Dexamethasone, Flurbiprofen Axetil and Long-term Survival After Lung Cancer Surgery

NCT03172988 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2019-03-05

No results posted yet for this study

Summary

Surgical resection is the first choice treatment for patients with non-small-cell lung cancer. Despite of advances in surgical techniques, the long-term survival rate of postoperative patient is far from optimal. In a recent retrospective cohort study of the applicants, 588 patients after surgery for non-small-cell lung cancer were followed up for a medium of 5.2 years. The results showed that perioperative use of dexamethasone was associated with prolonged survival; perioperative use of flurbiprofen axetil was also associated with a slightly longer survival but not statistically significant. Further analysis showed that combined administration of dexamethasone and flurbiprofen axetil had additive effect in prolonging survival. We hypothesize that, for patients undergoing surgery for non-small-cell lung cancer, perioperative administration of dexamethasone and flurbiprofen axetil may improve long-term survival. However, evidences from randomized controlled trials are still lacking in this aspect.

Conditions

  • Carcinoma, Non-Small-Cell Lung
  • Surgery
  • Dexamethasone
  • Flubiprofen Axetil
  • Long-term Effects Secondary to Cancer Therapy in Adults

Interventions

DRUG

Dexamethasone

Dexamethasone 10 mg is administered before anesthesia induction.

DRUG

Normal saline

Normal saline 2 ml is administered before anesthesia induction.

DRUG

Flurbiprofen axetil

Flurbiprofen axetil 50 mg is administered before the start of surgery. Postoperative analgesia is provided with a patient-controlled analgesia pump, which is established with 100 ml of 1.25 μg/ml sufentanil and 2 mg/ml flurbiprofen axetil, programmed to deliver a 2 ml bolus with a lockout interval of 6-8 min and a background infusion of 1 ml/h.

DRUG

Lipid microsphere

Lipid microsphere 5 ml is administered before the start of surgery. Postoperative analgesia is provided with a patient-controlled analgesia pump, which is established with 100 ml of 1.25 μg/ml sufentanil and 20 ml lipid microsphere, programmed to deliver a 2 ml bolus with a lockout interval of 6-8 min and a background infusion of 1 ml/h.

Sponsors & Collaborators

  • Peking University Cancer Hospital & Institute

    collaborator OTHER
  • Peking University First Hospital

    lead OTHER

Principal Investigators

  • Dong-Xin Wang, MD, PhD · Peking University First Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-02
Primary Completion
2018-12-26
Completion
2018-12-26

Countries

  • China

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03172988 on ClinicalTrials.gov