Task-oriented Training on Hand Function in Taxanes-induced Peripheral Neuropathy

NCT06632626 | Completed

• 1 other identifier: P.T.REC/012/00460
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Chemotherapy based on taxanes is commonly used to treat breast cancer. However, chemotherapy-induced peripheral neuropathy (CIPN), a side effect of taxanes, impairs a patient's grip strength, hand dexterity, and upper extremity function which affects quality of life (QOL).

Conditions

Peripheral Neuropathy; Chemotherapy Effect; Hand Function

Keywords

Breast cancer; hand dexterity; hand grip strength; task-oriented training; Taxanes-induced peripheral neuropathy

Outcome Measures

Primary Outcomes (3)

• Hand grip strength

  Hand grip strength (HGS) was measured in the dominant hand for each patient using The CAMRY dynamometer

  At baseline and after four weeks of intervention.

• Hand dexterity

  The nine-hole peg test was used to assess the hand dexterity

  At baseline and after four weeks of intervention.

• Hand function

  Each patient was asked to answer the questions of the six scales in the Arabic version of Michigan hand questionnaire (1- Overall hand function, 2-Activities of Daily Living, 3- Work performance, 4- Pain, 5- Aesthetics, and 6- Satisfaction with hand function)

  At baseline and after four weeks of intervention.

Study Arms (2)

Task oriented training group

EXPERIMENTAL

This group included 30 patients suffering from taxanes induced peripheral neuropathy who received 30 minutes of task-oriented exercises, three sessions per week for four weeks along with 30 minutes of the traditional physical therapy.

Other: Task oriented training exercises; Other: Traditional physical therapy

Traditional physical therapy group

ACTIVE COMPARATOR

This group included 30 patients suffering from taxanes induced peripheral neuropathy who received 30 minutes of the traditional physical therapy only, three sessions per week for four weeks.

Other: Traditional physical therapy

Interventions

Task oriented training exercises OTHER

Task oriented training is a type of exercises in form of tasks using papers, pens, scissors, clips, coins, screws and clay

Task oriented training group

Traditional physical therapy OTHER

Traditional physical therapy inform of mobilization, strengthening exercises of hand and streching exercises.

Task oriented training group; Traditional physical therapy group

Eligibility Criteria

• Age: 35 Years - 65 Years
• Gender Eligibility Details: Biologically female patients only
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients were females only.
• Their ages range from 35 to 65.
• All patients suffered from CIPN after using taxanes (anti-cancer agent causing neurotoxic effect).
• Diagnosis of CIPN was determined based on symptom history or the presence of stocking glove pattern "distal dysesthesias, pain and numbness" beginning after taxanes intake.
• All patients enrolled to the study had their informed consent.
• Patients suffer from affected brachial plexus.

You may not qualify if:

• Patients had pain or numbness in the upper extremity due to other reasons like trauma (fracture), CNS diseases (cerebral infarction), other diseases with neurological symptoms like (diabetes, rheumatoid arthritis or cervical myelopathy).
• Patients had bone, brain or spinal cord metastases.
• Patients who had history of psychiatric disorders like: depression and schizophrenia or cognitive decline that may hinder them from active participation in the study.
• Patients exhibited only acute neuropathy like in patients using oxaliplatin.
• Patients had pain or numbness in the upper extremity due to other reasons like trauma (fracture), CNS diseases (cerebral infarction), other diseases with neurological symptoms like (diabetes, rheumatoid arthritis or cervical myelopathy).
• Patients had bone, brain or spinal cord metastases.
• Patients who had history of psychiatric disorders like: depression and schizophrenia or cognitive decline that may hinder them from active participation in the study.
• Patients exhibited only acute neuropathy like in patients using oxaliplatin

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

faculty of physical therapy, Cairo university

Giza, 11432, Egypt

Location

Related Publications (2)

• Andersen Hammond E, Pitz M, Shay B. Neuropathic Pain in Taxane-Induced Peripheral Neuropathy: Evidence for Exercise in Treatment. Neurorehabil Neural Repair. 2019 Oct;33(10):792-799. doi: 10.1177/1545968319860486. Epub 2019 Jul 25.

  PMID: 31342880 BACKGROUND

• Andersen Hammond E, Pitz M, Steinfeld K, Lambert P, Shay B. An Exploratory Randomized Trial of Physical Therapy for the Treatment of Chemotherapy-Induced Peripheral Neuropathy. Neurorehabil Neural Repair. 2020 Mar;34(3):235-246. doi: 10.1177/1545968319899918. Epub 2020 Jan 24.

  PMID: 31976819 BACKGROUND

MeSH Terms

Conditions

Peripheral Nervous System Diseases; Breast Neoplasms

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Shaimaa M A Elsayeh, PhD

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical Therapy Specialist

Model Details: Single-blind, randomized, controlled trial

Study Record Dates

• First Submitted: October 7, 2024
• First Posted: October 9, 2024
• Study Start: September 1, 2023
• Primary Completion: April 1, 2024
• Study Completion: June 1, 2024
• Last Updated: October 18, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)