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

ConditionLung Cancers
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorPeking University Cancer Hospital & Institute

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Jiawei Bufei Tang granules

    Other intervention

    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

  • Placebo

    Drug

    placebo

Treatment groups

174 Participants
are divided into 2 treatment groups
Group A: Jiawei Bufei TangExperimental treatment 1 intervention
Group B: Placebo granulesPlacebo comparator 1 intervention

Trial outcomes

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.

Time frame
28 days

Secondary outcomes

1

QLQ-C30 scale

Compare the QLQ-C30 scale scores before and after the trial between the modified Bufei Decoction group and the placebo group

Time frame
28 days
2

CGA assessment

Compare the CGA assessment results of elderly patients before and after the trial between the modified Bufei Decoction group and the placebo group

Time frame
28 days
3

DFS

Record the difference in DFS between the modified Bufei Decoction group and the placebo group.

Time frame
28 days

Other outcomes

Sponsors and contacts

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