Infections

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Symptoms and General Pathology

COVID-19

Communicable Diseases

Coronavirus Infections

Pneumonia

Pneumonia, Viral

Respiratory Tract Infections

Virus Diseases

Coronaviridae Infections

Nidovirales Infections

RNA Virus Infections

Lung Diseases

Respiratory Tract Diseases

* confirmation of COVID-19 in the laboratory (RT-PCR techniques);
* suspected cases of COVID-19; clinically diagnosed based on symptoms (fever\> 37.5 °, decrease in oximeter saturation by at least 5%, cough, diarrhea, otitis, dysgeusia, myalgia, arthralgia, conjunctivitis and rhinorrhea) + close contact a COVID-19 subject positive;
* asymptomatic cases; diagnosed based on positive swab results but without symptoms

No intervention on patients

Data Manager Oncology Unit

Giuseppe Di Lorenzo

It's an obsevational retrospective/prospective study. Analyzing the evolution of COVID 19 infection in cancer patients can provide interesting information in the management of these patients. For this reason, the purpose of this study is to implement a registry to describe and monitor cancer patients affected by COVID 19, the factors that are associated with an unfavorable evolution, to develop a strategy for the risk assessment of these patients and recommendations. relating to their treatment.

Particular attention will be paid to patients suffering from urological tumors because the treatment followed by the patients would seem to expose them to a greater risk when they are infected with coronavirus, furthermore, from the literature it is clear that there may be a connection between sex hormones and ACE2 levels in the plasma. In fact, the estrons up-regulate the concentration of ACE2 in the circulation and this could be the reason why women would seem more protected than men once they contract the coronavirus infection

Primary objectives:

* describe cancer patients with COVID-19 and their clinical course;
* identify predictors of the most severe clinical course;
* identify prognostic factors; Secondary objectives
* Monitor patients with urological tumors with particular attention;
* Dosing parameters of inflammation such as IL-6 and IFNα;
* Measure the ACE2 levels.

Patients with oncological pathology who contracted COVID 19 infection from January 1, 2020 until the WHO declaration of the end of the pandemic will be studied.

COVID-19 Infection in Cancer Pantients

Clinical Course of Cancer Patients Who Contracted COVID 19 Infection: An Observational Study

Describing cancer patients with COVID-19 and their clinical course will help us to identify predictors of the most severe clinical course and also prognostic factors

Ospedale Andrea Tortora di Pagani

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Heart and Blood Diseases

Substance Related Disorders

Wounds and Injuries

Carcinoma

Prostatic Neoplasms

Hypertension

Cardiotoxicity

Vascular Diseases

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Heart Diseases

Drug-Related Side Effects and Adverse Reactions

Chemically-Induced Disorders

Radiation Injuries

CRPC patients without evidence of distant metastasis are eligible

No Intervention on patients

This is a prospective observational study on a cohort of patients with castration-resistant prostate cancer M0, treated with Apalutamide, at the Oncology Unit of the "Andrea Tortora" Hospital of Pagani. Data will be collected on the patient's clinical history and the treatments carried out until the start of therapy with Apalutamide. At that time the study will be described to the patient and informed consent will be given.

In case of a favorable opinion from the patient, the CRF will be filled in. Patients with CRPC M0 treated with Apalutamide, belonging to the Oncology Unit of the Pagani Hospital "Andrea Tortora" and of the other Oncology Units of the ASL of Salerno (Hospital of Vallo della Lucania) will be studied with the possibility of enrollment also from other Centers outside the Salerno ASL.

