Chemotherapy Induced Peripheral Neuropathy (CIPN)

NCT03272919 | Completed

• 1 other identifier: 5170197
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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 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

Chemotherapy-induced Peripheral Neuropathy

Keywords

Breast Cancer, Peripheral neuropathy, Taxol, carboplatin

Outcome Measures

Primary Outcomes (4)

• Descriptive Statistics to measure the degree of peripheral neuropathy in the two arms based on the PQAS score.

  The 20 item PQAS measures self reported aspects of nociceptive and neuropathic pain (intensity, sensation, depth, location) on a scale of 0 to 10.

  upto 3 months post completion of assigned treatment

• Descriptive Statistics to measure the degree of distress in the two arms based on NCCN- DT

  Study participants self report distress based on National Comprehensive Cancer Network's Distress Thermometer (DT) measures distress on a scale of 0 = no distress, 10=extreme distress.

  upto 3 months post completion of assigned treatment

• Descriptive Statistics to measure the degree of peripheral neuropathy in the two arms based on MSNI scores

  The MSNI is a physical screening instrument of the lower legs and feet for the assessment of neuropathy using visual inspection, vibration sensation, ankle reflexes and monofilament testing producing a score of 0 being normal and 10 meaning significant neuropathy as measured by the assessing physical therapist

  upto 3 months post completion of assigned treatment

• Descriptive Statistics to measure the degree of peripheral neuropathy in the two arms based on CTCAE grading

  The CTCAE measures peripheral sensory neuropathy on a scale of 1=asymptomatic to 5=death as measured by the treating physician

  upto 3 months post completion of assigned treatment

Secondary Outcomes (4)

• Measure the peak systolic velocity on ultrasound imaging in the popliteal and posterior tibia artery in the two arms.

  upto 3 months post completion of assigned treatment

• Measure the rate of premature chemotherapy discontinuation due to peripheral neuropathy by treatment group

  upto 3 months post completion of assigned treatment

• Measure the rate of dose reductions in chemotherapy due to peripheral neuropathy by treatment group

  upto 3 months post completion of assigned treatment

• Questionnaire to survey patients on acceptability, satisfaction and burden of treatment

  upto 3 months post completion of assigned treatment.

Study Arms (2)

Arm 1: Investigational INF

EXPERIMENTAL

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

Other: Arm 1: Investigational INF

Arm 2: Standardized muscle stretching and strengthen

OTHER

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

Other: Arm 2: standardized muscle stretching and strength

Interventions

Arm 1: Investigational INF OTHER

INF utilizes three holds or positions, which widens tiny openings in arteries surrounding nerves and improves blood flow to targeted nerves. The improved blood flow in these nerves stimulates healing and reduces or even stops nerve pain.

Arm 1: Investigational INF

Arm 2: standardized muscle stretching and strength OTHER

subjects will receive a standardized program of muscle stretching and strengthening exercise under the supervision of treating physical therapist.

Arm 2: Standardized muscle stretching and strengthen

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Women aged ≥ 18 years at signing of informed consent
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (1)

Loma Linda Medical Center

Loma Linda, California, 92354, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Peripheral Nervous System Diseases

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Gayathri Nagaraj, MD

  Loma Linda University Medical Center

  PRINCIPAL INVESTIGATOR

• Ellen D'Errico, PHD

  Loma Linda University School of Nursing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: August 8, 2017
• First Posted: September 6, 2017
• Study Start: September 28, 2017
• Primary Completion: May 25, 2022
• Study Completion: May 25, 2022
• Last Updated: May 10, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)