Heart and Blood Diseases

All Conditions

Blood and Lymph Conditions

Thrombosis

Thrombophilia

Hematologic Diseases

10,000 highly controlled blood donors in the age range 30-70 years

A sample of 1,000 tumor cases have been identified so far and samples from these participants will be analyzed compared to 1,000 controls from randomly extracted from the Moli-sani cohort (parent cohort).

4,000 Patients with breast, lung, and gastrointestinal tumors.

Anna Falanga, MD

Andrea D'Alessio, MD

Sara Cecchini, MD

Fausto Fausto, MD

Mara Ghilardi, MD

Armando Santoro, MD

Giovanna Masci, MD

Roberto Labianca, MD

Carlo Tondini, MD

Carmen J. Tartari, PhD

Filippo De Braud, MD

Luigi Celio, MD

Giampietro Gasparini, MD

Roberta Sarmiento, MD

Mauro Minelli, MD

There is a complex, mutual relationship between cancer and thrombosis. Indeed, the tumor has the capacity to activate the hemostatic system and this leads to an increased thrombotic risk in cancer patients. Even in the absence of clinical manifestations, cancer patients are commonly characterized by hemostatic abnormalities, recognized only by laboratory testing, which define the 'hypercoagulable state'. Of interest, hypercoagulation has been repeatedly reported to be associated with tumor progression and poor prognosis in various carcinomas. On the other hand, thrombotic event can represent the first signal of the presence of an occult tumor. These findings suggest that the coagulant pathway might play a role in the preclinical phase of cancer. The investigators hypothesize that a persistent, subclinical activation of the hemostatic system in an otherwise healthy subject, may predispose not only to thrombosis, but also to tumor formation and spreading. A major problem in primary cancer prevention is the lack of effective predictive markers of the disease. The HYPERCAN is an ongoing prospective Italian multicenter study organized around two tightly-interconnected research programs aiming to: 1_the assessment of thrombotic markers as a tool for cancer risk prediction in two large populations of healthy subjects, i.e. a group of healthy blood donors of Bergamo and Milano Provinces and a subgroup of Moli-sani subjects of the Molise region; and 2_ the evaluation whether thrombotic markers and/or the occurrence of overt thrombosis (or disseminated intravascular coagulation) may be prognostic of cancer disease outcomes (i.e. overall survival, progression free survival in metastatic cancer, disease free survival in limited disease) in cancer patients with different types of solid tumors (i.e. breast, lung and gastrointestinal cancers).

Therefore, the assessment of cancer risk occurrence in healthy individuals might be useful for anticipation of cancer diagnosis. In addition, the results of this study might help to evaluate whether thrombotic markers may be prognostic of cancer outcomes independently of the disease extension.

Hypercoagulation Screening in Cancer

Hypercoagulation Screening as Innovative Tool for Risk Assessment, Early Diagnosis and Prognosis in Cancer

Samples collected from identified participants with cancer diagnosis will be assessed to determine the hypercoagulation profile (ratio for laboratory analysis cancer case : healthy control from same cohort = 1:3, matched for age and gender)

Identification of cancer patients with evidence of thrombotic event derived from review of clinical records.

Identification of cancer patients with evidence of cancer progression derived from review of clinical records.

Associazione Italiana per la Ricerca sul Cancro

Istituto Neurologico Mediterraneo Neuromed S. R. L

Fondazione Humanitas per la Ricerca

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

ASL Roma 1

Istituti Ospedalieri Bergamaschi Srl

ASST Bergamo Ovest

Istituti Tumori Giovanni Paolo II

A.O. Ospedale Papa Giovanni XXIII

Director of the Division of Immunohematology and Transfusion Medicine

Neoplasms

Digestive System Diseases

Rare Diseases

Behaviors and Mental Disorders

Esophageal Neoplasms

Esophageal Cancer

Quality of Life

Patients allocated to usual care control will receive the standard patient care program as provided by the department of surgical gastroenterology, Rigshospitalet

Patients allocated to this group will receive usual care plus a supervised aerobic and resistance exercise program at CFAS' facilities consisting of 2 weekly sessions of approximately 60 minutes.

Supervised aerobic and resistance exercise program consisting of 2 weekly sessions of approximately 60 minutes. Patients will perform a test of maximum cardio-respiratory (Watt-max test) and muscle strength (1 repetition maximum \[1-RM\] test) capacity. Using the patient's individual capacity score (Watt-max and 1RM), a personalized exercise program will be prescribed. After a light warm-up, patients will perform 20-30 min of aerobic interval training of stationary bicycle. Resistance training comprises 4 exercises for the major muscle groups: chest press, leg press, lateral pull, and knee extension with 3-4 sets of 8 to 15 repetitions. Each session will be supervised by trained instructors to ensure proper technique, and progression in training load.

Aerobic and Resistance Exercise Training

Jesper F Christensen, PhD

Background:

For patients diagnosed with operable cancer of the gastro-esophageal junction (GEJ), the perioperative course of therapy is associated with severe deconditioning which includes weight loss and poor physical function, which are strong predictor of post-surgical complication and survival . A strong rationale exists to explore how to develop supportive interventions aimed at maintaining/improving muscle function (lean body mass and muscle strength) during the pre-surgical phase.

This study explores the safety, feasibility and efficacy of structured pre- and post-operative exercise training in patient undergoing surgery for cancer of the gastro-esophageal junction.

Subjects: Patients with histologically verified, resectable adenocarcinoma of the GEJ scheduled for treatment af Rigshospitalet, Copenhagen, Denmark.

Methods: In a case-control design, patients will be allocated to either an exercise training intervention group, or a usual-care observational group, based on geographical location. Forty patients will be included in this case-control study and allocated by geographical region as follows; 20 training intervention-cases living in the greater Copenhagen area, and 20 observational control subjects living outside the greater Copenhagen area.

All patients will undergo a total of 5 assessments during the perioperative trajectory; twice prior to surgery (baseline and pre-surgery test), three post-surgery (2 week post- and 15 weeks post-surgery, and at 1-year follow-up).

Assessments include measures of body composition by DXA scan and bioelectrical impedance analysis: systemic inflammation in fasting blood sample; quality of life by self-report questionnaires; physical function by handgrip strength and sit-to-stand test.

As optional procedures, we will collect biological tissue from tumor, muscle and fat biopsies and a 10 ml blood sample at baseline and pre-surgery test only. Also, we will collect blood samples before, during and after an acute exercise bout exercise in order to explore the acute systemic changes in exercise-regulated biomarkers.

BACKGROUND AND RATIONALE Patients diagnosed with operable cancer in upper gastro-intestinal (GI) tract undergo serious therapeutic procedures including invasive surgery combined with chemo- or chemo-radio therapy before (neo-adjuvant) and/or after (adjuvant) surgery. Despite recent advances, especially in surgical techniques and patient care follow-up, the population is faced with one of the worst prognosis for patients with operable staged disease, with a 5-year relative survival of 35-40%. The only possibility of long-term survival is positive surgical outcome, which includes the surgical principle of performing wide clearance, achieving a negative margin (R0 resection), and performing a radical lymphadenectomy. To this end, considerable efforts have been made in recent years optimizing the perioperative period in order to provide the patients and the surgeons with the best possible chances of achieving this surgical outcome.

Adenocarcinoma of the gastro-esophageal junction (GEJ) has increased in incidence over the last quarter century. For patients presenting with localized disease, advances in standards of care have emerged in recent years which have improved disease management. Firstly, comprehensive staging with Computed Tomography (CT), endoscopic ultrasound, diagnostic laparoscopy and fluoro deoxy glucose position emission tomography (18FDG-PET) permits exclusion of patients for curative therapy who might previously have been scheduled for resection. Secondly, evidence supports that esophagectomy is performed in high-volume hospitals by high-volume surgeons. Finally, standard neoadjuvant and adjuvant therapies are performed in most centers for patients with localized esophageal adenocarcinoma which has improved both short- and long-term cancer outcomes.