The CRPC M0 patient will be identified by PET PSMA, or CT scan and Bone Scanning at the clinician's discretion based on the physical examination performed at the patient's first access. The reassessment of the disease status is to be repeated by PET-PSMA, CT scan or bone scan (in relation to the examination carried out at baseline) in a period of time ranging from 6 to 12 months after the first access, based on the assessment of the health status of the patient and tolerability to treatment after careful evaluation by the clinician. The blood chemistry routine including CBC with white blood cell formula will be repeated every 30 days. The patient will be provided with a blood pressure monitoring diary every 30 days. The measurement of cardiac markers will be performed every 60 days. The evaluation of the cardiological function will be carried out by means of ECG, echocardiography with determination of the LVEF, 24-hour Holter blood pressure every 6 months. Bone mineral density assessment will be monitored by MOC-DEXA every 6 months. Possible drug interactions with Apalutamide will be identified.

Primary objective:

-Evaluation of arterial hypertension, by periodic measurement of blood pressure every week (1-3 times), creation of a weekly blood pressure diary, 24-hour blood pressure holter every six months, with stratification of patients under treatment according to the degree of AI found.

Secondary objectives:

* Evaluation of cardiological toxicity, through the execution of ECG, periodic echocardiography for the evaluation of the ejection fraction of the left ventricle, cardiac markers (troponin, CK-MB, pro-BNP)
* Assessment of the biochemical response, such as a 50% reduction in total PSA compared to baseline in patients receiving apalutamide;
* Evaluation of the change in blood chemistry parameters in the patient being treated with Apalutamide;
* Relationship between changes in blood chemistry parameters and time to the onset of metastases, assessed by PET PSMA or bone scan or CT scan;
* Relationship between changes in blood chemistry parameters and overall survival;
* Relationship between changes in blood chemistry parameters and occurrence of serious adverse events;
* Association between basophil counts and appearance of skin rash;
* Evaluation of drug interactions with Apalutamide.

Evaluation of Cardiotoxicity and Hypertension in Patients With Non Metastatic Castration Resistant Prostatic Carcinoma

Evaluation of arterial hypertension, by creation of a weekly blood pressure diary, 24-hour blood pressure holter every six months

Assessment of biochemical response, such as 50% change in total PSA from baseline in patients receiving apalutamide

Relationship between changes in blood chemistry parameters and time to onset of metastases, assessed by PET PSMA or bone scan or CT scan

Relationship between changes in blood chemistry parameters and overall survival

Relationship between changes in blood chemistry parameters and occurrence of serious adverse events

Association between basophil count and appearance of skin rash

Evaluation of drug interactions with Apalutamide

Nervous System Diseases

Peripheral Nervous System Diseases

Neuromuscular Diseases

Herbal and Botanical

All Drugs and Chemicals

Rosemary

Application of Rosemary oil (10%) to both hands and both feet once a day for 24 weeks

Rosemary oil application

Jan Vagedes, Dr.

Jan Vagedes, Dr

Chemotherapy can cause sensory disorders in the hands and feet called peripheral neuropathy. Typical symptoms are pain, loss of sensation, tingling, numbness, and gait disturbances, which worsen patients' quality of life and increase the risk of falls. Little is known about the effect of rosemary oil (applied to hands and feet) on the symptoms of neuropathy. The present study is a feasibility study to see if it is possible to conduct a clinical trial in patients diagnosed with cancer and receiving chemotherapy who report peripheral neuropathy and apply rosemary oil to their hands and feet.

Chemotherapy-induced peripheral neuropathy (CIPN) is one of the most common severe dose-limiting side effects that accompany treatment with different chemotherapeutic agents. Patients with CIPN often experience a reduction in quality of life and an increase in fall risk due to symptoms such as pain, sensory loss, paresthesia (tingling, numbness), and gait disturbances. Treatment of CIPN is based on pharmacotherapy, which may in turn cause side effects such as nausea, dizziness, fatigue and others. In addition, various approaches from integrative medicine are used, e.g. acupuncture, touch therapies, mind-body medicine, dietary supplements, and aromatherapy. Little is known about the effect of rosemary oil, applied to hands and feet, on CIPN. The present study is a feasibility study to determine the feasibility of a future clinical trial to investigate the efficacy of topical application of rosemary oil in cancer patients undergoing chemotherapy who develop CIPN.

