A Randomized controlled study to evaluate the role of Hydroxy-progesterone in prevention of chemotherapy induced neurotoxicity in women with breast cancer - Hydroxy Progesterone in reduction of chemotherapy induced neurotoxicity in breast cancer

Tata Memorial Centre0 个研究点目标入组 240 人开始时间: 待定最近更新: 2021年11月24日

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•1 Post-menopausal women up to 75 years of age.
•2 Breast cancer patients with clinically operable or locally advanced stage of disease being planned for taxane based chemotherapy in the adjuvant or neoadjuvant setting.
•3 Patients with adequate baseline marrow function defined as ANC > 1500/mm3 and Platelet count > 1, 00,000/mm3.
•4 Patients with acceptable liver function tests (normal bilirubin and AST/ALT < 2 times the upper limit of normal) and normal renal function tests at baseline.
•5 Patients willing to provide informed consent.
•6 Patients fit for chemotherapy with adequate cardiac reserve (defined as baseline LVEF >40%)
•7 Taxane naive patients.

•1 Inflammatory breast cancer patients.
•2 Pre-existent neuropathy (e.g. diabetes neuropathy, plexopathy, alcohol, toxin, hereditary or any other cause) of any grade.
•3 Patients with presence of neuropathic pain or peripheral polyneuropathy or identified causes of painful paresthesia including radiotherapyâ??induced or malignant plexopathy, lumbar or cervical radiculopathy existing prior to baseline.
•4 Patients with a prior history of any malignancy.
•5 Uncontrolled hypertension or other cardiac abnormalities.
•6 Patients who are illiterate compromising their ability to fill out the CIPN questionnaire.

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