HRQoL in Patients With Solid Tumors Treated With Hadrontherapy

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05947149
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	CNAO National Center of Oncological Hadrontherapy
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Anna Maria Camarda
Principal Investigator Affiliation	CNAO National Center of Oncological Hadrontherapy
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Italy
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Head and Neck Cancer, Skull Base--Cancer, Brain Cancer

Additional Details

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.

Arms & Interventions

Arms

: Cohort A Survivors

about 80 patients with at least a 5 year follow up with head and neck, skull base and brain tumors and no evidence of progressive disease.

: Cohort B

100 patients with histological and/or radiological diagnosis of head and neck tumors enrolled at baseline

Interventions

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

CNAO, Pavia, Pv, Italy

Status

Recruiting

Address

CNAO

Pavia, Pv, 27100

Site Contact

Cristina Bono, MSc

[email protected]

0382078613

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