Clinical trial NCT06632626: Task-oriented Training on Hand Function in Taxanes-induced Peripheral Neuropathy
Official title: Task-oriented Training on Hand Function in Patients With Taxanes-induced Peripheral Neuropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Neuropathy
Chemotherapy Effect
Hand Function
Keywords: Breast cancer
hand dexterity
hand grip strength
task-oriented training
Taxanes-induced peripheral neuropathy
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-10-09
Enrollment: 60
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-blind, randomized, controlled trial
Primary purpose: TREATMENT

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.

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.

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

Primary outcomes:
measure: Hand grip strength
timeFrame: At baseline and after four weeks of intervention.
measure: Hand dexterity
timeFrame: At baseline and after four weeks of intervention.
measure: Hand function
timeFrame: At baseline and after four weeks of intervention.
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: faculty of physical therapy, Cairo university
Study officials:
affiliation: Cairo University
name: Shaimaa M A Elsayeh, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.