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

• Sponsor: HonorHealth Research Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT05374876
• Collaborator: (none)
• Enrollment: 49
• Location: 1
• Arms: 2
• Actual Duration (Months): 64.6
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

A pilot randomized feasibility trial with a blinded evaluator.

Condition or Disease	Intervention/Treatment	Phase
Adenocarcinoma of Pancreas	Other: Hand Therapy Until CIPN	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 49 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• 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
• Actual Study Start Date: May 13, 2016
• Actual Primary Completion Date: Sep 15, 2020
• Actual Study Completion Date: Sep 30, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

2. 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

3. 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

4. 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

5. 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

6. 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

7. 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

8. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	HonorHealth Research Institute	Scottsdale	Arizona	United States	85258

Sponsors and Collaborators

• HonorHealth Research Institute

Investigators

• Principal Investigator: Gayle Jameson, HonorHealth Research Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: HonorHealth Research Institute
• ClinicalTrials.gov Identifier: NCT05374876
• Other Study ID Numbers: AX-CL-PANC-PI-003347
• First Posted: May 16, 2022
• Last Update Posted: May 16, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Peripheral Nervous System Diseases

Study Results

No Results Posted as of May 16, 2022