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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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05374876
Enrollment
49
Registered
2022-05-16
Start date
2016-05-13
Completion date
2021-09-30
Last updated
2026-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adenocarcinoma of Pancreas

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.

Interventions

OTHERHand 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.

OTHERTraditional Occupational Therapy (TOT)

Traditional occupational therapy intervention targeting compensatory strategies (TOT)

Sponsors

HonorHealth Research Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORGayle Jameson

HonorHealth Research Institute

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 9, 2026