This study will be an evaluation of the efficacy and safety of acupuncture to enhance the response rate of immunotherapy in advanced lung cancer. The main questions it aims to answer are 1. Does acupuncture heighten the response rate of immunotherapy in advanced lung cancer? 2. Does acupuncture heighten the safety of immunotherapy in advanced lung cancer? Researchers will compare acupuncture to sham acupuncture to see if acupuncture could enhance the response rate of immunotherapy in advanced lung cancer. Both groups will receive a standard anti-tumor Western medical treatment regimen (PD-1/PD-L1 inhibitor combined with chemotherapy), and the experimental and control groups will be treated with 4 cycles of acupuncture or sham-acupuncture on top of the anti-tumor treatment regimen, respectively. Patients were followed up every three weeks for the first three months and every three months thereafter to record any disease progression, adverse events, survival or mortality status, and so on.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
240
Both groups have a standard anti-tumor Western medical treatment regimen (PD-1/PD-L1 inhibitor combined with chemotherapy); the acupuncture group is combined with acupuncture treatment. The day of starting antitumor treatment for each cycle was D1; D1-D5 was performed by the investigator on the patient for 2 times of acupuncture treatment, once a day; D8-D13 and D15-D20 were operated by patients or family members, and the investigator remotely assisted via video to complete the press needle treatment 4 times each, once a day, for four consecutive synergistic cycles, for a total of 24 times. The main acupuncture points are Guanyuan (Ren Mai 4), Shangyintang (EX-HN3), Taiyang (EX-HN5), Taichong (Liv-3), Zusanli (ST-36), and Xin (CO-15).
Both groups have a standard anti-tumor Western medical treatment regimen (PD-1/PD-L1 inhibitor combined with chemotherapy); the sham acupuncture group is combined with sham acupuncture treatment. The day of starting antitumor treatment for each cycle was D1; D1-D5 was performed by the investigator on the patient for 2 times of sham acupuncture treatment, once a day; D8-D13 and D15-D20 were operated by patients or family members, and the investigator remotely assisted via video to complete the sham press needle treatment 4 times each, once a day, for four consecutive synergistic cycles, for a total of 24 times. The main acupuncture points are Guanyuan (Ren Mai 4), Shangyintang (EX-HN3), Taiyang (EX-HN5), Taichong (Liv-3), Zusanli (ST-36), and Xin (CO-15).
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
RECRUITINGGuang'anmen Hospital, Chinese Academy of Traditional Chinese Medicine
Beijing, Beijing Municipality, China
RECRUITINGHunan Provincial Integrated Traditional Chinese and Western Medicine Hospital
Changsha, Hunan, China
RECRUITINGObjective Response Rate
Time frame: At 0,4,7,10,13 weeks,6,9,12,15,18,21,24 months from randomization, until progression occurred
Disease Control Rate
Time frame: At 0,4,7,10,13 weeks,6,9,12,15,18,21,24 months from randomization, until progression occurred
Progression-Free Survival
Time frame: At 0,4,7,10,13 weeks,6,9,12,15,18,21,24 months from randomization, until progression occurred
Overall Survival
Time frame: At 0,4,7,10,13 weeks,6,9,12,15,18,21,24 months from randomization, until death occurred.
Eastern Cooperative Oncology Group Performance Status, ECOG PS
Levels 0 to 5, the lower the level, the better the physical condition.
Time frame: At 0,4,7,10,13 weeks,6,9,12,15,18,21,24 months from randomization, until death occurred
GAD-7
The total score range is 0-21 points, higher scores indicates worse results.
Time frame: At 0,4,7,10,13 weeks,6 months from randomization
PHQ-9
The total score range is 0-27 points, higher scores indicates worse results.
Time frame: At 0,4,7,10,13 weeks,6 months from randomization
Insomnia Severity Index
The total score range is 0-28 points, higher scores indicates worse results.
Time frame: At 0, 4, 7, 10, and 13 weeks and 6 and 9 months from randomization
Lung Cancer Symptom Scale
Each item is scored using the Visual Analog Scale (0-100mm), with higher scores indicating more severe symptom burden.
Time frame: At 0,4,7,10,13 weeks,6,9 months from randomization
weight
Time frame: At 0,4,7,10,13 weeks,6,9,12,15,18,21,24 months from randomization, until progression or death occurred
adverse event
Collect blood routine, liver function, kidney function, thyroid function, myocardial enzyme spectrum, incidence of adverse reactions, and immune therapy related adverse reactions. Record the type, grading, correlation with treatment, start and end time of adverse reactions
Time frame: At 0,4,7,10,13 weeks,6,9,12,15,18,21,24 months from randomization, until progression or death occurred
Duration of immunotherapy
Time frame: At 0,4,7,10,13 weeks,6,9,12,15,18,21,24 months from randomization, until immunotherapy is no longer used
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