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

NCT ID: NCT02984033

Last Updated: 2018-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2016-11-30

Study Completion Date

2018-02-01

Brief Summary

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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

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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.

Conditions

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Quality of Life

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Head and Neck patients

Patients affected by squamous cell carcinoma of head and neck (oral cavity, larynx, pharynx and hypopharynx) with no metastasis

Head and Neck patients

Intervention Type RADIATION

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.

Interventions

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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.

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Michele Tedeschi

OTHER

Sponsor Role lead

Responsible Party

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Michele Tedeschi

Medical Doctor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Ciro Franzese, MD

Role: STUDY_CHAIR

Humanitas Cancer Center

Locations

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Humanitas Research Hospital

Rozzano, Milano, Italy

Site Status

Countries

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Italy

Other Identifiers

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1642

Identifier Type: -

Identifier Source: org_study_id

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