Using Propranolol for Patients with Gastrointestinal Tumors Before Surgery

The Use of Propranolol in the Perioperative Period of Resectable Gastrointestinal Tumors and the Study of Its Immune Mechanism Research

This study is testing if giving propranolol, a beta-blocker, to patients with gastrointestinal tumors before surgery can help reduce stress and improve outcomes.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Huashan Hospital (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06775080 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effects of perioperative propranolol, a beta-blocker, on patients with surgically resectable primary gastrointestinal tumors, specifically gastric and colorectal cancers. The study is designed as a single-center, randomized controlled pilot exploratory trial involving 40 patients, who will be divided into treatment and control groups. The treatment group will receive propranolol for 10-14 days prior to surgery, while the control group will not receive the medication. The study aims to evaluate the safety and efficacy of propranolol, as well as its potential to alleviate psychological stress during the perioperative period, alongside a multi-omics analysis of clinical samples to understand the anti-tumor immune response.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 65 with surgically resectable primary gastric or colorectal cancer.

Not a fit: Patients who are pregnant, breastfeeding, or have contraindications to propranolol will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve surgical outcomes and reduce psychological stress for patients undergoing surgery for gastrointestinal tumors.

How similar studies have performed: While the use of beta-blockers in perioperative settings has been explored, this specific approach in gastrointestinal tumors is novel and not extensively tested.

Eligibility criteria

Inclusion Criteria:

1. Surgically resectable primary gastric cancer and colorectal cancer;
2. Age greater than 18 years old and less than 65 years old;
3. Negative pregnancy test for women of childbearing age;
4. ECOG score ≤2;
5. Signed informed consent.
6. Resting blood pressure greater than 100/60mmHg, heart rate greater than 60 beats per minute.

Exclusion Criteria：

1\) Pregnant or breastfeeding women, or women with pregnancy plans within six months; 2) Patients with absolute or relative contraindications to propranolol:

1. Pathological sinus node syndrome;
2. Sinus bradycardia (less than 60 beats/minute);
3. First, second or third degree AV block;
4. Resting blood pressure less than 100/60 mmHg;
5. untreated pheochromocytoma;
6. untreated thyroid disease;
7. Patients on dihydropyridine or non-dihydropyridine calcium channel blockers (e.g., diltiazem, verapamil, nifedipine, amlodipine);
8. Severe peripheral vascular disease (intermittent claudication);
9. Patients on antiarrhythmic drugs (e.g., amiodarone, sotalol, digoxin);
10. Patients with renal insufficiency (defined as creatinine clearance greater than 0.15 mmol/L);
11. Patients with hepatic insufficiency: AST or ALT or ALP \> 2.5 times the upper limit of normal (ULN), bilirubin \> 1.5 times the ULN, ALP \> 2.5
12. Patients using colistin, digoxin, rizatriptan, cimetidine, hydralazine, guanethidine, or ergotamine.
13. Patients with a history of major depressive episodes; 3) Patients who have undergone surgery for GI tumors within the previous six months; 4) Patients receiving neoadjuvant chemotherapy prior to planned gastrointestinal tumor resection; 5) patients using conventional anxiolytic drugs (e.g. benzodiazepines), alpha-adrenergic agonists (e.g. colistin); 6) Patients using selective or non-selective β-adrenergic inhibitors (e.g., propranolol, metoprolol, atenolol, sotalol) within the last three months; 7) Patients with a history of stroke; 8) Patients with moderate or severe asthma, defined as requiring hospitalization or oral steroid therapy; (9) Those who, in the opinion of the physician, have other reasons for not being included in the treatment.

Where this trial is running

Shanghai, Shanghai Municipality

• Huashan Hospital, Fudan University — Shanghai, Shanghai Municipality, China (RECRUITING)

Conditions: Gastrointestinal Tumors