Acupuncture as a modality of treatment for Chemotherapy-Induced Peripheral Neuropathy in Breast Cancer-A Phase 3 Randomized Controlled Trial (ABC-CIPN).

Tata Memorial Center0 个研究点目标入组 104 人开始时间: 待定最近更新: 2024年6月24日

试验速览

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•1 Patients with non metastatic breast cancer who have been experiencing grade 1 or greater CIPN for more than 1 week after completion of paclitaxel based chemotherapy
•2 Aged 18 or above
•3 ECOG performance status 0–1
•4 Ability to fill the self-reported questionnaire in any of the three languages (English, Hindi or Marathi).
•5 Normal blood counts defined as per WHO standards
•Female: Hemoglobin: 12.0-15.5 grams/dL, TLC-4000-11000 and PLC-1.5 lakhs to4 lakhs.

•1 ECOG performance status 2 or above
•2 Patients who have hyperalgesia or allodynia
•3 Patients having pre-existing causes of peripheral neuropathy like diabetic neuropathy, CKD
•4 Patients with bleeding disorders
•5 Unstable cardiac disease or myocardial infarction within 6 months prior to study entry
•6 Peripheral neuropathy caused by tumor infiltration or compression of spinal nerves or surgical trauma
•7 Pregnancy or potential pregnancy and nursing
•8 Active clinically significant uncontrolled infection
•9 Prior use of acupuncture for CIPN within 6 months prior to study entry
•10 Patients with uncontrolled major psychiatric disorders, such as major depression or psychosis, will not be eligible for this trial. Patients with a history of depression or anxiety who are stable on or off psychiatric medications will be eligible

发起方

Tata Memorial Center