Hand Therapy Intervention Versus Traditional Occupational Therapy to Prevent Chemotherapy Induced Peripheral Neuropathy
- Conditions
- Adenocarcinoma of Pancreas
- Interventions
- Other: Hand Therapy Until CIPN
- Registration Number
- NCT05374876
- Lead Sponsor
- HonorHealth Research Institute
- Brief Summary
A pilot randomized feasibility trial with a blinded evaluator.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 49
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Investigational hand therapy (IHT)] intervention targeting the nervous system Hand Therapy Until CIPN - Traditional occupational therapy intervention targeting compensatory strategies (TOT) Hand Therapy Until CIPN -
- Primary Outcome Measures
Name Time Method Change in Cutaneous Sensation time of consent until the time of onset of CIPN of the hands or through 84 days of treatment measured by CTCAE Version 4
- Secondary Outcome Measures
Name Time Method Change in median nerve tolerance at the right and left volar wrist time of consent until the time of onset of CIPN of the hands or through 84 days of treatment measured by Phalen's test
Indication of irritability of the median and ulnar nerve at the right and left wrist time of consent until the time of onset of CIPN of the hands or through 84 days of treatment measured by Tinel test
Change in pressure threshold sensation time of consent until the time of onset of CIPN of the hands or through 84 days of treatment measured by monofilament test
Change in peripheral nerve tolerance at the thoracic level of the right and left arm time of consent until the time of onset of CIPN of the hands or through 84 days of treatment measured by elevated arm stress test
Change in ulnar nerve tolerance at the right and left elbow time of consent until the time of onset of CIPN of the hands or through 84 days of treatment measured by elbow flexion test
Change in pain time of consent until the time of onset of CIPN of the hands or through 84 days of treatment measured by visual analog scale
Change in moving touch sensation time of consent until the time of onset of CIPN of the hands or through 84 days of treatment measured by TEN test
Change in innervation density time of consent until the time of onset of CIPN of the hands or through 84 days of treatment measured by Two Point Discrimination Test
Trial Locations
- Locations (1)
HonorHealth Research Institute
🇺🇸Scottsdale, Arizona, United States