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

Brief summary public domain (ClinicalTrials.gov)

A pilot randomized feasibility trial with a blinded evaluator.

Detailed description public domain (ClinicalTrials.gov)

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.

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Number of Participants With Chemotherapy-Induced Peripheral Neuropathy (CIPN) [Time of consent until the time of onset of CIPN of the hands or through 84 days of treatment]. Count Of Participants, Participants. Investigational Hand Therapy (IHT) Intervention Targeting the Nervous System (n=21): 6; Traditional Occupational Therapy Intervention Targeting Compensatory Strategies (TOT) (n=19): 4. Analysis, Investigational Hand Therapy (IHT) Intervention Targeting the Nervous System vs Traditional Occupational Therapy Intervention Targeting Compensatory Strategies (TOT): p=0.721; Chi-squared; other.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Average Pain Score for Hand Pain [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]. Mean, VAS Pain Score (cm) (Standard Deviation). Investigational Hand Therapy (IHT)] Intervention Targeting the Nervous System (n=21): 0 (0); Traditional Occupational Therapy Intervention Targeting Compensatory Strategies (TOT) (n=19): 0 (0).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Average Motor Function and Symptoms [QuickDASH Score] [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]. Mean, QuickDASH Score (Standard Deviation). Visit 1: Investigational Hand Therapy (IHT) Intervention Targeting the Nervous System (n=21): 7.36 (10.31); Traditional Occupational Therapy Intervention Targeting Compensatory Strategies (TOT) (n=19): 7.06 (8.26). Visit 2: Investigational Hand Therapy (IHT) Intervention Targeting the Nervous System (n=21): 6.06 (9.27); Traditional Occupational Therapy Intervention Targeting Compensatory Strategies (TOT) (n=19): 7.49 (10.02). Visit 3: Investigational Hand Therapy (IHT) Intervention Targeting the Nervous System (n=21): 6.49 (9.43); Traditional Occupational Therapy Intervention Targeting Compensatory Strategies (TOT) (n=19): 6.10 (8.80). Visit 4: Investigational Hand Therapy (IHT) Intervention Targeting the Nervous System (n=21): 8.01 (10.51); Traditional Occupational Therapy Intervention Targeting Compensatory Strategies (TOT) (n=19): 7.84 (11.72). Visit 5: Investigational Hand Therapy (IHT) Intervention Targeting the Nervous System (n=21): 5.30 (7.95); Traditional Occupational Therapy Intervention Targeting Compensatory Strategies (TOT) (n=19): 6.20 (10.05).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

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)] [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]. Count Of Participants, Participants. Visit 1 - Right Arm / Negative: Investigational Hand Therapy (IHT)] Intervention Targeting the Nervous System (n=21): 20; Traditional Occupational Therapy Intervention Targeting Compensatory Strategies (TOT) (n=19): 19. Visit 1 - Right Arm / Positive: Investigational Hand Therapy (IHT)] Intervention Targeting the Nervous System (n=21): 0; Traditional Occupational Therapy Intervention Targeting Compensatory Strategies (TOT) (n=19): 0. Visit 2 - Right Arm / Negative: Investigational Hand Therapy (IHT)] Intervention Targeting the Nervous System (n=21): 21; Traditional Occupational Therapy Intervention Targeting Compensatory Strategies (TOT) (n=19): 19. Visit 2 - Right Arm / Positive: Investigational Hand Therapy (IHT)] Intervention Targeting the Nervous System (n=21): 0; Traditional Occupational Therapy Intervention Targeting Compensatory Strategies (TOT) (n=19): 0. Visit 3 - Right Arm / Negative: Investigational Hand Therapy (IHT)] Intervention Targeting the Nervous System (n=21): 20; Traditional Occupational Therapy Intervention Targeting Compensatory Strategies (TOT) (n=19): 19. Visit 3 - Right Arm / Positive: Investigational Hand Therapy (IHT)] Intervention Targeting the Nervous System (n=21): 1; Traditional Occupational Therapy Intervention Targeting Compensatory Strategies (TOT) (n=19): 0. Visit 4 - Right Arm / Negative: Investigational Hand Therapy (IHT)] Intervention Targeting the Nervous System (n=21): 18; Traditional Occupational Therapy Intervention Targeting Compensatory Strategies (TOT) (n=19): 18. Visit 4 - Right Arm / Positive: Investigational Hand Therapy (IHT)] Intervention Targeting the Nervous System (n=21): 0; Traditional Occupational Therapy Intervention Targeting Compensatory Strategies (TOT) (n=19): 0. Visit 5 - Right Arm / Negative: Investigational Hand Therapy (IHT)] Intervention Targeting the Nervous System (n=21): 15; Traditional Occupational Therapy Intervention Targeting Compensatory Strategies (TOT) (n=19): 17. Visit 5 - Right Arm / Positive: Investigational Hand Therapy (IHT)] Intervention Targeting the Nervous System (n=21): 0; Traditional Occupational Therapy Intervention Targeting Compensatory Strategies (TOT) (n=19): 0. Visit 1 - Left Arm / Negative: Investigational Hand Therapy (IHT)] Intervention Targeting the Nervous System (n=21): 21; Traditional Occupational Therapy Intervention Targeting Compensatory Strategies (TOT) (n=19): 19. Visit 1 - Left Arm / Positive: Investigational Hand Therapy (IHT)] Intervention Targeting the Nervous System (n=21): 0; Traditional Occupational Therapy Intervention Targ