Efficacy of External Application of Rosemary Oil in Patients With Chemotherapy-Induced Peripheral Neuropathy: a Feasibility Study

Efficacy of External Application of Rosemary Oil in Patients With Chemotherapy-Induced Peripheral Neuropathy - a Monocentre, Single-arm Non-controlled Feasibility Study to Assess the Feasibility of Evaluating Topical Applications in CIPN

Deidentified individual participant data will be made available, in addition to study protocol and informed consent form.

Participation rate in relation to all eligible patients and the reasons for non-participation. Reasons for refusal to participate in the study will be recorded.

The rate of fully completed EORTC QLQ-CIPN20 questionnaires in relation to incomplete questionnaires and reasons for missing data. EORTC QLQ-CIPN20 is used to measure the severity of CIPN pain and functional symptoms. It includes 20 items in three subscales to evaluate sensory (9 items), autonomic (3 items) and motor (8 items) symptoms and function. Each item is rated on a four-point Likert scale from 1 (not at all) to 4 (very much). Scores are summed up to a total score, which is linearly converted to a scale of 0-100 (a high score means more symptoms and pain).

Efficacy of rosemary oil in order to obtain a basis for a sample size calculation in a follow-up study. Effect of rosemary oil application will be measured using the EORTC QLQ-CIPN20 questionnaire. EORTC QLQ-CIPN20 is used to measure the severity of CIPN pain and functional symptoms. It includes 20 items in three subscales to evaluate sensory (9 items), autonomic (3 items) and motor (8 items) symptoms and function. Each item is rated on a four-point Likert scale from 1 (not at all) to 4 (very much). Scores are summed up to a total score, which is linearly converted to a scale of 0-100 (a high score means more symptoms and pain).

ARCIM Institute Academic Research in Complementary and Integrative Medicine

Central Nervous System Depressants

Anesthetics

Anabolic Androgenic Steroids

Prehabilitation arm group will receive preoperative intervention which includes exercise training, nutritional therapy and anxiety reducing techniques, aimed at preventing or attenuating surgery-driven functional decline.

Standard care treatment. Application of ERAS pathways (Enhanced Recovery After Surgery)

A tailored intervention will be prescribed if specific physical, nutritional or psychological impairments will be identified during the assessment phase. Based on the data obtained during the multimodal assessment, different domains and levels of care will be prescribed, focusing on exercise training, and/or nutrition optimization, and/or distress-coping techniques. Different combinations of three domains will be utilized to maximize their synergistic anabolic effect.

The duration of program will be set at 4 weeks. All activities will be performed in dedicated suites at each site, under supervision of qualified health professionals.

Multimodal prehabilitation Program

Luigi Beretta, Prof

Turi Stefano, MD

Gabriele Finco, MD

Giovanni Landoni, Prof

Stefano Turi, MD

The importance of postoperative rehabilitation on physical performance and recovery is well-recognized. However, the preoperative period constitutes a unique opportunity to address comorbidities and modifiable risk factors, improve functional capacity and address deficiencies in physiologic reserve, which might otherwise preclude surgery or significantly impede recovery.

Therefore, the aim of this study is to evaluate the efficacy of a multimodal program of prehabilitation in patients undergoing major oncological gastrointestinal surgery. The hypothesis is that severe post-operative complications within 30 days will be reduced in the treatment group compared to the control group.

This is a 2-arm randomized multicentric controlled trial to test the efficacy of a personalized, multidisciplinary, preoperative conditioning program to reduce severe complications and facilitate recovery in patients undergoing major oncological gastrointestinal surgery.

400 patients will be randomized (ratio 1:1) and allocated either to the intervention group (Prehabilitation), or to the control group (which will be treated according to usual standard of care within Enhanced Recovery After Surgery (ERAS) pathways).

Multimodal prehabilitation is a preoperative intervention which includes exercise training, nutritional therapy and anxiety reducing techniques, aimed at preventing or attenuating surgery-driven functional decline.

