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

NCT ID: NCT06632626

Last Updated: 2024-10-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2024-06-01

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).

Detailed Description

Task-oriented training, a type of exercise where exercises are organized into tasks, concentrates on enhancing particular functional abilities through useful, goal-directed activities. So, the purpose of the study to explore the effectiveness of task-oriented training (TOT) on grip strength, hand dexterity and upper extremity function in patients with taxanes-induced peripheral neuropathy.

Conditions

Peripheral Neuropathy; Chemotherapy Effect; Hand Function

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Task oriented training group

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.

Group Type: EXPERIMENTAL

Task oriented training exercises

Intervention Type: OTHER

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

Traditional physical therapy

Intervention Type: OTHER

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

Traditional physical therapy group

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.

Group Type: ACTIVE_COMPARATOR

Traditional physical therapy

Intervention Type: OTHER

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

Interventions

Task oriented training exercises

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

Intervention Type: OTHER

Traditional physical therapy

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Arwa Reda Hashem

Physical Therapy Specialist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shaimaa M A Elsayeh, PhD

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

faculty of physical therapy, Cairo university

Giza, , Egypt

Countries

Egypt

References

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.

Reference Type: BACKGROUND

PMID: 31342880 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31976819 (View on PubMed)

Other Identifiers

P.T.REC/012/00460

Identifier Type: -

Identifier Source: org_study_id