Lung Cancer/Breast Cancer
Conditions
Interventions
conventional treatment+sham acupuncture group(Trail 2 Breast cancer):conventional treatment+sham acupuncture
conventional treatment+sham acupuncture group(Trail 1 Lung cancer):conventional treatment+sham acupuncture
conventional treatment+acupuncture(Trail 2 Breast cancer):conventional treatment+acupuncture
conventional treatment+acupuncture(Trail 1 Lung cancer):conventional treatment+acupuncture
Sponsors
Chengdu Pidu District Traditional Chinese Medicine Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Trial 1 (Lung Cancer): 1.Age 18–80 years; 2.Western medical diagnosis meeting the diagnostic criteria for lung cancer; 3.Meeting the diagnostic criteria for cancer-related fatigue (CRF) with CRF occurring after confirmed lung cancer diagnosis and persisting =1 month due to the malignancy or cancer-related therapies; 4.Expected survival period >6 months; 5.Karnofsky Performance Status (KPS) score =60; 6.No use of medications potentially affecting efficacy evaluation within 1 week prior to enrollment; 7.Conscious capable of effective communication and completing assessments as scheduled and voluntarily signed the Informed Consent Form. Trial 2 (Breast Cancer): 1.Female aged 18–80 years; 2.Diagnosis of breast cancer per the Chinese Guidelines for Diagnosis and Treatment of Common Malignant Tumors; 3.Meeting the diagnostic criteria for insomnia per the Chinese Classification of Mental Disorders 3rd Edition (CCMD-3) or anxiety per the International Classification of Diseases 10th Revision (ICD-10)* with insomnia/anxiety occurring after confirmed breast cancer diagnosis and persisting =1 month due to the malignancy or cancer-related therapies; 4.Expected survival period >6 months; 5.Karnofsky Performance Status (KPS) score =60; 6.No use of medications potentially affecting efficacy evaluation within 1 week prior to enrollment; 7.Conscious capable of effective communication and completing assessments as scheduled and voluntarily signed the Informed Consent Form. Participants must meet all the above criteria for enrollment.
Exclusion criteria
Exclusion criteria: Trial 1 (Lung Cancer): 1.Severe pulmonary infection; 2.Pregnant or lactating women; 3.Local infection or severe skin lesions at acupuncture points; 4.Platelet count <50×10^9/L; 5.Patients with a history of needle syncope; 6.Severe dysfunction of major organs (e.g. heart liver kidneys); 7.Scheduled surgery during the trial period; 8.Alcohol and/or substance abuse or dependence; 9.Concurrent participation in other clinical trials; 10.Other conditions deemed by investigators to contraindicate trial participation. Trial 2 (Breast Cancer): 1.Pregnant or lactating women; 2.Local infection or severe skin lesions at acupuncture points; 3.Platelet count <50×10^9/L; 4.Patients with a history of needle syncope; 5.Severe dysfunction of major organs (e.g. heart liver kidneys); 6.Secondary insomnia caused by severe cancer pain tumor-induced airway obstruction or related somatic symptoms; 7.Scheduled surgery during the trial period; 8.Alcohol and/or substance abuse or dependence; 9.Concurrent participation in other clinical trials; 10.Long-term night shift work or irregular sleep-wake patterns; 11.Other conditions deemed by investigators to contraindicate trial participation. Participants meeting any one of the above criteria will be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| multidimensional fatigue inventory(Trail 1 Lung cancer);Hamilton Anxiety Scale(Trail 2 Breast cancer);Insomnia Severity Index(Trail 2 Breast cancer); | — |
Secondary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Index;European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30++Breast Cancer Module 23;Self-Rating Anxiety Scale;European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30+Lung Cancer 13;Revised Piper Fatigue Scale;Self-Rating Depression Scale; | — |
Countries
China
Contacts
Public ContactChen Xiaoqin
Chengdu University of TCM
Outcome results
None listed