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
1 other identifier
interventional
49
1 country
1
Brief Summary
A pilot randomized feasibility trial with a blinded evaluator.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 13, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 15, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2021
CompletedFirst Submitted
Initial submission to the registry
October 29, 2021
CompletedFirst Posted
Study publicly available on registry
May 16, 2022
CompletedResults Posted
Study results publicly available
July 8, 2026
CompletedJuly 8, 2026
April 1, 2026
4.3 years
October 29, 2021
April 16, 2026
July 7, 2026
Conditions
Study Arms (2)
Investigational hand therapy (IHT)] intervention targeting the nervous system
EXPERIMENTALTraditional occupational therapy intervention targeting compensatory strategies (TOT)
OTHERInterventions
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)
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
HonorHealth Research Institute
Scottsdale, Arizona, 85258, United States
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: 39436905DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Gayle Jameson
HonorHealth Research Institute
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
July 8, 2026
Results First Posted
July 8, 2026
Record last verified: 2026-04