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

Adenocarcinoma of Pancreas Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05374876
• Other study ID #: AX-CL-PANC-PI-003347
• Status: Completed
• Phase: N/A
• Start date: May 13, 2016
• Est. completion date: September 30, 2021

Study information

• Verified date: May 2022
• Source: HonorHealth Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A pilot randomized feasibility trial with a blinded evaluator.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: September 30, 2021
• Est. primary completion date: September 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma of Pancreas
• Peripheral Nervous System Diseases

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	HonorHealth Research Institute	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
HonorHealth Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in pain	measured by visual analog scale	time of consent until the time of onset of CIPN of the hands or through 84 days of treatment
Secondary	Change in moving touch sensation	measured by TEN test	time of consent until the time of onset of CIPN of the hands or through 84 days of treatment
Secondary	Change in innervation density	measured by Two Point Discrimination Test	time of consent until the time of onset of CIPN of the hands or through 84 days of treatment
Secondary	Change in pressure threshold sensation	measured by monofilament test	time of consent until the time of onset of CIPN of the hands or through 84 days of treatment
Secondary	Change in peripheral nerve tolerance at the thoracic level of the right and left arm	measured by elevated arm stress test	time of consent until the time of onset of CIPN of the hands or through 84 days of treatment
Secondary	Change in median nerve tolerance at the right and left volar wrist	measured by Phalen's test	time of consent until the time of onset of CIPN of the hands or through 84 days of treatment
Secondary	Change in ulnar nerve tolerance at the right and left elbow	measured by elbow flexion test	time of consent until the time of onset of CIPN of the hands or through 84 days of treatment
Secondary	Indication of irritability of the median and ulnar nerve at the right and left wrist	measured by Tinel test	time of consent until the time of onset of CIPN of the hands or through 84 days of treatment