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

NCT ID: NCT05374876

Last Updated: 2022-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-13
• Study Completion Date: 2021-09-30

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.

Conditions

Adenocarcinoma of Pancreas

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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

Group Type: OTHER

Hand Therapy Until CIPN

Intervention Type: OTHER

Patient will participate until the time of onset of CIPN of the hands or through 84 days of treatment if no symptoms of CIPN.

Traditional occupational therapy intervention targeting compensatory strategies (TOT)

Group Type: OTHER

Hand Therapy Until CIPN

Intervention Type: OTHER

Patient will participate until the time of onset of CIPN of the hands or through 84 days of treatment if no symptoms of CIPN.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

HonorHealth Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gayle Jameson

Role: PRINCIPAL_INVESTIGATOR

HonorHealth Research Institute

Locations

HonorHealth Research Institute

Scottsdale, Arizona, United States

Countries

United States

References

Jameson GS, Cooper C, Snyder C, Buchanan SM, Strelish T, Shearon T, Von Hoff DD, Bay C, Hull L, Kaatz LA, Borazanci EH. Hand therapy interventions for the prevention of chemotherapy-induced peripheral neuropathy of the hands in patients with pancreatic cancer. Oncologist. 2024 Dec 6;29(12):1095-e1778. doi: 10.1093/oncolo/oyae285.

Reference Type: DERIVED

PMID: 39436905 (View on PubMed)

Other Identifiers

AX-CL-PANC-PI-003347

Identifier Type: -

Identifier Source: org_study_id