Integrated Early-CARE for Head & Neck Cancer.

NCT07671573 | Not Yet Recruiting DMC

• 1 other identifier: 13/2026
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Head & Neck Cancer; Locally Advanced Head and Neck Cancer; Squamous Cell Carcinoma Head and Neck Cancer (HNSCC)

Keywords

chemoradiotherapy; Cancer; Palliative care; Locally advanced Head and neck cancer; Squamous Cell Carcinoma of the Head and Neck; Edmonton Symptom Assessment System (ESAS); Head and neck Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• ESAS-R score #1 (cross comparison)

  Patient-reported evaluation of 9 relevant symptoms (pain, fatigue, somnolence, nausea, loss of appetite, dyspnea, depression, anxiety and well-being) and an open section for reporting "other problems", using a scale from 0 (no symptom) to 10 (maximum intensity symptom) for every symptom. The final score is obtained by summing all symptom evaluations (ranging from 0-100). Aim: To determine the impact of early integration of outpatient palliative care alongside chemoradiotherapy on the symptom burden of patients. It will be assessed in both study groups (control and intervention). Note: ESAS-R tool includes a final body diagram allowing participants to indicate the location of pain.

  12 weeks after inclusion in the study

Secondary Outcomes (14)

• ESAS-R score #2 (cross/longitudinal comparison)

  12 weeks after inclusion in the study

• Hospitalisation occurrence Type 1 (CTC-AE =>3)

  It will comprise 5 compulsory timepoints: (1)CRT-day 1, (2)CRT-day 22, (3)CRT-day 49, (4)up to 7 weeks- end of CRT, (5)12 weeks post-inclusion; and two optional timepoints: (1)6 months after inclusion and (2)12 months after inclusion.

• Hospitalisation occurrence Type 2 (CTC-AE =>3)

  It will comprise 5 compulsory timepoints: (1)CRT-day 1, (2)CRT-day 22, (3)CRT-day 49, (4)up to 7 weeks- end of CRT, (5)12 weeks post-inclusion; and two optional timepoints: (1)6 months after inclusion and (2)12 months after inclusion.

• Hospitalisation occurrence Type 3 (CTC-AE =>3)

  It will comprise 5 compulsory timepoints: (1)CRT-day 1, (2)CRT-day 22, (3)CRT-day 49, (4)up to 7 weeks- end of CRT, (5)12 weeks post-inclusion; and two optional timepoints: (1)6 months after inclusion and (2)12 months after inclusion.

• Hospitalisation occurrence Type 4 (CTC-AE =>3)

  It will comprise 5 compulsory timepoints: (1)CRT-day 1, (2)CRT-day 22, (3)CRT-day 49, (4)up to 7 weeks- end of CRT, (5)12 weeks post-inclusion; and two optional timepoints: (1)6 months after inclusion and (2)12 months after inclusion.

Study Arms (2)

Control Group (CRT)

NO INTERVENTION

Patients receiving standard-of-care treatment with isolated chemoradiotherapy

Interventional Group (CRT + early palliative care)

EXPERIMENTAL

Patients receiving outpatient palliative care concurrently with standard chemoradiotherapy. In the intervention arm, the first palliative care consultation must be scheduled within 28 days of signing the informed consent form and must coincide with the day of the first cycle of cisplatin chemotherapy and radiotherapy. The second consultation will take place between the 3rd and 7th week of treatment (D+22 to D+49). The third consultation will be conducted after completion of CRT (7th week) through to the 9th week. The fourth consultation will take place 12 weeks after study enrolment (primary outcome). Two long-term follow-up assessments (every 6 months) may be conducted either in person or remotely. Additional consultations will be at the discretion of the patient, the primary caregiver, the oncologist, and the palliative care physician.

Behavioral: Early palliative care integration

Interventions

Early palliative care integration BEHAVIORAL

In the intervention arm, the first palliative care consultation must be scheduled within 28 days of signing the informed consent form and must coincide with the day of the first cycle of cisplatin chemotherapy and radiotherapy. The second consultation will take place between the 3rd and 7th week of treatment (D+22 to D+49). The third consultation will be conducted after completion of CRT (7th week) through to the 9th week. The fourth consultation will take place 12 weeks after study enrolment (primary outcome). Two long-term follow-up assessments (every 6 months) may be conducted either in person or remotely. Additional consultations will be at the discretion of the patient, the primary caregiver, the oncologist, and the palliative care physician.

Also known as: Outpatient palliative care

Interventional Group (CRT + early palliative care)

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• Each patient will be excluded if they meet any of the following criteria:
• ECOG performance status 3-4;
• Previous follow-up by specialised palliative care;
• Primary tumours of the nasopharynx, oesophagus, lip, or salivary glands;
• Metastatic head and neck cancer (oral cavity, oropharynx, larynx, and hypopharynx);
• 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;
• Diagnosis of dementia;
• Participation in another clinical trial.

Sponsors & Collaborators

• Portuguese Oncology Institute, Coimbra: lead
• Unidade Local de Saúde de Coimbra, EPE: collaborator
• Instituto Portugues de Oncologia, Francisco Gentil, Porto: collaborator
• Hospital do Divino Espírito Santo de Ponta Delgada: collaborator
• University of Coimbra: collaborator

Study Sites (1)

Department of Medical Oncology (Portuguese Oncology Institute of Coimbra)-Portuguese Oncology Institute of Coimbra- Av. Bissaya Barreto 98, Celas, 3000-075 Coimbra

Coimbra, Coimbra District, 3000-075, Portugal

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck; Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Maria Margarida Teixeira, MD

  Portuguese Oncology Institute of Coimbra

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Margarida Teixeira, MD

CONTACT

+351239400200; mtmargaridateixeira@gmail.com

Clinical Trials Unit - Coimbra Academic Clinical Center CTU-CACC

CONTACT

+351 239 400 400; ctu-cacc@ulscoimbra.min-saude.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Oncologist

Model Details: In the intervention arm, the first palliative care consultation must be scheduled within 28 days of signing the informed consent form, and must coincide with the day of the first cycle of cisplatin chemotherapy and radiotherapy. The second consultation will take place between the 3rd and 7th week of treatment (D+22 to D+49). The third consultation will be conducted after completion of CRT (7th week) through to the 9th week. The fourth consultation will take place 12 weeks after study enrolment (primary outcome). Two long-term follow-up assessments (every 6 months) may be conducted either in person or remotely. Additional consultations will be at the discretion of the patient, the primary caregiver, the oncologist, and the palliative care physician.

Study Record Dates

• First Submitted: June 17, 2026
• First Posted: June 26, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): March 31, 2028
• Last Updated: June 26, 2026

Record last verified: 2026-06

Locations

PT (1)