Peripheral Neuropathy Due to Chemotherapy
Conditions
Keywords
Paclitaxel, Breast Cancer, Peripheral Neuropathy
Brief summary
Paclitaxel-induced peripheral neuropathy (PIPN) is one of the most dose-limiting side effects; it causes patients discomfort and pain and sometimes causes the termination of the chemotherapy cycles, leading to treatment failure. A lot of interventions have been tried to prevent PIPN, ensure complete administration of the chemotherapy cycles, and increase the survival rate. One of the promising interventions in the prevention of PIPN is Losartan. Losartan is an angiotensin receptor blocker (ARBs) and is used to treat hypertensive patients. There is strong evidence from different preclinical studies and retrospective cohort studies that Losartan has a neuroprotective effect. The purpose of our study is to investigate the efficacy of Losartan in the prevention of peripheral neuropathy associated with Paclitaxel treatment in Breast Cancer patients.
Interventions
DRUGLosartan
Using losartan to prevent paclitaxel-induced peripheral neuropathy
Sponsors
Future University in Egypt
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Females older than 18 years diagnosed with biopsy-confirmed breast cancer (Early breast cancer eligible for adjuvant or neoadjuvant) who are scheduled to receive paclitaxel 80 mg/m2.
Exclusion criteria
* Known hypersensitivity to Losartan. * Not Known Hypertensive patients * Not Known Diabetic patients * Treatment with Losartan/ARBs/ACE-I prior to the study. * Previous neuropathy * Renal impairment (Serum creatinine \> 2 mg/dl) * Significant liver disease: liver enzymes 2 folds the upper normal limit * Metastatic breast cancer * Pregnancy or lactation * Taking other medication for neuropathic pain * Significant Hypotension
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Development of paclitaxel-induced peripheral neuropathy | 12 weeks | Incidence and grading of paclitaxel-induced peripheral neuropathy (PIPN) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient QOL | 12 weeks | Patient quality of life will be assessed by Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) |
| Pain Severity | 12 Weeks | Pain intensity will be assessed through Visaul Analogue Scale Scale 0-10 |
| Serum biomarker | 12 weeks | Level of Nerve growth factor (NGF) in Serum |
Countries
Egypt
Outcome results
None listed