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

HonorHealth Research Institute49 enrolled

Overview

A pilot randomized feasibility trial with a blinded evaluator.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Adenocarcinoma of Pancreas

Interventions

Hand Therapy Until CIPNOTHER

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 (TOT)OTHER

Traditional occupational therapy intervention targeting compensatory strategies (TOT)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

HonorHealth Research Institute

Scottsdale, Arizona, United States

Outcomes

Primary Outcomes

Number of Participants With Chemotherapy-Induced Peripheral Neuropathy (CIPN)

The number of participants reported to have chemotherapy-induced peripheral neuropathy (CIPN) as measured by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.

Time frame: Time of consent until the time of onset of CIPN of the hands or through 84 days of treatment

Mean Time-to-Event for Chemotherapy-Induced Peripheral Neuropathy (CIPN) Onset

The mean time-to-event for chemotherapy-induced peripheral neuropathy CIPN) onset, as measured by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, is reported here. The analysis was produced using the Kaplan-Meier method.

Time frame: Time of consent until the time of onset of CIPN of the hands or through 84 days of treatment

Secondary Outcomes

Average Pain Score for Hand Pain

The average pain score for hand pain among participants. Participants were tested at 5 visits throughout the study, and the 5 visits were averaged to produce a single score per participant. The average of the single score among participants is reported here. Hand pain was measured using the Visual Analog Scale (VAS) to measure pain intensity. This scale consists of a 10-cm horizontal line with "no pain" (score = 0 cm) on the left and "worst pain imaginable" (score = 10 cm) on the right. Participants mark their pain on the line, and the score is measured in centimeters.

Time frame: Visit 1: between consent and day 1 of chemotherapy; Visit 2: between days 8 and 15 of chemotherapy; Visit 3: between days 22 and 29 of chemotherapy; Visit 4: between days 50 and 57 of chemotherapy; Visit 5: at end of study

Average Motor Function and Symptoms [QuickDASH Score]

Motor function and symptoms among participants were measured using the QuickDASH questionnaire. This is an 11-item questionnaire used to monitor physical function and symptoms over time in people with upper-extremity musculoskeletal disorders. QuickDASH outputs a total functionality score ranging from 0 (no disability) to 100 (most severe disability). Questions related to daily activities, interference of social activities, limitations to work, and severity of symptoms are scored on a 5-point Likert scale (1 - no difficulty, 2 - mild difficulty, 3 - moderate difficulty, 4 - severe difficulty, 5 - unable). Responses are input into the following mathematical formula to output the total functionality score: \[(Sum of n responses / n - 1) \* 25\]. Scores of 0 - 30 are interpreted as mild to no disability, 31 - 60 moderate disability, and 61 to 100 as severe disability.

Data from ClinicalTrials.gov

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Number of Participants With Positive or Negative Peripheral Nerve Tolerance at the Thoracic Level of the Right and Left Arm [Elevated Arm Stress Test (EAST)]

The number of participants with positive or negative peripheral nerve tolerance is reported here for both right and left arms as measured by the elevated arm stress test (EAST). EAST is a clinical provocation maneuver and is performed by holding the arms in a position of 90 degrees of abduction and external rotation ("stick-up position"). The patient then opens and closes the hands slowly for a period of 3 minutes. Reproduction of symptoms in the entire extremity or rapid fatigue of the extremity constitutes a positive test result. No reproduction of symptoms or rapid fatigue constitutes a negative result. Patients with thoracic outlet syndrome (TOS) typically have a positive test.

Number of Participants With Positive or Negative Median Nerve Irritation at the Right and Left Wrist [Phalen's Test]

The number of participants with positive or negative median nerve irritation at the right and left wrist as measured by Phalen's test. This test is a neurological physical exam that involves passive flexion of the wrist for 15 to 60 seconds and reporting numbness/tingling. A positive test produces numbness and tingling in the distribution of the median nerve, while a negative test produces no numbness or tingling.

Number of Participants With Positive or Negative Ulnar Nerve Compression at the Right and Left Arm [Elbow Flexion Test]

The number of participants with positive or negative ulnar nerve compression at the right and left arm as measured by the elbow flexion test. With the shoulder in neutral position, manual pressure is applied to the ulnar nerve in the cubital tunnel as the elbow is placed in terminal flexion with the forearm supported in supination. The wrist is maintained in a neutral position. The position is held for 60 seconds. A positive test reports numbness, tingling, or shooting pain in the forearm, hand, or fingers. A negative test reports no numbness, tingling, or shooting pain in the forearm, hand, or fingers.

Number of Participants With Positive or Negative Ulnar Nerve Injury at the Right and Left Cubital Tunnel [Tinel's Test]

The number of participants with positive or negative ulnar nerve injury at the right and left cubital tunnel as measured by Tinel's test. Tinel's test is a neurological physical exam administered as follows: with placing the patient's elbow fully flexed and the wrist held in neutral position, the examiner taps over the ulnar nerve at the cubital tunnel. A positive result causes tingling or pain, while a negative result causes no tingling or pain.

Number of Participants With Positive or Negative Ulnar Nerve Injury at the Right and Left Volar Wrist [Tinel's Test]

The number of participants with positive or negative ulnar nerve injury at the right and left volar wrist as measured by Tinel's test. Tinel's test is a neurological physical exam administered as follows: with placing the patient's elbow fully flexed and the wrist held in neutral position, the examiner taps over the ulnar nerve at the volar wrist. A positive result causes tingling or pain, while a negative result causes no tingling or pain.