Clinical trial NCT06674252: A Study on the Improvement of Postoperative Symptoms and Survival Benefits of Modified Bufei Decoction in Elderly Patients With Lung Cancer Undergoing Radical Surgery
Official title: A Randomized Controlled Multicenter Study on the Improvement of Postoperative Symptoms and Survival Benefits of Modified Bufei Decoction in Elderly Patients With Lung Cancer Undergoing Radical Surgery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Lung Cancers
Lead sponsor: Peking University Cancer Hospital & Institute
Sponsor class: OTHER
First posted: 2024-11-05
Enrollment: 174
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: MDASI-TCM scale
timeFrame: 28 days
Secondary outcomes:
measure: QLQ-C30 scale
timeFrame: 28 days
measure: CGA assessment
timeFrame: 28 days
measure: DFS
timeFrame: 28 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing cancer hospital
state: Beijing
Study officials:
References: