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Completed

NCT Number: NCT05374876

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

A pilot randomized feasibility trial with a blinded evaluator.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

HonorHealth Research Institute

Scottsdale, Arizona, 85258, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with adenocarcinoma of the pancreas who will receive chemotherapy with albumin bound paclitaxel plus gemcitabine containing combination
  • Patients who have no prior evidence of peripheral neuropathy of the hands
  • Age 18 years or older
  • Able to sit for minimum of 30 minutes for hand therapy sessions

Exclusion criteria

  • Patients who have received at least one dose of chemotherapy with albumin bound paclitaxel plus gemcitabine during the past 6 months
  • Patients taking duloxetine or gabapentin
  • History of peripheral neuropathy of the hands due to chemotherapy, diabetes, or other causes
  • Inability to sit for minimum of 30 minutes
  • Documented cognitive problems limiting ability to participate in hand therapy

Treatment and study plan

Hand Therapy Until CIPN

Other

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)

Primary outcomes

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

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

    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.

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

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

    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.

Secondary outcomes

  1. Average Pain Score for Hand Pain

    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

    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.

  2. Average Motor Function and Symptoms [QuickDASH Score]

    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

    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.

  3. 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)]

    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

    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.

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

    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

    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.

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

    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

    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.

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

    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

    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.

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

    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

    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.

Sponsors and collaborators

Lead sponsor

HonorHealth Research Institute

Other

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2020
Study completion
2021
First posted
May 16, 2022
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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