Efficacy Study of Comprehensive Rehabilitation Program Plus Chemotherapy in Postoperative NSCLC Patients

Summary

The investigators performed a multi-centered, randomized, placebo-controlled, prospective clinical trial on the effect of comprehensive rehabilitation program plus chemotherapy to improve quality of life(QOL) and long-term survival of postoperative non small cell lung cancer（NSCLC）patients with high risk stages IB to IIIA. The investigators plan to enroll 354 cases in 3 years (118 cases for chemotherapy plus rehabilitation training and traditional Chinese medicine (TCM), 118 cases for chemotherapy plus rehabilitation education and TCM,118 cases for chemotherapy plus rehabilitation education and placebo), expecting that comprehensive rehabilitation program plus chemotherapy has a better efficacy on improving QOL and long-term survival.

Timeline

Start

2016-10-01

Primary completion

2019-09-30

Completion

2019-12-30

Outcome

Met primary endpoint

paper A significant between-group difference in the LSM GHS/QoL score was observed, amounting to 31.63 points (95% CI 25.61 to 37.64, P<0.001). PMID 39266862 ↗

Publications

• Zhang YL, Jiao LJ, Gong YB, Xu JF, Ni J, Shen XY, Zhang J, Zhou D, Qian CX, Wang Q, Yao JL, Yang WX, Su LZ, Wang LY, Li JQ, Yao YQ, Zhang YH, Wang YC, Chen ZW, Xu L. Patient-Reported Outcomes of Postoperative NSCLC Patients with or without Staged Chinese Herb Medicine Therapy during Adjuvant Chemotherapy (NALLC 2): A Randomized, Double-Blind, Placebo-Controlled Trial. Chin J Integr Med. 2024 Nov;30(11):963-973. doi: 10.1007/s11655-024-4114-9. Epub 2024 Sep 12.
• Yao J, Jiao L, Yao Y, Lu Y, Shi J, Li J, Chen P, Xu L, Gong Y. The effect of comprehensive rehabilitation program plus chemotherapy on quality of life in patients with postoperative non-small-cell lung cancer: study protocol of a multicenter randomized clinical trial. Trials. 2020 Apr 3;21(1):309. doi: 10.1186/s13063-020-4162-1.

Drugs

Indications