Chemotherapy Induced Peripheral Neuropathy (CIPN)

Completed · Not applicable

Conditions studied: Chemotherapy-induced Peripheral Neuropathy

In brief

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 sensation, pain (of various intensities in the extremities), gait/balance problems, and difficulty with fine motor skills of the hands and fingers.To date, there are no preventive modalities to mitigate CIPN development.When CIPN becomes intolerable, optimal doses of chemotherapy have to be reduced or discontinued, which may affect a patient's overall survival. Intraneural facilitation (INF) is a technique developed by physical therapists at Loma Linda University after careful study of the structure, pathophysiology and biomechanics of peripheral nerves. The focus of INF is restoration of circulation to an ischemic nerve. INF has been offered to subjects receiving treatment at LLUCC with anecdotal success. The purpose of this study is to evaluate INF as a treatment modality under the rigor of scientific inquiry to determine its effectiveness as a viable treatment option for breast cancer patients with CIPN.

Key facts

Study ID

NCT03272919

Run by

Loma Linda University

People needed

44

Starts

2017-09-28

Expected to finish

2022-05-25

Last updated by the study team

2023-05-10

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Loma Linda Medical Center — Loma Linda, California, United States

Full record on ClinicalTrials.gov

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