Clinical trial · Interventional
Chemotherapy Induced Peripheral Neuropathy (CIPN)
Chemotherapy Induced Peripheral Neuropathy (CIPN): A Pilot Study of Intraneural Facilitation for Managing Chemotherapy-Induced Peripheral Neuropathy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemotherapy-induced Peripheral Neuropathy | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Arm 1: Investigational INF | Other | — | UNRESOLVED |
| Arm 2: standardized muscle stretching and strength | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm 1: Investigational INF
- description
- Intraneural Facilitation (INF) treatment is an effective way to restore blood flow to damaged nerves as neuropathy is strongly impacted by reduced blood flow.
- interventionNames
- Other: Arm 1: Investigational INF
- type
- OTHER
- label
- Arm 2: Standardized muscle stretching and strengthen
- description
- subjects will receive a standardized program of muscle stretching and strengthening exercise twice a week for six weeks under the supervision of treating physical therapist
- interventionNames
- Other: Arm 2: standardized muscle stretching and strength
Primary outcomes (4)
- measure
- Descriptive Statistics to measure the degree of peripheral neuropathy in the two arms based on the PQAS score.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * 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
References
Publications (1)
- DERIVEDHankins J, Bussell M, Gharibvand L, Jeon WJ, Castillo DR, D'Errico E, Nagaraj G. A Novel Approach of Intraneural Facilitation Versus Standard Physical Therapy for the Prevention of Chemotherapy-Induced Peripheral Neuropathy: A Randomized Controlled Trial. Integr Cancer Ther. 2026 Jan-Dec;25:15347354251413222. doi: 10.1177/15347354251413222. Epub 2026 Mar 16. PMID 41840756