HRQoL in Patients With Solid Tumors Treated With Hadrontherapy

Head and Neck Cancer Clinical Trial

— HadroQoL  

Official title:

Health Related Quality of Life (HRQoL) in Patients With Solid Tumors Treated With Hadrontherapy (HadroQoL).

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05947149
• Other study ID #: CNAO OSS 52 2022
• Status: Recruiting
• Start date: March 27, 2023
• Est. completion date: March 26, 2025

Study information

• Verified date: July 2023
• Source: CNAO National Center of Oncological Hadrontherapy
• Contact: Anna Maria Camarda
• Phone: +390382078501
• Email: camarda[@]cnao.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The Quality of Life of patients treated with hadrontherapy is still limited. Two cohorts are established, they will be receiving specific standardized questionnaires to be evalutaed in their results.

Description:

Since 2011, CNAO has been treating patients suffering from solid tumors with particle therapy (both protons and carbon ions). Hadrontherapy improves outcome of radioresistant tumors which normally do not benefit from conventional radiotherapy. The treated population is highly heterogenous in term of tumor site, histotype, treatment fields and doses however its common anatomical origin justifies a unified approach in evaluating a QoL in this setting. QoL of patients suffering from these tumors have been poorly investigated and there are still few studies on patient reported outcomes (PROs) and QoL following hadrontherapy. In this context, therefore, there is a need to generate data by designing distinct cohort studies, conceived within a single protocol, that will gather quality of life data by means of standardized questionnaires of patients along their oncological history. Thanks to this protocol design, the investigator will be facilitated, in the future, in adding new cohorts pending a study protocol amendment and ethical approval.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: March 26, 2025
• Est. primary completion date: March 26, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Cohort A ("survivors"):

Inclusion Criteria

• Patients with at least a follow up of 5 years with head and neck, skull base and brain tumors and no evidence of progressive disease.

• The patient is able to give consent

Exclusion Criteria:

• Re-irradiation.

• Second tumor.

• Known cases of any psychiatric and neurological diseases leading to disability (eg, manic disorder, schizophrenia etc..), which could impair compilation of questionnaires or affect quality of life.

Cohort B:

Inclusion Criteria:

• Histological and/or radiological diagnosis of head and neck tumors

• Patients candidate for curative intent hadrontherapy

• Patients = 18 years of age

• The patient is able to give consent

Exclusion criteria:

• Re-irradiation.

• Second tumor

• Known cases of any psychiatric and neurological diseases leading to disability (eg, manic disorder, schizophrenia etc..), which could impair compilation of questionnaires or affect quality of life

• Presence of diffused metastasis

Related Conditions & MeSH terms

• Brain Cancer
• Brain Neoplasms
• Head and Neck Cancer

Intervention

Other:
• questionnaires administration
Enrolled people will be requested to fill in questionnaires. Cohort A affected by head and neck cancer: SF-12, EORTC QLQ-C30, EORTC QLQ-H&N43, HADS, Brief COPE, BRCS. Cohort A affected by skull base/brain cancer: SF-12, EORTC QLQ-BN20, HADS, Brief COPE, BRCS. Cohort B will receive: EORTC QLQ-C30, BRCS, PROFFIT, SF-12, EORTC QLQ-H&N43.

Locations

Country	Name	City	State
Italy	CNAO	Pavia	Pv

Sponsors (1)

Lead Sponsor	Collaborator
CNAO National Center of Oncological Hadrontherapy

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	quality of life assessment	quality of life in subjects treated with curative hadrontherapy investigated by global score according to SF12 and compared to healthy population	5 years follow uo after hadrontherapy
Secondary	quality of life assessment related also to psychological variables, socio-cognitive facors, resilience	quality of life in subjects treated with curative hadrontherapy investigated by global score according to EORTC QLQ-C30	before treatment and after 1 year from treatment completion