Chemotherapy Induced Peripheral Neuropathy (CIPN)

Chemotherapy Induced Peripheral Neuropathy (CIPN): A Pilot Study of Intraneural Facilitation for Managing Chemotherapy-Induced Peripheral Neuropathy

Sponsors

Lead Sponsor: Loma Linda University

Source 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.

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.

Overall Status Recruiting
Start Date September 28, 2017
Completion Date May 25, 2021
Primary Completion Date May 25, 2021
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Descriptive Statistics to measure the degree of peripheral neuropathy in the two arms based on the PQAS score. upto 3 months post completion of assigned treatment
Descriptive Statistics to measure the degree of distress in the two arms based on NCCN- DT 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 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 upto 3 months post completion of assigned treatment
Secondary Outcome
Measure Time Frame
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.
Enrollment 40
Condition
Intervention

Intervention Type: Other

Intervention Name: Arm 1: Investigational INF

Description: 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 Group Label: Arm 1: Investigational INF

Intervention Type: Other

Intervention Name: Arm 2: standardized muscle stretching and strength

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

Arm Group Label: Arm 2: Standardized muscle stretching and strengthen

Eligibility

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).

- 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

Gender: Female

Gender Based: Yes

Gender Description: Women aged ≥ 18 years at signing of informed consent

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Overall Contact

Last Name: Lorena Garcia

Phone: 9095584050

Email: [email protected]

Location
Facility: Status: Contact: Contact Backup: Loma Linda Medical Center Gayathri Nagaraj, MD 909-558-4050 [email protected]
Location Countries

United States

Verification Date

August 2020

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Loma Linda University

Investigator Full Name: Gayathri Nagaraj

Investigator Title: Primary Investigator / Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Arm 1: Investigational INF

Type: Experimental

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

Label: Arm 2: Standardized muscle stretching and strengthen

Type: Other

Description: 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

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Prevention

Masking: None (Open Label)

Source: ClinicalTrials.gov