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

NCT06674252 | Recruiting

• 1 other identifier: JWBF-1
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 2

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.

Conditions

Lung Cancers

Outcome Measures

Primary Outcomes (1)

• MDASI-TCM scale

  The symptom score results of the MDASI-TCM scale between the oral Chinese medicine group and the placebo group after 28 days of medication.

  28 days

Secondary Outcomes (3)

• QLQ-C30 scale

  28 days

• CGA assessment

  28 days

• DFS

  28 days

Study Arms (2)

Jiawei Bufei Tang

EXPERIMENTAL

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.

Other: Jiawei Bufei Tang granules

Placebo granules

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Placebo DRUG

placebo

Placebo granules

Jiawei Bufei Tang granules OTHER

Jiawei Bufei Tang is a traditional Chinese medicine formula applied by Professor Li Pingping to patients with lung cancer and qi yin deficiency syndrome. It consists of Huangqi, Codonopsis pilosula, Schisandra chinensis, Rehmannia glutinosa, Ziyuan, Mulberry bark, Snake berry, Half branch Lotus, White Hedyotis diffusa, etc. Bu Fei Tang is derived from the Yuan Dynasty's "Yong Lei Ling Fang" and consists of six ingredients: ginseng, astragalus, schisandra, Radix Rehmanniae, Ziyuan, and mulberry bark. It is mainly used to treat cough caused by lung qi deficiency. Jiawei Bufei Tang adds white Hedyotis diffusa, Scutellaria barbata, and snake berry to the original formula. White Hedyotis diffusa is more effective in dispelling carbuncles and detoxifying, Scutellaria barbata is more effective in dispelling phlegm and diuresis, and snake berry is more effective in dispelling scrofula and dispersing nodules, increasing the effect of clearing heat and detoxifying. This formula is particularly e

Jiawei Bufei Tang

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Peking University Cancer Hospital & Institute: lead

Study Sites (2)

Beijing cancer hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

Beijing cancer hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Xu yi chen, MD

CONTACT

0086+15801096968; xxxxyc@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2024
• First Posted: November 5, 2024
• Study Start: June 13, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

CN (2)