Prognostic role of Muscle Function in upper GI cancer For all upper GI cancers, including GEJ, the perioperative course of therapy is associated with severe deconditioning which includes weight loss and poor physical function. Over the last decade, strong observational evidence has emerged supporting that poor pre-surgical muscle function, defined as either low muscle mass/area (sarcopenia) or low functional strength, is a strong independent predictor of post-surgical outcomes including mortality, surgical complications and chemotherapy dose-reduction. Importantly, strong evidence across different malignancies has shown that the prognostic value of muscle function is independent from body mass, and may actually be under-reported due to sarcopenic obesity. Thus, current available therapeutic countermeasures in clinical practice, which exclusively involve nutritional interventions, may have limited potential for ameliorating the progressive muscle dysfunction during perioperative treatment for GEJ cancer.

Exercise-Oncology and Upper GI cancer Epidemiological evidence across both heterogeneous and homogeneous groups of cancer patients have shown that low physical activity level after diagnosis is associated with poor disease-specific and overall survival. Despite a general emerging interest, limited attention has been dedicated to the exploration of safety, feasibility and efficacy of structured exercise interventions in patients with upper GI cancer. However, data from recent studies suggests an unmet potential of physical exercise in these patients, with particular emphasis on the pre-surgical period.

STUDY OBJECTIVES Primary Objective

• To explore safety and feasibility of structured exercise in the pre- and post-operative phases among patients undergoing treatment for operable GEJ cancer

Secondary objectives:

* To explore the effect of perioperative exercise training on clinical (e.g. clindo-davien score, pneumonia, anastomotic leakage) physiological (e.g. muscle strength, physical function) and psycho-social (e.g. fatigue, emotional well-being, anxiety) endpoints relative to usual care.
* To explore the prognostic role of pathophysiological profile (physical function, pulmonary function, and body-composition) on post-surgical complications

Explorative objectives:

* To explore molecular adaptations of metabolism and physiology in tumor, muscle and fat samples taken before and after neo-adjuvant chemotherapy in the pre-operative phase in (a sub-group of) patients allocated to exercise training or usual care
* To explore the acute response in immune cells, hormones and cytokines in blood samples taken before, during and after a single exercise session
* Collection of blood and tissue samples for storage in bio-bank for future research.

STUDY DESIGN This prospective, regional-based case-controlled feasibility trial will include in a minimum of 40 patients, including 20 training intervention-cases who are residents in greater Copenhagen Area, and 20 usual care controls living outside the greater Copenhagen area.

Recruitment: Patients will be recruited from the department of surgical gastroenterology, Rigshospitalet, following multidisciplinary medical conference. The responsible physicians will provide oral information and present patients with the written information of the study.

Patients who are willing to participate will sign informed consent, before any study related procedures are performed. After signing informed consent, patients are scheduled for baseline assessment and will be allocated based on geographical location (home-town municipality), to one of two experimental arms:

I) Patient residing OUTSIDE the Copenhagen area, will be allocated to a usual care observation group, which includes nurse-based follow up procedures and information on life style factors (diet, smoking cessation, alcohol, and physical activity).

II) Patients residing WITHIN the Copenhagen area, will be allocated to usual care plus hospital-based aerobic and resistance training at Centre for Physical Activity Research, Rigshospitalet

Procedures will involve assessment-measures conducted a total of 5 times during the study period: twice prior to surgery (baseline and pre-surgery test), twice post-surgery (3 week post- and 15 weeks post-surgery) and at 1-year follow-up.

The following assessments will be performed:

1. Body composition by Bioelectrical Impedance
2. Fasting blood sample for analyses of plasma biochemistry (cholesterol, triglycerides, inflammatory markers, HbA1C)
3. Health related Quality of Life questionnaires
4. Physical function: Handgrip strength and sit-to-stand test.
5. Forced Expiration Volume in 1 second (FEV1)
6. Biological tissue sampling (OPTIONAL): tumor, muscle and fat biopsies and blood samples - only baseline and pre-surgery.
7. Acute Exercise Response (OPTIONAL); blood samples taken before and after a single exercise session.

