Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Anti-Arrhythmia Agents

Antihypertensive Agents

Vasodilator Agents

All Drugs and Chemicals

Anti-Inflammatory Agents

Antirheumatic Agents

Analgesics

Propranolol

Adrenergic beta-Antagonists

Adrenergic Agents

Adrenergic Antagonists

Etodolac

Cyclooxygenase 2 Inhibitors

Neurotransmitter Agents

Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic

Cyclooxygenase Inhibitors

Enzyme Inhibitors

Both study medications will be given orally for an intervention phase of 35 days as follows. Etodolac:400mg PO bid for the entire intervention period,Propranolol:20 mg PO bid for 5 preoperative days, 80 mg PO bid on the day of surgery and the following morning, 40 mg PO bid for following 6.5 days, and 20 mg PO bid for next 22 days.

Same schedule as in the active comparator arm

Propranolol and etodolac

Placebo

Oded Zmora, MD

Talia Golan, MD

Ido Nachmany, MD

In Israel, of the \~1000 patients diagnosed annually with pancreatic cancer (PC), approximately 250 (25 percent) will be eligible for curative surgery, of which 80 percent will succumb to post-surgical metastatic disease. A reduction in post-surgical metastatic disease will save dozens of patients in Israel annually, and tens-of thousands-around the world. The short perioperative period (days to weeks around surgery) is characterized by stress-inflammatory responses, including catecholamines (CAs, e.g., adrenaline) and prostaglandins (PGs, e.g., prostaglandin-E2) release, and induce deleterious pro-metastatic effects. Animal studies implicated excess perioperative release of CAs and PGs in facilitating cancer progression by affecting the malignant tissue, its local environment, and anti-metastatic immune functions. Congruently, our animal studies indicate that combined use of the beta-adrenergic blocker, propranolol, and the prostaglandins inhibitor, etodolac - but neither drug separately - efficiently prevented post-operative metastatic development. We recently conducted two clinical trials in three medical centers in Israel, recruiting breast (n=38) and colorectal (n=34) cancer patients, assessing the safety and short-term efficacy of perioperative propranolol and etodolac treatment. Drugs were well tolerated, without severe adverse events. Importantly, molecular/biological analyses of the excised primary tumor indicated that drug treatment caused promising anti-metastatic transformations, as well as improvements in immune and inflammatory indices. These included (i) decreased tumor cell capacity to migrate, (ii) reduced pro-metastatic capacity of the malignant tissue, and (iii) improvement in immune infiltrating into the tumor (Paper published in Clinical Cancer Research, 2017). Herein, we propose to conduct a double-blind placebo-controlled two-arm Phase II clinical trial in 210 pancreatic cancer patients undergoing curative surgery in Israel. A perioperative 35-day drug treatment will be initiated 5 days before surgery. Primary outcomes will include (i) 1-year disease-free-survival (DFS), and 5-year overall survival (OS); and (ii) biological markers in blood samples, and in the excised tumor tissue. Secondary outcomes will include safety indices and psychological measures of depression, anxiety, distress, and fatigue.

Perioperative Intervention to Reduce Metastatic Processes in Pancreatic Cancer Patients Undergoing Curative Surgery

Perioperative Use of a Beta-adrenergic Blocker and a COX-2 Inhibitor in Patients Undergoing Surgery With Primary Pancreatic Cancer: Intervention Aiming to Reduce Pro-metastatic Processes

Data regrading post-surgical recurrence will be recorded at 1,3,6,12,18,24,36,48, and 60 following surgery

Epithelial-to-mesenchymal-transition ( EMT) status and natural-killer cell, macrophage, T-cell, and B-cell infiltration levels into tumor tissue (as assessed by messenger RNA profiling of tissue samples.