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Number of Participants With Positive or Negative Median Nerve Irritation at the Right and Left Wrist [Phalen's Test] [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]. Count Of Participants, Participants. Visit 1 - Right Arm / Negative: Investigational Hand Therapy (IHT) Intervention Targeting the Nervous System (n=21): 21; Traditional Occupational Therapy Intervention Targeting Compensatory Strategies (TOT) (n=19): 19. Visit 1 - Right Arm / Positive: Investigational Hand Therapy (IHT) Intervention Targeting the Nervous System (n=21): 0; Traditional Occupational Therapy Intervention Targeting Compensatory Strategies (TOT) (n=19): 0. Visit 2 - Right Arm / Negative: Investigational Hand Therapy (IHT) Intervention Targeting the Nervous System (n=21): 21; Traditional Occupational Therapy Intervention Targeting Compensatory Strategies (TOT) (n=19): 19. Visit 2 - Right Arm / Positive: Investigational Hand Therapy (IHT) Intervention Targeting the Nervous System (n=21): 0; Traditional Occupational Therapy Intervention Targeting Compensatory Strategies (TOT) (n=19): 0. Visit 3 - Right Arm / Negative: Investigational Hand Therapy (IHT) Intervention Targeting the Nervous System (n=21): 20; Traditional Occupational Therapy Intervention Targeting Compensatory Strategies (TOT) (n=19): 19. Visit 3 - Right Arm / Positive: Investigational Hand Therapy (IHT) Intervention Targeting the Nervous System (n=21): 1; Traditional Occupational Therapy Intervention Targeting Compensatory Strategies (TOT) (n=19): 0. Visit 4 - Right Arm / Negative: Investigational Hand Therapy (IHT) Intervention Targeting the Nervous System (n=21): 17; Traditional Occupational Therapy Intervention Targeting Compensatory Strategies (TOT) (n=19): 18. Visit 4 - Right Arm / Positive: Investigational Hand Therapy (IHT) Intervention Targeting the Nervous System (n=21): 1; Traditional Occupational Therapy Intervention Targeting Compensatory Strategies (TOT) (n=19): 0. Visit 5 - Right Arm / Negative: Investigational Hand Therapy (IHT) Intervention Targeting the Nervous System (n=21): 15; Traditional Occupational Therapy Intervention Targeting Compensatory Strategies (TOT) (n=19): 15. Visit 5 - Right Arm / Positive: Investigational Hand Therapy (IHT) Intervention Targeting the Nervous System (n=21): 0; Traditional Occupational Therapy Intervention Targeting Compensatory Strategies (TOT) (n=19): 2. Visit 1 - Left Arm / Negative: Investigational Hand Therapy (IHT) Intervention Targeting the Nervous System (n=21): 21; Traditional Occupational Therapy Intervention Targeting Compensatory Strategies (TOT) (n=19): 19. Visit 1 - Left Arm / Positive: Investigational Hand Therapy (IHT) Intervention Targeting the Nervous System (n=21): 0; Traditional Occupational Therapy Intervention Targeting Compensatory Strategies (TOT) (n=19): 0. Visit