ANALYTIC PLAN As a feasibility study, this trial is explorative in nature and performed primarily in order to determine whether it is appropriate to advance with a larger scaled randomized controlled trial.

Primary aim

Safety and feasibility of perioperative exercise training in patients with operable GEJ cancer

In order to evaluate the safety and feasibility of the pre- and post-surgical exercise in patients with operable cancer of the gastro-esophageal junction, incidence of serious adverse events in both groups will be determined, and adherence to exercise, assessed by number of training sessions completed in the training group.

Secondary aims

Efficacy of perioperative exercise training to improve clinical, physiological and psycho-social outcomes in patients operable GEJ cancer.

In order to determine whether exercise training has the capacity to improve study outcomes intragroup changes, and inter-group differences for study outcomes will be calculated. For this purpose a random effect analysis will be performed with repeated measures and study outcomes as dependent variables, with the covariates "group", "time" and their interaction as fixed effects, and a random effect of "patient", adjusted for baseline-score, chemotherapy regimen, and surgical procedure (conventional vs laparoscopic).

Prognostic role of pathophysiological profile in patients with operable GEJ cancer

In order to explore the prognostic role of the study assessment outcomes on key clinical endpoints: post-surgical complications, hospital stay duration and disease free and overall mortality risk over the first years after surgery, by a general linear regression models with clinical endpoints being the dependent variable, and study assessment outcomes as the independent variables adjusted for baseline-score, chemotherapy regimen, and surgical procedure (conventional vs laparoscopic). For each variable (physical function, pulmonary function, and body-composition), the predictive value of: I) the diagnostic level (prior to neo-adjuvant therapy), II) the pre-surgical level (after neo-adjuvant treatment) and III) the change score from diagnostic to pre-surgical level (during neo-adjuvant therapy) will be determined.

Dropouts and Missing Observations Patients who wish to drop-out of the study during the intervention-periods will be offered to remain in the study with regard to test-assessments. Patients who drop out prior to 'visit 2' will be replaced. For between-group analyses, all drop-outs and missing observations will be handled by the "missing at random" principle.

ETHICAL CONSIDERATIONS This study will be conducted in accordance with the regional ethical committee and the Declaration of Helsinki (1964) with its subsequent revisions. The protocol and any substantial amendments, the study patient information and consent form, as well as other relevant or requested material have been approved by the local ethics committee (Videnskabsetisk Komite) for the Capital Region of Denmark (Protocol number: H-15014904) and is reported to the Danish Data Protection Agency (Datatilsynet: RH-2016-33, I-Suite nr.: 04396) through Rigshospitalet/Capital Region of Denmark (j.nr. 2012-58-0004).

The project is expected to cause limited risks, side effects and discomfort. All procedures will be performed by experienced physicians, therapists and physiologists with relevant safety, and patients will not experience any kind of delays or complications related to treatment or control process due to participation in the project. Patients may at any time, and without justification, retract their consent.

PeRioperative Study of Exercise Training in Patients With Operable Cancer of the Gastroesophageal Junction

PeRioperative Study of Exercise Training - a None-randomized Feasibility Study: Usual Care Observation vs Exercise Training Intervention in Patients With Operable Cancer of the Gastroesophageal Junction

For the pre-surgical period (at baseline- and during surgery), we will ask for patients' separate consent to do a gastroscopy with sampling of a tumor biopsy; a muscle biopsy from m. vastus lateralis, fat biopsy from subcutaneous abdominal adipose tissue; and a blood sample, all of which will be collected during full anesthesia. A gastroscopy will be performed and endoluminal tumor biopsies will be collected under full anesthesia in patients who have given informed consent, after the diagnostic laparoscopy is completed. Muscle biopsies of approx. 200 mg per biopsy, will be collected from m. vastus lateralis using the Bergstrom-technique, and fat biopsies of approx. 200 mg per biopsy will be collected from the subcutaneous adipose tissue in the abdomen. Standard procedure requires the resection specimen to be dissected and cut open to determine lymph node classification and resection margins.

