fragmentation, or a complete absence of such care.A teljes eredeti leírásKevesebb

Randomized Multicenter Clinical Trial of Early Integration of Palliative Care With Chemoradiotherapy Versus Chemoradiotherapy Alone in Patients With Locally Advanced Unresectable Head and Neck Cancer.

In Portugal, approximately 2,424 new cases of head and neck cancer are diagnosed each year, of which 60% are already at an advanced stage, presenting with intense pain and dysphagia (difficulty swallowing). There is also marked social isolation due to communication difficulties, economic hardship, and facial disfigurement (altered facial appearance). As a result, patients frequently face challenges in accessing specialised palliative care services, encountering delays, fragmentation, or a complete absence of such care.

The i-CARE-HN study is the solution: investigators aim to integrate outpatient palliative care with oncological treatment -namely chemoradiotherapy -at an earlier stage of the disease-when it is still limited to the throat and neck region, without metastasis (spread to other organs). This means multidisciplinary support from the outset of oncological treatment - symptom control, psychological support, and quality of life - without delaying the cure. It is like giving the patient a 'shield' against suffering, enabling them to complete treatment more efficiently.

In the i-CARE-HN study, early palliative care aims to better manage patients' symptoms (such as pain, difficulty speaking, swallowing, breathing, dry mouth, loss of appetite, and anxiety), to clarify doubts, to support therapeutic decisions, and to strengthen communication between the patient and the team, without replacing the primary oncological treatment. Rather than waiting for symptoms to worsen before seeking help, this support will be provided throughout treatment with chemotherapy and radiotherapy. Through this simultaneous integration of outpatient palliative care into oncological treatment, investigators hope to improve patients' symptoms and quality of life, as well as clinical outcomes: fewer treatment interruptions, improved treatment tolerability, fewer emergency hospitalisations, and greater overall survival. Investigators will want to know how patients are feeling throughout the process, and to that end, will invite them to complete a survey at several points during the study. Responses to the questionnaires are critical to enabling the medical team to rapidly identify which participating patients present with the most significant symptoms and the greatest risk of complications.

This study plans to recruit 64 patients aged 18 years or older, with a recent diagnosis of locally advanced, inoperable cancer, being followed on an outpatient basis at the IPO de Coimbra, IPO do Porto, and ULS de Coimbra, who will be invited to participate in the study. Should the patient agree to participate, some baseline data will be collected, and patients will subsequently be randomly assigned to one of two groups: one group will receive isolated chemoradiotherapy (standard treatment: cisplatin 100 mg/m² every 3 weeks- days 1, 22, and 49- and daily radiotherapy 70 Gy in 35 fractions over 7 weeks) and the other group will receive chemoradiotherapy alongside palliative care, on an outpatient basis (access to palliative care consultations). Patients randomised to the standard treatment group (chemoradiotherapy without a structured early palliative care intervention) will not have palliative care appointments systematically scheduled. However, should a referral to palliative care be requested, the patient may be directed to that clinical department.

Bevonási feltételek: Each patient must fulfil all of the following criteria:; Diagnosis of locally advanced (unresectable) head and neck squamous cell carcinoma (HNSCC) of the oral cavity, oropharynx, larynx, and hypopharynx, staged according to the TNM AJCC 8th edition, proposed at a multidisciplinary team (MDT) meeting for definitive chemoradiotherapy (CRT) on an outpatient basis; Age ≥18 years; ECOG performance status 0-2; Adequate organ function: haemoglobin ≥9 g/dL; neutrophils ≥1.5×10⁹/L; platelets ≥100×10⁹/L; creatinine ≤1.5×ULN; bilirubin, AST, ALT, LDH ≤1.5×ULN; Signed informed consent by the participant.

Kizáró feltételek: Previous follow-up by specialised palliative care; Metastatic head and neck cancer (oral cavity, oropharynx, larynx, and hypopharynx); Diagnosis of dementia; Severe comorbidities: decompensated cardiovascular disease (NYHA class III/IV heart failure, recent myocardial infarction), severe COPD (FEV₁ <50% predicted), renal insufficiency (eGFR <30 mL/min), hepatic insufficiency (Child-Pugh B/C); Laboratory values: neutrophils <1.5×10⁹/L, platelets <100×10⁹/L, haemoglobin <9 g/dL, creatinine >1.5×ULN; Each patient will be excluded if they meet any of the following criteria:; ECOG performance status 3-4; Primary tumours of the nasopharynx, oesophagus, lip, or salivary glands; Participation in another clinical trial.

ClinicalTrials.gov NCT07671573