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Number of Participants With Positive or Negative Ulnar Nerve Compression at the Right and Left Arm [Elbow Flexion Test] [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]. Count Of Participants, Participants. Visit 1 - Right Arm / Negative: Investigational Hand Therapy (IHT) Intervention Targeting the Nervous System (n=21): 21; Traditional Occupational Therapy Intervention Targeting Compensatory Strategies (TOT) (n=19): 19. Visit 1 - Right Arm / Positive: Investigational Hand Therapy (IHT) Intervention Targeting the Nervous System (n=21): 0; Traditional Occupational Therapy Intervention Targeting Compensatory Strategies (TOT) (n=19): 0. Visit 2 - Right Arm / Negative: Investigational Hand Therapy (IHT) Intervention Targeting the Nervous System (n=21): 21; Traditional Occupational Therapy Intervention Targeting Compensatory Strategies (TOT) (n=19): 19. Visit 2 - Right Arm / Positive: Investigational Hand Therapy (IHT) Intervention Targeting the Nervous System (n=21): 0; Traditional Occupational Therapy Intervention Targeting Compensatory Strategies (TOT) (n=19): 0. Visit 3 - Right Arm / Negative: Investigational Hand Therapy (IHT) Intervention Targeting the Nervous System (n=21): 21; Traditional Occupational Therapy Intervention Targeting Compensatory Strategies (TOT) (n=19): 18. Visit 3 - Right Arm / Positive: Investigational Hand Therapy (IHT) Intervention Targeting the Nervous System (n=21): 0; Traditional Occupational Therapy Intervention Targeting Compensatory Strategies (TOT) (n=19): 1. Visit 4 - Right Arm / Negative: Investigational Hand Therapy (IHT) Intervention Targeting the Nervous System (n=21): 18; Traditional Occupational Therapy Intervention Targeting Compensatory Strategies (TOT) (n=19): 18. Visit 4 - Right Arm / Positive: Investigational Hand Therapy (IHT) Intervention Targeting the Nervous System (n=21): 0; Traditional Occupational Therapy Intervention Targeting Compensatory Strategies (TOT) (n=19): 0. Visit 5 - Right Arm / Negative: Investigational Hand Therapy (IHT) Intervention Targeting the Nervous System (n=21): 15; Traditional Occupational Therapy Intervention Targeting Compensatory Strategies (TOT) (n=19): 16. Visit 5 - Right Arm / Positive: Investigational Hand Therapy (IHT) Intervention Targeting the Nervous System (n=21): 0; Traditional Occupational Therapy Intervention Targeting Compensatory Strategies (TOT) (n=19): 1. Visit 1 - Left Arm / Negative: Investigational Hand Therapy (IHT) Intervention Targeting the Nervous System (n=21): 21; Traditional Occupational Therapy Intervention Targeting Compensatory Strategies (TOT) (n=19): 19. Visit 1 - Left Arm / Positive: Investigational Hand Therapy (IHT) Intervention Targeting the Nervous System (n=21): 0; Traditional Occupational Therapy Intervention Targeting Compensatory Strategies (TOT) (n=19): 0. Vis

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Number of Participants With Positive or Negative Ulnar Nerve Injury at the Right and Left Cubital Tunnel [Tinel's Test] [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]. Count Of Participants, Participants. Visit 1 - Right Cubital Tunnel / Negative: Investigational Hand Therapy (IHT) Intervention Targeting the Nervous System (n=21): 21; Traditional Occupational Therapy Intervention Targeting Compensatory Strategies (TOT) (n=19): 19. Visit 1 - Right Cubital Tunnel / Positive: Investigational Hand Therapy (IHT) Intervention Targeting the Nervous System (n=21): 0; Traditional Occupational Therapy Intervention Targeting Compensatory Strategies (TOT) (n=19): 0. Visit 2 - Right Cubital Tunnel / Negative: Investigational Hand Therapy (IHT) Intervention Targeting the Nervous System (n=21): 21; Traditional Occupational Therapy Intervention Targeting Compensatory Strategies (TOT) (n=19): 19. Visit 2 - Right Cubital Tunnel / Positive: Investigational Hand Therapy (IHT) Intervention Targeting the Nervous System (n=21): 0; Traditional Occupational Therapy Intervention Targeting Compensatory Strategies (TOT) (n=19): 0. Visit 3 - Right Cubital Tunnel / Negative: Investigational Hand Therapy (IHT) Intervention Targeting the Nervous System (n=21): 20; Traditional Occupational Therapy Intervention Targeting Compensatory Strategies (TOT) (n=19): 18. Visit 3 - Right Cubital Tunnel / Positive: Investigational Hand Therapy (IHT) Intervention Targeting the Nervous System (n=21): 1; Traditional Occupational Therapy Intervention Targeting Compensatory Strategies (TOT) (n=19): 1. Visit 4 - Right Cubital Tunnel / Negative: Investigational Hand Therapy (IHT) Intervention Targeting the Nervous System (n=21): 19; Traditional Occupational Therapy Intervention Targeting Compensatory Strategies (TOT) (n=19): 17. Visit 4 - Right Cubital Tunnel / Positive: Investigational Hand Therapy (IHT) Intervention Targeting the Nervous System (n=21): 0; Traditional Occupational Therapy Intervention Targeting Compensatory Strategies (TOT) (n=19): 1. Visit 5 - Right Cubital Tunnel / Negative: Investigational Hand Therapy (IHT) Intervention Targeting the Nervous System (n=21): 15; Traditional Occupational Therapy Intervention Targeting Compensatory Strategies (TOT) (n=19): 17. Visit 5 - Right Cubital Tunnel / Positive: Investigational Hand Therapy (IHT) Intervention Targeting the Nervous System (n=21): 0; Traditional Occupational Therapy Intervention Targeting Compensatory Strategies (TOT) (n=19): 0. Visit 1 - Left Cubital Tunnel / Negative: Investigational Hand Therapy (IHT) Intervention Targeting the Nervous System (n=21): 20; Traditional Occupational Therapy Intervention Targeting Compensatory Strategies (TOT) (n=19): 19. Visit 1 - Left Cubital Tunnel / Positive: Investigational Hand Therapy (IHT) Intervention Targetin