Recording of adverse events will be separated into two procedures: recordings during trial visits and recordings during exercise sessions.

AE/SAE recording during trial assessment visits This procedure will concern any AE/SAE which can be attributed to study-related assessment procedures during the trial visits, i.e. discomfort during physical tests or blood sampling, which will be recorded immediately during the visit and recorded for the given visit. Also, for each trial visit we will collect patients' self-report of AE/SAEs, which may have occurred during the period since the last trial visit without our knowledge.

AE/SAE recording during exercise sessions For every exercise session, a trained instructor will supervise the exercise program including recording of AE/SAEs during these session

Proportion of exercise sessions completed.

Body fat percentage is assessed measuring bioelectrical impedance in the body using a state-of-the-art Bioelectrical Impedance Analyzer (Tanita MC-780 MA, Tokyo, Japan). The degree of difficulty with which electricity passes through a substance is known as the electrical resistance, and the percentage of fat and other body constituents can be inferred from measurements of this resistance. The analyzer measures body composition using a constant current source with a high frequency current (50kHz, 90µA) with 8 electrodes positioned so that electric current is supplied from the electrodes on the tips of the toes of both feet, and voltage is measured on the heel of both feet. The current flows into the upper limbs or lower limbs, depending on the body part(s) to be measured. Patients with pacemakers or other electrical implants will not undergo this measure due to safety specifications.

Lean mass is assessed measuring bioelectrical impedance in the body using a state-of-the-art Bioelectrical Impedance Analyzer (Tanita MC-780 MA, Tokyo, Japan). The degree of difficulty with which electricity passes through a substance is known as the electrical resistance, and the percentage of fat and other body constituents can be inferred from measurements of this resistance. The analyzer measures body composition using a constant current source with a high frequency current (50kHz, 90µA) with 8 electrodes positioned so that electric current is supplied from the electrodes on the tips of the toes of both feet, and voltage is measured on the heel of both feet. The current flows into the upper limbs or lower limbs, depending on the body part(s) to be measured. Patients with pacemakers or other electrical implants will not undergo this measure due to safety specifications.

Body fat mass is assessed measuring bioelectrical impedance in the body using a state-of-the-art Bioelectrical Impedance Analyzer (Tanita MC-780 MA, Tokyo, Japan). The degree of difficulty with which electricity passes through a substance is known as the electrical resistance, and the percentage of fat and other body constituents can be inferred from measurements of this resistance. The analyzer measures body composition using a constant current source with a high frequency current (50kHz, 90µA) with 8 electrodes positioned so that electric current is supplied from the electrodes on the tips of the toes of both feet, and voltage is measured on the heel of both feet. The current flows into the upper limbs or lower limbs, depending on the body part(s) to be measured. Patients with pacemakers or other electrical implants will not undergo this measure due to safety specifications.

Concentrations of total cholesterol will be measured in fasting blood samples by standard laboratory methods.

Concentrations of LDL-cholesterol will be measured in fasting blood samples by standard laboratory methods.

Concentrations of HDL-cholesterol will be measured in fasting blood samples by standard laboratory methods.

Concentrations of triglyceride will be measured in fasting blood samples by standard laboratory methods.

HbA1C will be measured in fasting blood samples by standard laboratory methods.

Concentrations of TNFa will be measured in fasting blood samples by Enzyme-linked immunosorbent assay (ELISA) analyses.

Concentrations of IL-6 will be measured in fasting blood samples by Enzyme-linked immunosorbent assay (ELISA) analyses.

Concentrations of IL-8 will be measured in fasting blood samples by Enzyme-linked immunosorbent assay (ELISA) analyses.

Concentrations of IL-10 will be measured in fasting blood samples by Enzyme-linked immunosorbent assay (ELISA) analyses.

Patient reported quality of life is measured by Functional Assessment of Cancer Treatment (FACT)

Patient reported sleep quality is measured by the Pittsburgh Sleep Quality Index (PSQI) questionaire

Patient reported Anxiety and Depression is measured by the Hospital Anxiety and Depression Scale (HADS).

