Chemotherapy Induced Peripheral Neuropathy (CIPN)

Overseen by Ellen D'Errico, PHD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Loma Linda University

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial is testing a physical therapy technique called INF, which improves blood flow to nerves damaged by chemotherapy. It targets breast cancer and gynecologic cancer patients who are at risk of developing nerve problems from their treatment. By restoring blood flow, INF aims to reduce symptoms like numbness and pain.

Research Team

Gayathri Nagaraj, MD

Principal Investigator

Loma Linda University Medical Center

Ellen D'Errico, PHD

Principal Investigator

Loma Linda University School of Nursing

Eligibility Criteria

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).

Exclusion Criteria

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

Treatment Details

Interventions

• Arm 2: standardized muscle stretching and strength (Behavioural Intervention)
• Investigational INF (Other)

Participant Groups

Group I: Arm 2: Standardized muscle stretching and strengthen Experimental Treatment 1 Intervention

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

Group II: Arm 1: Investigational INF Experimental Treatment 1 Intervention

Intraneural Facilitation (INF) treatment is an effective way to restore blood flow to damaged nerves as neuropathy is strongly impacted by reduced blood flow.

Who Is Running the Clinical Trial?

Loma Linda University

Lead Sponsor

Trials

322

Recruited

267,000+