The primary objective is to evaluate the effect of a multimodal program of prehabilitation on postoperative severe complications.

Secondary outcomes include time to functional recovery, length of hospital stay, complication severity, proportion of patients returning to preoperative functional walking capacity and self-reported activity status and generic health related quality of life at 30 days after surgery.

Included patients will be randomized and allocated either to the intervention group, which will receive 4 weeks of prehabilitation, or to the control group, which will receive no prehabilitation. All patients will be reassessed the day before surgery, 30 days and 3 months after surgery.

Patients enrolled in treatment group will not receive any additional medication but only a multimodal program to optimize their preoperative functional capacity.

Within 30 days prior to scheduled surgery, participants of both groups will undergo a specialized multidisciplinary assessment with a physician, a certified physiotherapist, registered dietitian and psychology trained personnel. All tests will be performed following international guidelines and standardized verbal instructions. A tailored intervention will be prescribed if specific physical, nutritional or psychological impairments will be identified during the assessment phase. Based on the data obtained during the multimodal assessment, different domains and levels of care will be prescribed, focusing on exercise training, and/or nutrition optimization, and/or distress-coping techniques. Different combinations of three domains will be utilized to maximize their synergistic anabolic effect.

Statistical analysis will be performed according to study sites, type of surgery (esophageal, gastric, colonic, rectal) and neoadjuvant treatment.

Prehabilitation in Oncological Patients Undergoing Major Gastrointestinal Surgery (PROGRESS)

Evaluation of a Multimodal Program of Prehabilitation in Oncological Patients Undergoing Major Gastrointestinal Surgery Within an ERAS Pathway.

Reduction of incidence of postoperative complications.

Reduction of lenght of hospital stay in treatment group

Improving return to basal functional preoperative capacity

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
COVID-19 Infection in Cancer Pantients	NCT04569292	Covid19	No intervention...	-	Ospedale Andrea Tortora di Pagani
Evaluation of Cardiotoxicity and Hypertension in Patients With Non Metastatic Castration Resistant Prostatic Carcinoma	NCT04567875	Castration-resi...	No Intervention...	-	Ospedale Andrea Tortora di Pagani
COVID-19 Infection in Cancer Pantients	NCT04569292	Covid19	No intervention...	-	Ospedale Andrea Tortora di Pagani
Efficacy of External Application of Rosemary Oil in Patients With Chemotherapy-Induced Peripheral Neuropathy: a Feasibility Study	NCT05855044	Chemotherapy-in...	Rosemary oil ap...	18 Years -	ARCIM Institute Academic Research in Complementary and Integrative Medicine
Evaluation of Cardiotoxicity and Hypertension in Patients With Non Metastatic Castration Resistant Prostatic Carcinoma	NCT04567875	Castration-resi...	No Intervention...	-	Ospedale Andrea Tortora di Pagani
Prehabilitation in Oncological Patients Undergoing Major Gastrointestinal Surgery (PROGRESS)	NCT06404489	Oncological Pat... Major Surgery	Multimodal preh...	18 Years -	Università Vita-Salute San Raffaele
Evaluation of Cardiotoxicity and Hypertension in Patients With Non Metastatic Castration Resistant Prostatic Carcinoma	NCT04567875	Castration-resi...	No Intervention...	-	Ospedale Andrea Tortora di Pagani
Efficacy of External Application of Rosemary Oil in Patients With Chemotherapy-Induced Peripheral Neuropathy: a Feasibility Study	NCT05855044	Chemotherapy-in...	Rosemary oil ap...	18 Years -	ARCIM Institute Academic Research in Complementary and Integrative Medicine
Prehabilitation in Oncological Patients Undergoing Major Gastrointestinal Surgery (PROGRESS)	NCT06404489	Oncological Pat... Major Surgery	Multimodal preh...	18 Years -	Università Vita-Salute San Raffaele

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