Patient reported physical activity is measured by the Internations Physical Activity Questionaire (IPAQ) - short form

Sit-to-stand test: Lower-body physical function is assessed by 30-second sit-to-stand test. Using a chair fixed to the ground with a seat 45 cm above the ground subjects will be instructed to sit in the middle of the chair, back straight, arms crossed over their chest, feet flat on the floor. Correct technique will be demonstrated first, and subjects will practice for two-three repetitions. On the signal "go" subjects will be asked to stand then return to the seated position, as many times as possible in 30 seconds.

Handgrip strength is assessed by hand-held dynamometer. Grip strength is measured in a seated position with the elbow flexed at 90°, with three attempts performed for each hand. During testing, the participant will be encouraged to exhibit the best possible force, and the best measure in the strongest hand will be used as test score.

FEV1 is evaluated by validated assessment measure of pulmonary function. The patient is instructed to make a complete inspiration and then inserts the mouthpiece into the mouth, closes the lips around it but with the jaws apart, and blows out through the mouth as hard and as completely as possible with strong verbal encouragement given throughout this sequence. The FEV1 score is the fraction of the total volume which is expired in the first second

Jesper Frank Christensen, PhD

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Central Nervous System Depressants

All Drugs and Chemicals

Analgesics

Anesthetics

Morphine

Analgesics, Opioid

Tramadol

Narcotics

30 patients who received intravenous morphine intraoperatively, without regional block application

30 patients who had preoperative esp block but did not use morphine during or after surgery

30 patients who received multimodal analgesia methods other than ESP block or IV morphine

PREOPERATIVE ANALGESIA: None

INTRAOPERATİVE ANALGESIA:

1. Paracetamol 1000 mg IV
2. Morphine 0,1 mg/kg IV

POSTOPERATIVE ANALGESIA IV Morphine Patient-Controlled Analgesia (PCA) Rescue analgesic: IV paracetamol

PREOPERATIVE ANALGESIA:

Ultrasonography (USG) guided ESP block:T4 spinal level, %0,25 concentration 20 ml, single injection

INTRAOPERATİVE ANALGESIA:

1. Paracetamol 1000 mg IV
2. dexketoprofen 50 mg IV

POSTOPERATIVE ANALGESIA IV PCA with tramadol Rescue analgesic: IV paracetamol

Erector Spinae Block

PREOPERATIVE ANALGESIA: none

INTRAOPERATİVE ANALGESIA:

1. Paracetamol 1000 mg IV
2. Dexketoprofen 50 mg IV

POSTOPERATIVE ANALGESIA IV PCA with tramadol Rescue analgesic: IV paracetamol

Control

hazal ekin güran aytug, resident

Worldwide, breast cancer is the most common cancer among women, and its incidence and mortality rates are expected to increase significantly in the next years. It remains a major health problem. There is a vast area on breast cancer and immunity that still needs to be researched. Do anesthetic techniques and medication preferences effect immune responses? If so how they effect breast cancer outcomes is unclear.

On this trial, the investigators are searching anesthetic techniques affect on inflammatory and immune responses.

Breast cancer is the most frequently encountered surgery among all cancer surgeries. Although it is a well known procedure for anesthesiologists, it is still unclear whether anesthesiology effects immune responses. Cancer therapies often use immune therapies such as Bevacizumab (a monoclonal antibody which targets Vascular Endothelial Growth Factor), Trastuzumab(a monoclonal antibody for Herceptin (HER2/Neu) mutation) how anesthetics effect VEGF stays unclear.

Opioids are commonly used to provide analgesia for cancer pain, and functional opioid receptors have been identified on natural killer (NK) cells, the lymphocytes responsible for surveillance and elimination of cancer cells.\[4\] Anesthesiologists have well founded concerns about using morphine during cancer surgeries.

