Health TrialsbyHealthPanel

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

ConditionGastrointestinal Tumors
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorHuashan Hospital

About this trial

In this study, perioperative propranolol β-blockade was administered to patients with surgically resectable primary gastrointestinal tumors to explore the safety, efficacy, and alleviation of perioperative psychological stress. At the same time, a multi-omics study was conducted using clinical samples to explore the activation of anti-tumor immune response and its mechanism.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Surgically resectable primary gastric cancer and colorectal cancer;

Age greater than 18 years old and less than 65 years old;

Negative pregnancy test for women of childbearing age;

ECOG score ≤2;

Disqualifiers

Pathological sinus node syndrome;

Sinus bradycardia (less than 60 beats/minute);

First, second or third degree AV block;

Resting blood pressure less than 100/60 mmHg;

Trial design

Design model

Single group

Treatments tested in this trial

  • propranolol (beta-blocker used treat high blood pressure)

    Drug

    Enrolled patients began receiving propranolol alone orally twice daily (10 mg bid) 10-14 days prior to surgery, and after 3 days of treatment, the dose of propranolol was increased to 20 mg bid daily until the day of surgery if the following three predefined criteria were met: systolic blood pressure greater than 90 mmHg, heart rate greater than 60 bpm, and no significant symptoms (e.g., syncope, insomnia, fatigue). The patient continues to be treated from 1 week after surgery.From 1 week after surgery, patients continue propranolol for 3 weeks. Patients will be monitored daily for symptoms, blood pressure, and heart rate and will be followed for observation at 6, 12, and 24 months after surgery until disease progression or clinical death, unless intolerable toxicity occurs and the patient refuses to continue treatment. The efficacy and safety of the preoperative propranolol β-blockade regimen in patients with gastrointestinal tract tumors was evaluated using the study objectives in S

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: propranolol (beta-blocker used treat high blood pressure)+surgeriesExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Anxiety Depression Scale Scores

Hamilton Anxiety Scale. The higher the score, the worse the symptoms.

Time frame
Within two years of enrollment
2

heart rate

Sympathetic nervous system activation index

Time frame
From enrollment to 24 days postoperatively
3

Heart rate variability

Sympathetic nervous system activation index

Time frame
From enrollment to 24 days postoperatively
4

blood preasure

Sympathetic nervous system activation index

Time frame
From enrollment to 24 days postoperatively

Secondary outcomes

1

2-year OS rate

Time frame
Two years after surgery
2

2-year RFS rate

Time frame
Two years after surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Huashan Hospital

Lead sponsor

Source ClinicalTrials.gov
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