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

Quality of Life Clinical Trial

Official title:

Quality of Life and Psychological Evaluation of Patients Affected by Head and Neck Cancer Treated With Curative Intent: Multicentric Prospective Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02984033
• Other study ID #: 1642
• Status: Withdrawn
• Start date: November 2016
• Est. completion date: February 1, 2018

Study information

• Verified date: October 2018
• Source: Istituto Clinico Humanitas
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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 information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 1, 2018
• Est. primary completion date: February 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Neoplasms
• Quality of Life

Intervention

Radiation:
• Head and Neck patients
Treatment consists of Intensity Modulated Radiation Therapy (until 2.2 Gy) with a total dose of 50-66 Gy in post-operative setting and 66-72 Gy in radical setting.

Locations

Country	Name	City	State
Italy	Humanitas Research Hospital	Rozzano	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Michele Tedeschi

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life and psychological effetcs evaluated by patient reported outcome (PRO)		18 months