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

HonorHealth Research Institute

Status: Completed

Conditions: Adenocarcinoma of Pancreas

Treatments: Other: Hand Therapy Until CIPN

Study type: Interventional

Funder types: Other

Identifiers

NCT05374876

AX-CL-PANC-PI-003347

Details and patient eligibility

About

A pilot randomized feasibility trial with a blinded evaluator.

Full 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.

Enrollment: 49 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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49 participants in 2 patient groups

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

Other group

Treatment:

Other: Hand Therapy Until CIPN

Traditional occupational therapy intervention targeting compensatory strategies (TOT)

Other group

Treatment:

Other: Hand Therapy Until CIPN