Chemotherapy-Induced Peripheral Neuropathy
Conditions
Interventions
electroacupuncture group:electroacupuncture
sham electroacupuncture group:sham electroacupuncture
Sponsors
School of Acupuncture-Moxibustion and Tuina Beijing University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Aged between 18-75 years old male or female; (2) Patients diagnosed with cancer with the stage of cancer limited to stage I-III and no restriction on the type of cancer; (3) Patients receiving their first chemotherapy regimen containing oxaliplatin or paclitaxel or albumin-conjugated paclitaxel with a chemotherapy regimen based on a 21-day cycle of six or eight cycles; (4) Expected survival of at least 9 months; (5) An Eastern Cooperative Oncology Group (ECOG) physical status score of 0-2; (6) No language or intellectual disabilities and can answer and complete the questionnaire without difficulty; (7) Subjects or their guardians voluntarily signed an informed consent form.
Exclusion criteria
Exclusion criteria: (1) Patients who have received previous chemotherapy; (2) History of other diseases that can cause neuropathy such as diabetes multiple sclerosis AIDS Parkinson's disease and peripheral neuropathy; (3) Patients who are receiving any of the following medications used to treat CIPN are excluded: glutamine gabapentin nortriptyline amitriptyline or duloxetine hydrochloride (HCL) vitamin E and other nutritional supplements used to treat CIPN; (4) Taking medications that may cause exacerbation of peripheral neuropathy; (5) Suffering from acute illnesses infectious diseases and unstable cardiovascular disease hepatic or renal insufficiency or other malignant diseases; (6) Those who have received acupuncture treatment within the past month and have skin lesions or infections at the site of needling; (7) Patients with known coagulation disorders or taking anticoagulant drugs; (8) Pregnant and lactating women; (9) Suspected or confirmed history of alcohol and drug abuse; (10) Patients participating in other clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in EORTC QLQ-CIPN20 score at the end of the 3rd chemotherapy cycle; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects completing cycles of chemotherapy;Credibility and expectation evaluation;Prevalence of CIPN;Blinded evaluation;Change from baseline in Insomnia Severity Index ISI score;Number of cycles in which CIPN first occurred;Use of emergency drugs;Change from Baseline in Generalised Anxiety Scale GAD-7 Score;Change from baseline in EORTC QLQ-CIPN20 score;adverse events;Incidence of chemotherapy drug reduction or delayed treatment due to CIPN;Change from Baseline in Beck Depression Inventory BDI-II Scores;Change from baseline in NRS score;Change from baseline in Brief Fatigue Inventory BFI score; | — |
Countries
China
Contacts
Public ContactCunzhi Liu
School of Acupuncture-Moxibustion and Tuina Beijing University of Chinese Medicine
Outcome results
None listed