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Chemotherapy Induced Peripheral Neuropathy (CIPN)

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ClinicalTrials.gov Identifier: NCT03272919
Recruitment Status : Recruiting
First Posted : September 6, 2017
Last Update Posted : August 24, 2018
Sponsor:
Information provided by (Responsible Party):
Gayathri Nagaraj, Loma Linda University

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.

Condition or disease Intervention/treatment Phase
Chemotherapy-induced Peripheral Neuropathy Other: Arm 1: Investigational INF Other: Arm 2: standardized muscle stretching and strength Not Applicable

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) 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 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 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 : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Chemotherapy Induced Peripheral Neuropathy (CIPN): A Pilot Study of Intraneural Facilitation for Managing Chemotherapy-Induced Peripheral Neuropathy
Actual Study Start Date : September 28, 2017
Estimated Primary Completion Date : May 31, 2020
Estimated Study Completion Date : May 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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. 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.

INF treatment will be administered twice a week for six weeks under the supervision of treating physical therapist.

Other: Arm 1: Investigational INF
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 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
Other: Arm 2: standardized muscle stretching and strength
subjects will receive a standardized program of muscle stretching and strengthening exercise under the supervision of treating physical therapist.




Primary Outcome Measures :
  1. 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 ]
    The 20 item PQAS measures self reported aspects of nociceptive and neuropathic pain (intensity, sensation, depth, location) on a scale of 0 to 10.

  2. 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 ]
    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.

  3. 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 ]
    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

  4. 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 ]
    The CTCAE measures peripheral sensory neuropathy on a scale of 1=asymptomatic to 5=death as measured by the treating physician


Secondary Outcome Measures :
  1. 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 ]
    Ultrasound imaging will be administered before and after treatment on the measurement days for subjects in both Arm 1 and Arm 2

  2. Measure the rate of premature chemotherapy discontinuation due to peripheral neuropathy by treatment group [ Time Frame: upto 3 months post completion of assigned treatment ]
    The completion and premature discontinuation rates due to peripheral neuropathy for each subject will be counted for each Arm.

  3. 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 ]
    The dose reductions in chemotherapy due to peripheral neuropathy for each subject will be measured for each Arm.

  4. Questionnaire to survey patients on acceptability, satisfaction and burden of treatment [ Time Frame: upto 3 months post completion of assigned treatment. ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Women aged ≥ 18 years at signing of informed consent
Accepts Healthy Volunteers:   No
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).
  • May receive planned standard chemotherapy regimen in the adjuvant or neoadjuvant setting.
  • 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.
  • Able to read and comprehend English and Spanish.

Exclusion Criteria:

  • Male
  • Preexisting peripheral neuropathy.
  • Previous exposure to any of the implicated chemotherapy agents (platinum-based compounds, vinca alkaloids and/or taxanes.)
  • 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
  • Obesity > BMI 30 or any physical or neurological disability that would preclude patients from participating in physical therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03272919


Contacts
Contact: Darla Boadway 9095584050 dboadway@llu.edu
Contact: Lorena Garcia 9095584050

Locations
United States, California
Loma Linda Medical Center Recruiting
Loma Linda, California, United States, 92354
Contact: Nahidh Hasaniya, MD,PhD    909-558-4354    nhasaniya@llu.edu   
Contact: Vanessa L Ayer Miller, MS    9095584355    vayermiller@llu.edu   
Sponsors and Collaborators
Loma Linda University
Investigators
Principal Investigator: Gayathri Nagaraj, MD Loma Linda University Medical Center
Principal Investigator: Ellen D'Errico, PHD Loma Linda University School of Nursing

Responsible Party: Gayathri Nagaraj, Primary Investigator / Sponsor, Loma Linda University
ClinicalTrials.gov Identifier: NCT03272919     History of Changes
Other Study ID Numbers: 5170197
First Posted: September 6, 2017    Key Record Dates
Last Update Posted: August 24, 2018
Last Verified: August 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Gayathri Nagaraj, Loma Linda University:
Breast Cancer, Peripheral neuropathy, Taxol, carboplatin

Additional relevant MeSH terms:
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases