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

NCT05374876 | Completed

• 1 other identifier: AX-CL-PANC-PI-003347
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

A pilot randomized feasibility trial with a blinded evaluator.

Conditions

Adenocarcinoma of Pancreas

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Change in pain

  time of consent until the time of onset of CIPN of the hands or through 84 days of treatment

• Change in moving touch sensation

  time of consent until the time of onset of CIPN of the hands or through 84 days of treatment

• Change in innervation density

  time of consent until the time of onset of CIPN of the hands or through 84 days of treatment

• Change in pressure threshold sensation

  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

  time of consent until the time of onset of CIPN of the hands or through 84 days of treatment

Study Arms (2)

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

OTHER

Other: Hand Therapy Until CIPN

Traditional occupational therapy intervention targeting compensatory strategies (TOT)

OTHER

Other: Hand Therapy Until CIPN

Interventions

Hand Therapy Until CIPN 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.

Investigational hand therapy (IHT)] intervention targeting the nervous system; Traditional occupational therapy intervention targeting compensatory strategies (TOT)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• HonorHealth Research Institute: lead

Study Sites (1)

HonorHealth Research Institute

Scottsdale, Arizona, 85258, United States

Location

Related Publications (1)

• 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.

  PMID: 39436905 DERIVED

Study Officials

• Gayle Jameson

  HonorHealth Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2021
• First Posted: May 16, 2022
• Study Start: May 13, 2016
• Primary Completion: September 15, 2020
• Study Completion: September 30, 2021
• Last Updated: May 16, 2022

Record last verified: 2022-05

Locations

US (1)