HonorHealth Research Institute
Scottsdale, Arizona, 85258, United States
NCT Number: NCT05374876
A pilot randomized feasibility trial with a blinded evaluator.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Scottsdale, Arizona, 85258, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 intervention targeting compensatory strategies (TOT)
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.
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.
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.
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.
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.
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.
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.
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.
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.
HonorHealth Research Institute
Other
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
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