Regional anesthetic techniques commonly used on cancer surgeries.The activation of sensory neurons during pain enhances tumor progression and metastatic potential. Regional anesthesia blocks somatic nociception and inhibits sympathetic preganglionic outflow (functional sympathectomy) during surgery. Moreover regional anesthesia, by blocking sympathetic nervous system output, induces a prevalence of parasympathetic tone. Local anesthetics can also modulate autonomic receptors. For these reasons, more studies are needed to investigate the action of regional anesthetic neuromodulation on cancer progression.\[11\]

The Erector Spinae Plane Block (ESP block) is most often performed on thoracic paraspinal levels, causes sympathetic blockage. Sympathetic block has been studied on central neuraxial blocks but the sympathetic block caused by the ESP block and immune responses remain unclear.

Sympathetic block inhibits hyperbolic immune responses after surgery, therefore enhances postoperative rate of acceleration on cytokine levels. The investigators propose that ESP block improves immune responses and improved immune responses have better clinical outcomes for patients with breast cancer. Improved immune responses decrease length of stay (LOS), enhance postoperative recovery, analgesia and quality of life. Therefore allows better patient experience about procedures.

The investigators will take 90 patients who will undergo a breast cancer operation and compare vitals (heart rate, blood pressure, oxygen saturation), Numeric Rating Scales (NRS), Vascular Endothelial Growth Factor (VEGF) responses, systemic immune inflammatory indexes, cortisol levels, CRP and Procalcitonin levels between three groups; opioid analgesia group(group M), ESP block group(group E), non-opioid non-ESP group (group P).

The investigators' main focus is immune alterations after anesthesia techniques. Anesthesiologist keep track of pain scores after surgery. this trials secondary outcome focuses on pain management after surgery.

Metabolomic Profiling of Erector Spinae Plane Block* for Breast Cancer Surgery

Metabolomic Profiling of Erector Spinae Plane Block for Breast Cancer Surgery

The investigators will share Study Protocol, Statistical Analysis Plan (SAP), Informed Consent Form (ICF), Clinical Study Report

Metabolomic profiling of 3 groups will be performed with liquid chromatography mass spectrometrt (LCMS) and Quadrupole time-of-flight (Q-TOF).

The investigators will measure VEGF preoperative(baseline), postoperative hour 24 from blood analysis.

Normal ranges of serum VEGF were 62-707 pg/ml.

The investigators will measure cortisol preoperative(baseline),postoperative hour 1, postoperative hour 24 from blood analysis.

Serum cortisol normal range for adults 8 am to 4pm: 5-25 mcg/dL

The investigators will measure CRP preoperative(baseline), postoperative hour 1, postoperative hour 24 from blood analysis.

CRP normal reading is less than 10mg/L.

The investigators will evaluate patients' pain score with numeric rating scale (NRS) postoperative hour 1, 2, 12, 24 and compare NRS between the control group (group c), the ESP block group (group E) and intravenous morphine group (group M)

The investigators will compare NRS between two groups at postoperative hour 1, 2, 12, 24.

The most common form of NRS is a horizontal line with an eleven point numeric range, from 0 (patient with no pain) to 10 (patient with the worst pain possible).

The investigators will record total opioid consumption via Patient-Controlled Analgesia devices.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Hypercoagulation Screening in Cancer	NCT02622815	Healthy Blood D... Moli-sani Subje... Cancer Patients		-	A.O. Ospedale Papa Giovanni XXIII
PeRioperative Study of Exercise Training in Patients With Operable Cancer of the Gastroesophageal Junction	NCT02722785	Gastro-esophage...	Aerobic and Res...	18 Years - 80 Years	Rigshospitalet, Denmark
Metabolomic Profiling of Erector Spinae Plane Block* for Breast Cancer Surgery	NCT04689945	Breast Cancer	Morphine Erector Spinae ... Control	18 Years - 65 Years	Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
Hypercoagulation Screening in Cancer	NCT02622815	Healthy Blood D... Moli-sani Subje... Cancer Patients		-	A.O. Ospedale Papa Giovanni XXIII
Metabolomic Profiling of Erector Spinae Plane Block* for Breast Cancer Surgery	NCT04689945	Breast Cancer	Morphine Erector Spinae ... Control	18 Years - 65 Years	Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

Spots Global Cancer Trial Database for cancer prognosis