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

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

A pilot randomized feasibility trial with a blinded evaluator.

Study Overview

• Status: Completed
• Conditions: Adenocarcinoma of Pancreas
• Intervention / Treatment: Other: Hand Therapy Until CIPN

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.

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85258
      • HonorHealth Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients with adenocarcinoma of the pancreas who will receive chemotherapy with albumin bound paclitaxel plus gemcitabine containing combination
2. Patients who have no prior evidence of peripheral neuropathy of the hands
3. Age 18 years or older
4. Able to sit for minimum of 30 minutes for hand therapy sessions

Exclusion Criteria:

1. Patients who have received at least one dose of chemotherapy with albumin bound paclitaxel plus gemcitabine during the past 6 months
2. Patients taking duloxetine or gabapentin
3. History of peripheral neuropathy of the hands due to chemotherapy, diabetes, or other causes
4. Inability to sit for minimum of 30 minutes
5. Documented cognitive problems limiting ability to participate in hand therapy

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: HonorHealth Research Institute
• Investigators: Principal Investigator: Gayle Jameson, HonorHealth Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2016
• Primary Completion (Actual): September 15, 2020
• Study Completion (Actual): September 30, 2021

Study Registration Dates

• First Submitted: October 29, 2021
• First Submitted That Met QC Criteria: May 10, 2022
• First Posted (Actual): May 16, 2022

Study Record Updates

• Last Update Posted (Actual): May 16, 2022
• Last Update Submitted That Met QC Criteria: May 10, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases
• Other Study ID Numbers: AX-CL-PANC-PI-003347

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Journal articles

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No