Hand Therapy Intervention Versus Traditional Occupational Therapy to Prevent Chemotherapy Induced Peripheral Neuropathy

Study Overview
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Brief Summary
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A pilot randomized feasibility trial with a blinded evaluator.

Detailed Description
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Chemotherapy-induced peripheral neuropathy (CIPN) has a dose limiting effect which can greatly affect quality of life and often limits the amount of treatment patients can receive in treating their cancer. In the discipline of hand therapy, there is a science-based body of knowledge with effective protocols to treat neuropathies associated with injury and disease. These interventions have not been explored on patients with CIPN.

Official Title
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Pilot Randomized Feasibility Trial Comparing Investigational Hand Therapy Intervention to Traditional Occupational Therapy Intervention to Prevent Chemotherapy-Induced Peripheral Neuropathy of the Hands in Patients Receiving Albumin Bound Paclitaxel + Gemcitabine Containing Combination Chemotherapy

Conditions
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Adenocarcinoma of Pancreas

Intervention / Treatment
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* Other: Hand Therapy Until CIPN


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with adenocarcinoma of the pancreas who will receive chemotherapy with albumin bound paclitaxel plus gemcitabine containing combination Patients who have no prior evidence of peripheral neuropathy of the hands Age 18 years or older Able to sit for minimum of 30 minutes for hand therapy sessions Exclusion Criteria: Patients who have received at least one dose of chemotherapy with albumin bound paclitaxel plus gemcitabine during the past 6 months Patients taking duloxetine or gabapentin History of peripheral neuropathy of the hands due to chemotherapy, diabetes, or other causes Inability to sit for minimum of 30 minutes Documented cognitive problems limiting ability to participate in hand therapy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Investigational hand therapy (IHT)] intervention targeting the nervous system<br> | Other: Hand Therapy Until CIPN<br>* Patient will participate until the time of onset of CIPN of the hands or through 84 days of treatment if no symptoms of CIPN.<br>|
| Other: Traditional occupational therapy intervention targeting compensatory strategies (TOT)<br> | Other: Hand Therapy Until CIPN<br>* Patient will participate until the time of onset of CIPN of the hands or through 84 days of treatment if no symptoms of CIPN.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Cutaneous Sensation | measured by CTCAE Version 4 | time of consent until the time of onset of CIPN of the hands or through 84 days of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain | measured by visual analog scale | time of consent until the time of onset of CIPN of the hands or through 84 days of treatment | 
| Change in moving touch sensation | measured by TEN test | time of consent until the time of onset of CIPN of the hands or through 84 days of treatment | 
| Change in innervation density | measured by Two Point Discrimination Test | time of consent until the time of onset of CIPN of the hands or through 84 days of treatment | 
| Change in pressure threshold sensation | measured by monofilament test | time of consent until the time of onset of CIPN of the hands or through 84 days of treatment | 
| Change in peripheral nerve tolerance at the thoracic level of the right and left arm | measured by elevated arm stress test | time of consent until the time of onset of CIPN of the hands or through 84 days of treatment | 
| Change in median nerve tolerance at the right and left volar wrist | measured by Phalen's test | time of consent until the time of onset of CIPN of the hands or through 84 days of treatment | 
| Change in ulnar nerve tolerance at the right and left elbow | measured by elbow flexion test | time of consent until the time of onset of CIPN of the hands or through 84 days of treatment | 
| Indication of irritability of the median and ulnar nerve at the right and left wrist | measured by Tinel test | time of consent until the time of onset of CIPN of the hands or through 84 days of treatment |