To evaluate the role of Hydroxy-progesterone in prevention of chemotherapy induced neurotoxicity in women with breast cancer

Phase 3

• Conditions: Health Condition 1: null- Postmenopausal Nonmetastatic Breast Cancer Patients

• Registration Number: CTRI/2015/11/006381
• Lead Sponsor: Tata Memorial Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 240

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified