Clinical trial NCT05374876: Hand Therapy Intervention Versus Traditional Occupational Therapy to Prevent Chemotherapy Induced Peripheral Neuropathy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adenocarcinoma of Pancreas
Lead sponsor: HonorHealth Research Institute
Sponsor class: OTHER
First posted: 2022-05-16
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Cutaneous Sensation
timeFrame: time of consent until the time of onset of CIPN of the hands or through 84 days of treatment
Secondary outcomes:
measure: Change in pain
timeFrame: time of consent until the time of onset of CIPN of the hands or through 84 days of treatment
measure: Change in moving touch sensation
timeFrame: time of consent until the time of onset of CIPN of the hands or through 84 days of treatment
measure: Change in innervation density
timeFrame: time of consent until the time of onset of CIPN of the hands or through 84 days of treatment
measure: Change in pressure threshold sensation
timeFrame: time of consent until the time of onset of CIPN of the hands or through 84 days of treatment
measure: Change in peripheral nerve tolerance at the thoracic level of the right and left arm
timeFrame: time of consent until the time of onset of CIPN of the hands or through 84 days of treatment
measure: Change in median nerve tolerance at the right and left volar wrist
timeFrame: time of consent until the time of onset of CIPN of the hands or through 84 days of treatment
measure: Change in ulnar nerve tolerance at the right and left elbow
timeFrame: time of consent until the time of onset of CIPN of the hands or through 84 days of treatment
measure: Indication of irritability of the median and ulnar nerve at the right and left wrist
timeFrame: time of consent until the time of onset of CIPN of the hands or through 84 days of treatment
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: HonorHealth Research Institute
state: Arizona
Study officials:
affiliation: HonorHealth Research Institute
name: Gayle Jameson
role: PRINCIPAL_INVESTIGATOR
References: