A Study on the Improvement of Postoperative Symptoms and Survival Benefits of Modified Bufei Decoction in Elderly Patients With Lung Cancer Undergoing Radical Surgery

Peking University Cancer Hospital & Institute

Status: Enrolling

Conditions: Lung Cancers

Treatments: Drug: Placebo; Other: Jiawei Bufei Tang granules

Study type: Interventional

Funder types: Other

Identifiers

NCT06674252

JWBF-1

Details and patient eligibility

About

This is a randomized double-blind placebo-controlled phase II clinical study that included patients with symptoms such as cough, shortness of breath, and fatigue after lung cancer resection surgery. They were given orally modified Bufei Tang granules twice a day for 28 days, with one packet taken orally with water. Using the MDASI-TCM symptom scoring system, evaluate the scores of symptoms such as cough, shortness of breath, and fatigue before and after the experiment, and calculate the difference in scores between the control group and the experimental group before and after the experiment.

Full description

This study is a multicenter, randomized, double-blind, placebo-controlled clinical trial to verify the effectiveness of the traditional Chinese medicine compound Jiawei Bufei Tang in improving postoperative clinical symptoms in elderly lung cancer patients and providing effective treatment methods for improving patients' quality of life.

1. Research Design: A multicenter, randomized double-blind placebo-controlled study was conducted, in which eligible subjects were randomly assigned to a treatment group and a control group in a 1:1 ratio, with 87 cases in each group.
2. The process of participant participation in the experiment The composition of Jiawei Bu Fei Tang includes Huangqi, Codonopsis pilosula, Schisandra chinensis, Rehmannia glutinosa, Ziyuan, Mulberry bark, Snake berry, Half branch lotus, White Hedyotis diffusa, Bai Qian, and Platycodon grandiflorum. A traditional Chinese medicine placebo is formulated with caramel color, dextrin, and bittering agent to create a placebo with an appearance and taste similar to the treatment group's medication. Both the therapeutic drug and placebo were tested using independently packaged non decoction granules produced by the same company and batch.

On the 7th day after surgery, patients were screened and evaluated using the MDASI-TCM scale. Subjects with postoperative symptoms such as fatigue, cough, and shortness of breath who met the inclusion criteria but did not meet the exclusion criteria were included in the clinical study and randomly assigned to receive oral medication treatment in a 1:1 ratio.

On the day of inclusion, the patient was randomized and successfully received the trial medication, with the first oral administration of traditional Chinese medicine within 24 hours.

Treatment group (Modified Bufei Decoction):

Usage of traditional Chinese medicine: Take orally 1 bag/time of Jiawei Bufei Tang, twice a day, starting from the 7th day after surgery (the day of enrollment), for 28 consecutive days.

Control group (placebo):

Usage of placebo: Take 1 bag of placebo orally, twice a day, starting from the 7th day after surgery (the day of enrollment), for 28 consecutive days.

If the subject experiences discomfort during the medication process, unblinding or withdrawal from the study can be based on the researcher's judgment.

Enrollment: 174 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with postoperative lung cancer who have clear histological or cytological diagnosis.

  • Age ≥ 65 years old, both male and female are eligible. According to the MDASI-TCM scale evaluation, any of the three symptoms of cough, fatigue, and shortness of breath should score ≥ 4 points, or the sum of the three should score ≥ 6 points.

    • The heart function is basically normal; ALT/AST is within 2 times the normal value; SCr is within the normal range.

Traditional Chinese medicine syndrome differentiation is characterized by deficiency of both lungs and kidneys.

Exclusion criteria

• Patients with severe pulmonary infections. ⑵. Patients with mental illness. ⑶. Patients with depression.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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174 participants in 2 patient groups, including a placebo group

Jiawei Bufei Tang

Experimental group

Description:

Oral administration of Jiawei Bufei Tang granules for 28 days, twice a day, 1 packet each time, and the medication must be taken with water.

Treatment:

Other: Jiawei Bufei Tang granules

Placebo granules

Placebo Comparator group

Description:

Take placebo granules orally for 28 days, twice a day, 1 pack each time, and the medication must be taken with water.

Treatment:

Drug: Placebo