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Quality of Life and Psycological Evaluation of Patients Affected by Head and Neck Cancer

Withdrawn
Conditions
Quality of Life
Interventions
Radiation: Head and Neck patients
Registration Number
NCT02984033
Lead Sponsor
Michele Tedeschi
Brief Summary

The prospective trial is to describe the quality of life and psychological effects in patients with head and neck tumor receiving curative intent treatment

Detailed Description

The multicentric prospective trial is to evaluate the quality of life and psychological effects in patients with head and neck tumor treated by curative intent radiation therapy. The treatment consists in a conventionally fractionated Intensity Modulated Radiotherapy (IMRT) or until 2.2 Gy per fraction with a total dose of 50-66 Gy in post-operative setting and 66-72 Gy in radical setting.

Recruitment & Eligibility

Status
WITHDRAWN
Sex
All
Target Recruitment
Not specified
Inclusion Criteria
  • Squamous cell carcinoma of head and neck (oral cavity, larynx, pharynx and hypopharynx) in non-metastatic staging;
  • curative intent treatment (radiation therapy associated or not to chemotherapy; surgery associated or not to post-operative radiotherapy and chemotherapy);
  • performance status < 2;
  • age ≥ 18 years;
  • good knowledge of italian language;
  • written informed consent
Exclusion Criteria

Not provided

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Head and Neck patientsHead and Neck patientsPatients affected by squamous cell carcinoma of head and neck (oral cavity, larynx, pharynx and hypopharynx) with no metastasis
Primary Outcome Measures
NameTimeMethod
Quality of life and psychological effetcs evaluated by patient reported outcome (PRO)18 months
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Humanitas Research Hospital

🇮🇹

Rozzano, Milano, Italy

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