Actively Recruiting

Phase 2
Age: 18Years - 65Years
All Genders
ID06775080

The Use of Propranolol Around Surgery for Resectable Gastrointestinal Tumors and Its Immune Response Effects

Led by Huashan Hospital · Updated on 2025-01-14

40

Participants Needed

1

Research Sites

125 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the safety, effectiveness, and impact on psychological stress of giving propranolol beta-blockade around the time of surgery to patients with surgically removable primary gastrointestinal tumors. This phase 2 exploratory pilot study also includes a multi-omics analysis using clinical samples to investigate how the anti-tumor immune response is activated and its underlying mechanisms. In this single-center study, 40 patients with resectable primary gastric or colorectal cancer are enrolled and randomly assigned to two groups. The treatment group receives oral propranolol twice daily starting 10 to 14 days before surgery, with the dose increased after 3 days if certain safety criteria are met, and continued for 3 weeks after surgery. The control group receives no propranolol. Patients are monitored during treatment and followed up at 6, 12, and 24 months post-treatment. Participants undergo regular assessments including heart rate, blood pressure, norepinephrine levels, blood glucose, oxygen saturation, and psychological evaluations up to 24 days after surgery. Tumor tissue and blood samples are collected before and during surgery for RNA sequencing, flow cytometry, and ELISA testing. Researchers track anxiety and depression scores over two years and monitor safety and efficacy throughout the study period until disease progression or death.

CONDITIONS

Official Title

The Use of Propranolol in the Perioperative Period of Resectable Gastrointestinal Tumors

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Surgically resectable primary gastric cancer or colorectal cancer
  • Age greater than 18 years and less than 65 years
  • Negative pregnancy test for women of childbearing age
  • ECOG performance status score of 2 or less
  • Signed informed consent
  • Resting blood pressure greater than 100/60 mmHg and heart rate greater than 60 beats per minute
Not Eligible

You will not qualify if you...

  • Pregnant or breastfeeding women, or women planning pregnancy within six months
  • Patients with contraindications to propranolol including sinus node syndrome, sinus bradycardia (less than 60 bpm), or any degree of AV block
  • Resting blood pressure less than 100/60 mmHg
  • Untreated pheochromocytoma or thyroid disease
  • Use of calcium channel blockers such as diltiazem, verapamil, nifedipine, or amlodipine
  • Severe peripheral vascular disease
  • Use of antiarrhythmic drugs like amiodarone, sotalol, or digoxin
  • Renal insufficiency defined as creatinine clearance greater than 0.15 mmol/L
  • Hepatic insufficiency with liver enzymes or bilirubin above specified limits
  • Use of medications including colistin, digoxin, rizatriptan, cimetidine, hydralazine, guanethidine, or ergotamine
  • History of major depressive episodes
  • Surgery for gastrointestinal tumors within the previous six months
  • Receiving neoadjuvant chemotherapy before planned surgery
  • Use of anxiolytic drugs such as benzodiazepines or alpha-adrenergic agonists
  • Use of selective or non-selective beta-adrenergic inhibitors within the last three months
  • History of stroke
  • Moderate or severe asthma requiring hospitalization or oral steroids
  • Other reasons determined by the physician for exclusion

AI-Screening

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Trial Site Locations

Total: 1 location

1

Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, China, 200040

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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