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Number of Participants With Positive or Negative Ulnar Nerve Injury at the Right and Left Volar Wrist [Tinel's Test] [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]. Count Of Participants, Participants. Visit 1 - Right Volar Wrist / Negative: Investigational Hand Therapy (IHT) Intervention Targeting the Nervous System (n=21): 21; Traditional Occupational Therapy Intervention Targeting Compensatory Strategies (TOT) (n=19): 19. Visit 1 - Right Volar Wrist / Positive: Investigational Hand Therapy (IHT) Intervention Targeting the Nervous System (n=21): 0; Traditional Occupational Therapy Intervention Targeting Compensatory Strategies (TOT) (n=19): 0. Visit 2 - Right Volar Wrist / Negative: Investigational Hand Therapy (IHT) Intervention Targeting the Nervous System (n=21): 21; Traditional Occupational Therapy Intervention Targeting Compensatory Strategies (TOT) (n=19): 19. Visit 2 - Right Volar Wrist / Positive: Investigational Hand Therapy (IHT) Intervention Targeting the Nervous System (n=21): 0; Traditional Occupational Therapy Intervention Targeting Compensatory Strategies (TOT) (n=19): 0. Visit 3 - Right Volar Wrist / Negative: Investigational Hand Therapy (IHT) Intervention Targeting the Nervous System (n=21): 21; Traditional Occupational Therapy Intervention Targeting Compensatory Strategies (TOT) (n=19): 19. Visit 3 - Right Volar Wrist / Positive: Investigational Hand Therapy (IHT) Intervention Targeting the Nervous System (n=21): 0; Traditional Occupational Therapy Intervention Targeting Compensatory Strategies (TOT) (n=19): 0. Visit 4 - Right Volar Wrist / Negative: Investigational Hand Therapy (IHT) Intervention Targeting the Nervous System (n=21): 19; Traditional Occupational Therapy Intervention Targeting Compensatory Strategies (TOT) (n=19): 18. Visit 4 - Right Volar Wrist / Positive: Investigational Hand Therapy (IHT) Intervention Targeting the Nervous System (n=21): 0; Traditional Occupational Therapy Intervention Targeting Compensatory Strategies (TOT) (n=19): 0. Visit 5 - Right Volar Wrist / Negative: Investigational Hand Therapy (IHT) Intervention Targeting the Nervous System (n=21): 15; Traditional Occupational Therapy Intervention Targeting Compensatory Strategies (TOT) (n=19): 17. Visit 5 - Right Volar Wrist / Positive: Investigational Hand Therapy (IHT) Intervention Targeting the Nervous System (n=21): 0; Traditional Occupational Therapy Intervention Targeting Compensatory Strategies (TOT) (n=19): 0. Visit 1 - Left Volar Wrist / Negative: Investigational Hand Therapy (IHT) Intervention Targeting the Nervous System (n=21): 20; Traditional Occupational Therapy Intervention Targeting Compensatory Strategies (TOT) (n=19): 19. Visit 1 - Left Volar Wrist / Positive: Investigational Hand Therapy (IHT) Intervention Targeting the Nervous System (n=21): 1; Traditi

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Mean Time-to-Event for Chemotherapy-Induced Peripheral Neuropathy (CIPN) Onset [Time of consent until the time of onset of CIPN of the hands or through 84 days of treatment]. Mean, Days (90% Confidence Interval). Investigational Hand Therapy (IHT)] Intervention Targeting the Nervous System (n=6): 76.0 (68.5 to 83.6); Traditional Occupational Therapy Intervention Targeting Compensatory Strategies (TOT) (n=4): 75.8 (68.5 to 83.2). Analysis, Investigational Hand Therapy (IHT)] Intervention Targeting the Nervous System vs Traditional Occupational Therapy Intervention Targeting Compensatory Strategies (TOT): p=0.614; Regression, Cox; other.