- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03272919
Chemotherapy Induced Peripheral Neuropathy (CIPN)
Chemotherapy Induced Peripheral Neuropathy (CIPN): A Pilot Study of Intraneural Facilitation for Managing Chemotherapy-Induced Peripheral Neuropathy
Study Overview
Status
Conditions
Intervention / Treatment
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 planning to receive treatment with platinum-based compounds (Carboplatin and Cisplatin) and/or taxanes (Docetaxel and Paclitaxel) and 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 are potential study patients.
Subjects will be randomized into one of two treatment arms within 3 weeks of starting the offending chemotherapy agents after fulfilling the other study eligibility requirements. Arm 1 (investigational) will receive INF twice a week for six weeks by the same treating physical therapist (physical therapist #1). Arm 2 (control) will receive a standardized program of muscle stretching and strengthening exercises twice a week for 6 weeks under the supervision of treating physical therapist #1. Actual treatment time for both modalities is approximately 45 minutes. Measurements used to detect the presence and degree of peripheral neuropathy will be administered by the same assessment physical therapist (physical therapist #2) at baseline and at the end of weeks 3, 6, and 3 months post last physical therapy treatment. Assessment tools are: ultrasound imaging on the popliteal and posterior tibia artery, the 20-item Pain Quality Assessment Scale (PQAS, specifically addresses neuropathological symptomatology), the National Comprehensive Cancer Network (NCCN) Distress thermometer (DT), and the Michigan Neuropathy Screening Instrument (MNSI) will be assessed and recorded along with treatment adherence. Treating physician will be recording National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) neuropathy score and performance status at routine intervals during and after chemotherapy.
Objectives
Primary objective
• To compare the degree of neuropathy and distress between Arm 1 receiving INF therapy compared to Arm 2 receiving usual care of muscle stretching and strengthening exercises based on standardized measurements (PQAS, MNSI, NCCN DT, and AE assessment).
Secondary objectives
- To compare the Ultrasound measurements of peak systolic velocity, volume flow and pulsatility of popliteal and posterior tibia artery between the two treatment arms for assessing differences in vascular perfusion.
- To compare the rate of any dose reductions and premature chemotherapy discontinuation rates due to peripheral neuropathy between Arm 1 receiving INF therapy compared to Arm 2 receiving standardized program of muscle stretching and strengthening exercises.
- To compare subject acceptability, burden and satisfaction with the assigned physical therapy modality between the two arms based on patient satisfaction questionnaire administered at the end of treatment.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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Loma Linda, California, United States, 92354
- Loma Linda Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Arm 1: Investigational INF
Intraneural Facilitation (INF) treatment is an effective way to restore blood flow to damaged nerves as neuropathy is strongly impacted by reduced blood flow.
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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.
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Other: Arm 2: Standardized muscle stretching and strengthen
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
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subjects will receive a standardized program of muscle stretching and strengthening exercise under the supervision of treating physical therapist.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Descriptive Statistics to measure the degree of peripheral neuropathy in the two arms based on the PQAS score.
Time Frame: upto 3 months post completion of assigned treatment
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The 20 item PQAS measures self reported aspects of nociceptive and neuropathic pain (intensity, sensation, depth, location) on a scale of 0 to 10.
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upto 3 months post completion of assigned treatment
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Descriptive Statistics to measure the degree of distress in the two arms based on NCCN- DT
Time Frame: upto 3 months post completion of assigned treatment
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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.
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upto 3 months post completion of assigned treatment
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Descriptive Statistics to measure the degree of peripheral neuropathy in the two arms based on MSNI scores
Time Frame: upto 3 months post completion of assigned treatment
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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
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upto 3 months post completion of assigned treatment
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Descriptive Statistics to measure the degree of peripheral neuropathy in the two arms based on CTCAE grading
Time Frame: upto 3 months post completion of assigned treatment
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The CTCAE measures peripheral sensory neuropathy on a scale of 1=asymptomatic to 5=death as measured by the treating physician
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upto 3 months post completion of assigned treatment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measure the peak systolic velocity on ultrasound imaging in the popliteal and posterior tibia artery in the two arms.
Time Frame: upto 3 months post completion of assigned treatment
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Ultrasound imaging will be administered before and after treatment on the measurement days for subjects in both Arm 1 and Arm 2
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upto 3 months post completion of assigned treatment
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Measure the rate of premature chemotherapy discontinuation due to peripheral neuropathy by treatment group
Time Frame: upto 3 months post completion of assigned treatment
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The completion and premature discontinuation rates due to peripheral neuropathy for each subject will be counted for each Arm.
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upto 3 months post completion of assigned treatment
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Measure the rate of dose reductions in chemotherapy due to peripheral neuropathy by treatment group
Time Frame: upto 3 months post completion of assigned treatment
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The dose reductions in chemotherapy due to peripheral neuropathy for each subject will be measured for each Arm.
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upto 3 months post completion of assigned treatment
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Questionnaire to survey patients on acceptability, satisfaction and burden of treatment
Time Frame: upto 3 months post completion of assigned treatment.
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A written survey of 10 questions regarding subject acceptance, burden and satisfaction will be administered to each subject in both Arms at the end of treatment.
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upto 3 months post completion of assigned treatment.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Gayathri Nagaraj, MD, Loma Linda University Medical Center
- Principal Investigator: Ellen D'Errico, PHD, Loma Linda University School of Nursing
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5170197
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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