Cytokine levels in blood samples (interleukin-6, interleukin-10, C-reactive protein, interferon-gamma, and vascular endothelial growth factor and additional exploratory analysis of other cytokines)

According to the Clavien-Dindo classification system (7 grades of events depicting the severity of the event)

Assessed by changes on the brief symptom inventory 18 questionnaire (this questionnaire assess all three scales for depression, anxiety and global distress)

4 items related to fatigue in the 36 item short-form survey questionnaire.

Sheba Medical Center

Assaf-Harofeh Medical Center

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Carcinoma

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Fallopian Tube Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Gonadal Disorders

Fallopian Tube Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

Fallopian Tube Cancer

Participants will receive mind-body resilience training/MBRT, music therapy, propranolol and etodolac pre and post operatively. Postoperative Psychological Interventions may occur between POD 1-7 if needed.

Participants will receive usual care (study interventions not specifically recommended)

MBRT is a meditation technique used to achieve relaxation)

Mind-body resilience training

Music listening was found, in multiple trials, to significantly reduce self-reported anxiety, physiologic indicators of anxiety, and/or sedation requirements

Music therapy

Propranolol 20 mg PO BID (for 21 consecutive days), Propranolol 10mg PO BID (for 3 consecutive days POD 14-16)

Etodolac 400 mg PO BID (for 21 consecutive days)

Kara Long Roche, MD

Anoushka Afonso, MD

The purpose of this study is to see if propranolol and etodolac along with mind-body resilience training/MBRT and music therapy help participants who are experiencing physiological stress before, during, and after primary debulking surgery/PDS or IDS and also if it's better than the standard-of-care approach (no intervention for reducing stress).

A Study Comparing Perioperative Stress Reduction vs. Standard of Care in Ovarian Cancer (PRESERVE)

Perioperative Stress Reduction in Ovarian Cancer (PRESERVE Trial)-A Prospective Randomized Pilot Study

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

The primary objective of this study is to investigate the feasibility of implementing a multimodal PSRB in women undergoing PDS or IDS for advanced EOC. This will be measured as number of patients successfully completing over 80% of the bundled interventions, including a preoperative integrative medicine session, postoperative integrative medicine session, total intravenous anesthesia on day of surgery, and perioperative beta blocker and COX2 inhibitor

Memorial Sloan Kettering Cancer Center

Symptoms and General Pathology

Recurrence

Colorectal Neoplasms

Neoplasm Metastasis

Intestinal Neoplasms

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Herbal and Botanical

Cola

Both study medications will be given orally for an intervention phase of 20 days as follows. Etodolac:400mg PO bid for the entire intervention period, Propranolol (slow release): 20 mg PO b.i.d. for 5 preoperative days; 80 mg PO b.i.d. on the day of surgery; 40 mg PO b.i.d. for the first post-operative week and 20 mg PO b.i.d. for the second post-operative week.

Doron Kopelman, MD

Simon D Duek, MD

Nir Wasserberg, MD

Hagit Tulchinsky, MD

Mordechai Gutman, MD

The short perioperative period (days to weeks around surgery) is characterized by stress-inflammatory responses, including catecholamines (CAs, e.g., adrenaline) and prostaglandins (PGs, e.g., prostaglandin-E2) release, and induce deleterious pro-metastatic effects. Animal studies implicated excess perioperative release of CAs and PGs in facilitating cancer progression by affecting the malignant tissue, its local environment, and anti-metastatic immune functions. Congruently, animal studies conducted by the investigators indicate that combined use of the beta-adrenergic blocker, propranolol, and the prostaglandins inhibitor, etodolac - but neither drug separately - efficiently prevented post-operative metastatic development. Two recently conducted clinical trials, conducted by the investigators, in three medical centers in Israel, recruiting breast (n=38) and colorectal (n=34) cancer patients, assessing the safety and short-term efficacy of perioperative propranolol and etodolac treatment. Drugs were well tolerated, without severe adverse events. Importantly, molecular/biological analyses of the excised primary tumor indicated that drug treatment caused promising anti-metastatic transformations, as well as improvements in immune and inflammatory indices. These included (i) decreased tumor cell capacity to migrate, (ii) reduced pro-metastatic capacity of the malignant tissue, and (iii) improvement in immune infiltrating into the tumor (Paper published in Clinical Cancer Research, 2017). Herein, the investigators propose to conduct a double-blind placebo-controlled two-arm Phase II clinical trial in 200 colorectal cancer patients undergoing curative surgery in Israel. A perioperative 20-day drug treatment will be initiated 5 days before surgery. Primary outcomes will include (i) 3-year disease-free-survival (DFS), and 5-year overall survival (OS); and (ii) biological markers in blood samples, and in the excised tumor tissue. Secondary outcomes will include safety indices and psychological measures of depression, anxiety, distress, and fatigue

