Neoplasms

All Conditions

Nervous System Diseases

Symptoms and General Pathology

Rare Diseases

Head and Neck Neoplasms

Sarcopenia

Atrophy

Muscular Atrophy

Neuromuscular Manifestations

Neurologic Manifestations

Pathological Conditions, Anatomical

Acute Graft Versus Host Disease

Anti-Inflammatory Agents

Antirheumatic Agents

Analgesics

All Drugs and Chemicals

Chrysarobin

the patient is administered with questionnaires focused on diet, fatigue, nutrition screening and on body mass index at the beginning and at the end pf particle therapy radiation treatment

questionnaires QLQ-FA12, Mini Nutritional Assessment Short Form, Nutritional Risk Screening, diet questionnaire of frequency, ,body mass index measurement

as per clinical routine, hemoglobin, lymphocytes, albumin and NLR will be collected

blood biomarkers

Rossana Ingargiola, MD

Cristina Bono, MSc

The study focuses on the impact of sarcopenia on acute and late toxicities in head and neck tumor affected patients treated with particle therapy.

To evaluate in HNC patients treated with particle therapy the impact of SP (measured by low skeletal muscle mass at the C3 vertebral body) on toxicity profile assessed according to NCI's Common Terminology Criteria for Adverse Events CTCAE (version 5.0), defined as:

* Acute toxicity: within 3 months from the beginning of particle RT
* Late toxicity: more than 6 months after the end of particle RT. To investigate possible association between SP and nutritional

Sarcopenia in Head and Neck Cancer Patients Treated With Curative Hadrontherapy

Role of Baseline Sarcopenia in Determining Acute Toxicity for Head and Neck Cancer Patients Treated With Curative Hadrontherapy: a Prospective Monoinstitutional Study

measurement of sarcopenia to evaluate the development of the affection

CNAO National Center of Oncological Hadrontherapy

Behaviors and Mental Disorders

Brain Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Quality of Life

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.

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

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.

questionnaires administration

Anna Maria Camarda

Cristina Bono

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.

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.

HRQoL in Patients With Solid Tumors Treated With Hadrontherapy

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

quality of life in subjects treated with curative hadrontherapy investigated by global score according to SF12 and compared to healthy population

quality of life in subjects treated with curative hadrontherapy investigated by global score according to EORTC QLQ-C30

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Sarcopenia in Head and Neck Cancer Patients Treated With Curative Hadrontherapy	NCT06207708	Head and Neck C...	questionnaires ... blood biomarker...	18 Years -	CNAO National Center of Oncological Hadrontherapy
Sarcopenia in Head and Neck Cancer Patients Treated With Curative Hadrontherapy	NCT06207708	Head and Neck C...	questionnaires ... blood biomarker...	18 Years -	CNAO National Center of Oncological Hadrontherapy
HRQoL in Patients With Solid Tumors Treated With Hadrontherapy	NCT05947149	Head and Neck C... Skull Base--Can... Brain Cancer	questionnaires ...	18 Years -	CNAO National Center of Oncological Hadrontherapy

Spots Global Cancer Trial Database for hadrontherapy