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

Primary Purpose

Adenocarcinoma of Pancreas

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hand Therapy Until CIPN
Sponsored by
HonorHealth Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Adenocarcinoma of Pancreas

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • HonorHealth Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Investigational hand therapy (IHT)] intervention targeting the nervous system

Traditional occupational therapy intervention targeting compensatory strategies (TOT)

Arm Description

Outcomes

Primary Outcome Measures

Change in Cutaneous Sensation
measured by CTCAE Version 4

Secondary Outcome Measures

Change in pain
measured by visual analog scale
Change in moving touch sensation
measured by TEN test
Change in innervation density
measured by Two Point Discrimination Test
Change in pressure threshold sensation
measured by monofilament test
Change in peripheral nerve tolerance at the thoracic level of the right and left arm
measured by elevated arm stress test
Change in median nerve tolerance at the right and left volar wrist
measured by Phalen's test
Change in ulnar nerve tolerance at the right and left elbow
measured by elbow flexion test
Indication of irritability of the median and ulnar nerve at the right and left wrist
measured by Tinel test

Full Information

First Posted
October 29, 2021
Last Updated
May 10, 2022
Sponsor
HonorHealth Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05374876
Brief Title
Hand Therapy Intervention Versus Traditional Occupational Therapy to Prevent Chemotherapy Induced Peripheral Neuropathy
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
May 13, 2016 (Actual)
Primary Completion Date
September 15, 2020 (Actual)
Study Completion Date
September 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HonorHealth Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenocarcinoma of Pancreas

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Investigational hand therapy (IHT)] intervention targeting the nervous system
Arm Type
Other
Arm Title
Traditional occupational therapy intervention targeting compensatory strategies (TOT)
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Hand Therapy Until CIPN
Intervention Description
Patient will participate until the time of onset of CIPN of the hands or through 84 days of treatment if no symptoms of CIPN.
Primary Outcome Measure Information:
Title
Change in Cutaneous Sensation
Description
measured by CTCAE Version 4
Time Frame
time of consent until the time of onset of CIPN of the hands or through 84 days of treatment
Secondary Outcome Measure Information:
Title
Change in pain
Description
measured by visual analog scale
Time Frame
time of consent until the time of onset of CIPN of the hands or through 84 days of treatment
Title
Change in moving touch sensation
Description
measured by TEN test
Time Frame
time of consent until the time of onset of CIPN of the hands or through 84 days of treatment
Title
Change in innervation density
Description
measured by Two Point Discrimination Test
Time Frame
time of consent until the time of onset of CIPN of the hands or through 84 days of treatment
Title
Change in pressure threshold sensation
Description
measured by monofilament test
Time Frame
time of consent until the time of onset of CIPN of the hands or through 84 days of treatment
Title
Change in peripheral nerve tolerance at the thoracic level of the right and left arm
Description
measured by elevated arm stress test
Time Frame
time of consent until the time of onset of CIPN of the hands or through 84 days of treatment
Title
Change in median nerve tolerance at the right and left volar wrist
Description
measured by Phalen's test
Time Frame
time of consent until the time of onset of CIPN of the hands or through 84 days of treatment
Title
Change in ulnar nerve tolerance at the right and left elbow
Description
measured by elbow flexion test
Time Frame
time of consent until the time of onset of CIPN of the hands or through 84 days of treatment
Title
Indication of irritability of the median and ulnar nerve at the right and left wrist
Description
measured by Tinel test
Time Frame
time of consent until the time of onset of CIPN of the hands or through 84 days of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gayle Jameson
Organizational Affiliation
HonorHealth Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
HonorHealth Research Institute
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Journal articles

Learn more about this trial

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

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