Colorectal Metastasis Prevention International Trial 2

Perioperative Use of a β-adrenergic Blocker, Propranolol, and a COX2 Inhibitor, Etodolac, in Patients Undergoing Resection With Curative Intent for Primary Colon and Rectal Cancer: Effect on Tumor Recurrence and Survival

Data regrading post-surgical recurrence will be recorded at 1,3,6,12,18,24,36,48, and 60 following surgery. Primary outcome 1 will be rate of recurrence/disease at 60 months.

Epithelial-to-mesenchymal-transition ( EMT) status and natural-killer cell, macrophage, T-cell, and B-cell infiltration levels into tumor tissue (as assessed by messenger RNA profiling of tissue samples

Rabin Medical Center

Tel-Aviv Sourasky Medical Center

Rambam Health Care Campus

HaEmek Medical Center, Israel

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Perioperative Intervention to Reduce Metastatic Processes in Pancreatic Cancer Patients Undergoing Curative Surgery	NCT03838029	Pancreatic Neop...	Propranolol and... Placebo	20 Years - 80 Years	Assaf-Harofeh Medical Center
A Study Comparing Perioperative Stress Reduction vs. Standard of Care in Ovarian Cancer (PRESERVE)	NCT05429970	Ovarian Cancer Ovarian Carcino... Stage II Ovary ... Stage II Ovaria... Stage III Ovary... Stage III Ovari... Stage IV Ovary ... Stage IV Ovaria... Epithelial Ovar... Fallopian Tube ... Stage II Fallop... Stage III Fallo... Stage IV Fallop... Primary Periton...	Mind-body resil... Music therapy Propranolol Etodolac	18 Years -	Memorial Sloan Kettering Cancer Center
Perioperative Intervention to Reduce Metastatic Processes in Pancreatic Cancer Patients Undergoing Curative Surgery	NCT03838029	Pancreatic Neop...	Propranolol and... Placebo	20 Years - 80 Years	Assaf-Harofeh Medical Center
Colorectal Metastasis Prevention International Trial 2	NCT03919461	Colorectal Neop...	Propranolol and... Placebo	20 Years - 80 Years	Assaf-Harofeh Medical Center
Colorectal Metastasis Prevention International Trial 2	NCT03919461	Colorectal Neop...	Propranolol and... Placebo	20 Years - 80 Years	Assaf-Harofeh Medical Center
A Study Comparing Perioperative Stress Reduction vs. Standard of Care in Ovarian Cancer (PRESERVE)	NCT05429970	Ovarian Cancer Ovarian Carcino... Stage II Ovary ... Stage II Ovaria... Stage III Ovary... Stage III Ovari... Stage IV Ovary ... Stage IV Ovaria... Epithelial Ovar... Fallopian Tube ... Stage II Fallop... Stage III Fallo... Stage IV Fallop... Primary Periton...	Mind-body resil... Music therapy Propranolol Etodolac	18 Years -	Memorial Sloan Kettering Cancer Center

Spots Global Cancer Trial Database for etodolac

Every month we try and update this database with for etodolac cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for etodolac

Every month we try and update this database with for etodolac cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for etodolac cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.