Ignite Creation Date:
2024-05-06 @ 10:29 AM
Last Modification Date:
2024-10-26 @ 12:31 PM
Study NCT ID:
NCT03272919
Status:
COMPLETED
Last Update Posted:
2023-05-10
First Post:
2017-08-08
Brief Title:
Chemotherapy Induced Peripheral Neuropathy CIPN
Sponsor:
Loma Linda University
Organization:
Loma Linda University
Study Overview
Official Title:
Chemotherapy Induced Peripheral Neuropathy CIPN A Pilot Study of Intraneural Facilitation for Managing Chemotherapy-Induced Peripheral Neuropathy
Status:
COMPLETED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 gaitbalance problems and difficulty with fine motor skills of the hands and fingersTo date there are no preventive modalities to mitigate CIPN developmentWhen CIPN becomes intolerable optimal doses of chemotherapy have to be reduced or discontinued which may affect a patients 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
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 andor 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 andor 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None