Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Tel-Aviv Sourasky Medical Center | OTHER_GOV |
| Rabin Medical Center | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Colon and rectal cancer is the second most prevalent malignant disease in the western world, causing significant morbidity, mortality, and healthcare sources use. Treating colon and rectal cancer with curative intent generally includes resection of the primary tumor. Despite its crucial role, surgery by itself induce physiological changes resulting in significant immune depression and other physiological perturbations, which may in turn play a significant role in the initiation of new metastases and the progression of pre-existing dormant metastases. The aim of this study is to assess the use of perioperative medical intervention using a combination of a β-adrenergic blocker (Propranolol) and a COX2 inhibitor (Etodolac), in order to attenuate the surgically induced immunosuppression and other physiological perturbations, aiming to reduce the rate of tumor recurrence and distant metastatic disease.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Perioperative Propranolol and Etodolac |
|
| 2 | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Propranolol and Etodolac | Drug | Both study medications will be given orally for an intervention phase of 20 days as follows: 5 days prior to surgery, on the day of surgery, and 14 days postoperatively. Etodolac:800 mg 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, 40 mg PO bid for the first postoperative week, 20 mg PO bid for the second postoperative week. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of recurrent and metastatic cancer | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| magnitude and duration of surgically induced immune depression, as reflected in the blood samples | early postoperative | |
| Early postoperative morbidity and mortality | 30 days |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Oded Zmora, M.D. | Contact | 972-3-5302247 | ozmora@post.post.tau.ac.il |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rabin- Beilinson Medical Center | Not yet recruiting | Petah Tikva | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42088573 | Derived | Sakis N, Sorski L, Asraf E, Ricon-Becker I, Shaashua L, Haldar R, Shvalbo BB, Shabat-Simon M, Gutman M, Nissan A, Nachmany I, Kent I, Pery R, Pencovich N, Shussman N, Wasserberg N, Reshef A, Quint E, Lishtzinsky YY, Kashtan H, Shabtai M, Brenner B, Sharon E, Allweis T, Shahar N, Eckerling A, Sandbank E, Zmora O, Ben-Eliyahu S. Favorable safety outcomes of a perioperative propranolol and etodolac regimen in cancer patients in four randomized controlled trials. Front Pharmacol. 2026 Apr 20;17:1823113. doi: 10.3389/fphar.2026.1823113. eCollection 2026. | |
| 24050955 |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
Not provided
Not provided
| ID | Term |
|---|---|
| D011433 | Propranolol |
| D017308 | Etodolac |
| ID | Term |
|---|---|
| D050198 | Phenoxypropanolamines |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Tel Aviv-Sourasky Medical Center | Not yet recruiting | Tal Aviv | Israel |
|
| Sheba Medical Center | Recruiting | Tel Litwinsky | 45858 | Israel |
|
| Derived |
| Hicks BM, Murray LJ, Powe DG, Hughes CM, Cardwell CR. beta-Blocker usage and colorectal cancer mortality: a nested case-control study in the UK Clinical Practice Research Datalink cohort. Ann Oncol. 2013 Dec;24(12):3100-6. doi: 10.1093/annonc/mdt381. Epub 2013 Sep 19. |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D009930 |
| Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D007210 | Indoleacetic Acids |
| D000147 | Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |