Status:
COMPLETED
Chemotherapy Induced Peripheral Neuropathy (CIPN)
Lead Sponsor:
Loma Linda University
Conditions:
Chemotherapy-induced Peripheral Neuropathy
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
Chemotherapy induced peripheral neuropathy (CIPN) is a common side effect of many forms of chemotherapy having a negative impact on the quality of life for cancer survivors due to numbness, decreased ...
Detailed Description
STUDY OUTLINE: This is a single institution study. Patients with newly diagnosed breast cancer stages I to III with any biomarker status (ER, PR and HER), without preexisting peripheral neuropathy pla...
Eligibility Criteria
Inclusion
- Newly diagnosed stages I to III breast cancer patients with any biomarker status (ER, PR and HER) receiving treatment with platinum-based compounds (Carboplatin and Cisplatin) and/or taxanes (Docetaxel and Paclitaxel).
- Chemotherapy naive patients with gynecologic cancers including ovarian, uterine, and cervical cancer planning to receive definitive number of platinum-based compounds (carboplatin or cisplatin) and/or taxanes (docetaxel and paclitaxel) chemotherapy.
- Planned to receive a minimum of 4 cycles of treatment with either of the offending chemotherapy agents (a cycle of weekly paclitaxel is considered 3 doses).
- Women aged ≥ 18 years at signing of informed consent
- No pre-existing peripheral neuropathy (WPPN)
- ECOG status 0 or 1
- Able to provide written, informed consent to participate in the study and follow the study procedures.
- Cannot participate in another non-medical intervention/therapy for peripheral neuropathy
- Cannot receive more than 3 weeks of treatment with implicating chemotherapy prior to start of study assigned therapy.
Exclusion
- Male
- Preexisting peripheral neuropathy.
- Previous exposure to any of the implicated chemotherapy agents within the last 5 years (platinum-based compounds, vinca alkaloids and/or taxanes) that could potentially cause peripheral neuropathy
- Evidence of significant medical illness, or psychiatric illness/social situation that would, in the investigator's judgment, make the patient inappropriate for this study.
- Stage IV or metastatic breast cancer
- Any physical or neurological disability that would preclude patients from participating in physical therapy
Key Trial Info
Start Date :
September 28 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 25 2022
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT03272919
Start Date
September 28 2017
End Date
May 25 2022
Last Update
May 10 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Loma Linda Medical Center
Loma Linda, California, United States, 92354