Chemotherapy Induced Peripheral Neuropathy (CIPN)
| Status: | Recruiting |
|---|---|
| Conditions: | Cancer, Neurology |
| Therapuetic Areas: | Neurology, Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/3/2019 |
| Start Date: | September 28, 2017 |
| End Date: | May 31, 2020 |
| Contact: | Lorena Garcia |
| Email: | lcgarcia@llu.edu |
| Phone: | 9095584050 |
Chemotherapy Induced Peripheral Neuropathy (CIPN): A Pilot Study of Intraneural Facilitation for Managing Chemotherapy-Induced Peripheral Neuropathy
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.
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.
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.
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.
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
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