Peripheral NeuropathyNCT06632626
Task-oriented Training on Hand Function in Taxanes-induced Peripheral Neuropathy
A study testing Task oriented training exercises and Traditional physical therapy in people with Peripheral Neuropathy and Chemotherapy Effect, run by Cairo University at 1 site in Egypt.
Trial 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). Read more about this study
- Who is it for?
- Ages 35 to 65 years, women only
- Conditions the study is for
- Peripheral Neuropathy, Chemotherapy Effect, Hand Function
- What is being tested?
- Task oriented training exercises and Traditional physical therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2023to 1 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Task-oriented Training on Hand Function in Patients With Taxanes-induced Peripheral Neuropathy
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).
Read the 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
- Being tested
- Task oriented training exercises, Traditional physical therapy
- Keywords
- Breast cancer, hand dexterity, hand grip strength, task-oriented training, Taxanes-induced peripheral neuropathy
- Medical subject headings
- Peripheral Nervous System Diseases, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Task oriented training exercisesOther
Task oriented training is a type of exercises in form of tasks using papers, pens, scissors, clips, coins, screws and clay
Traditional physical therapyOther
Traditional physical therapy inform of mobilization, strengthening exercises of hand and streching exercises.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Traditional physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hand grip strength
Hand grip strength (HGS) was measured in the dominant hand for each patient using The CAMRY dynamometer
Measured: At baseline and after four weeks of intervention.
Hand dexterity
The nine-hole peg test was used to assess the hand dexterity
Measured: 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)
Measured: At baseline and after four weeks of intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2024
- Study start1 Sep 2023
- Primary completion1 Apr 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Peripheral NeuropathyStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-blind, randomized, controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arwa Reda Hashem, Cairo University
- Investigators
- Shaimaa M A Elsayeh, PhD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06632626
- Sponsor's protocol ID
- P.T.REC/012/00460
- Status last verified
- Oct 2024
- First submitted
- 7 Oct 2024
- Last updated
- 18 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31342880Andersen 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.
PubMed 31976819
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Task-oriented Training on Hand Function in Patients With Taxanes-induced Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT06632626
- Acronym / sponsor ID
- P.T.REC/012/00460
- Conditions
- Peripheral Neuropathy, Chemotherapy Effect, Hand Function
- Keywords
- Breast cancer, hand dexterity, hand grip strength, task-oriented training, Taxanes-induced peripheral neuropathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 9 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Single-blind, randomized, controlled trial
| Arm | Type | Receives |
|---|---|---|
| Task oriented training group | Experimental | Other: Task oriented training exercises, Other: Traditional physical therapyThis 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. |
| Traditional physical therapy group | Active comparator | Other: Traditional physical therapyThis 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. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Task oriented training exercisesTask oriented training is a type of exercises in form of tasks using papers, pens, scissors, clips, coins, screws and clay | Other | Task oriented training group |
| Traditional physical therapyTraditional physical therapy inform of mobilization, strengthening exercises of hand and streching exercises. | Other | Task oriented training group, Traditional physical therapy group |
Primary outcome
Hand grip strength
Time frame: At baseline and after four weeks of intervention.
Hand grip strength (HGS) was measured in the dominant hand for each patient using The CAMRY dynamometer
Hand dexterity
Time frame: At baseline and after four weeks of intervention.
The nine-hole peg test was used to assess the hand dexterity
Hand function
Time frame: At baseline and after four weeks of intervention.
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2024.
- Background: PubMed 31342880Andersen 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.
- Background: PubMed 31976819Andersen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shaimaa M A Elsayeh, PhD principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Task oriented training exercises and Traditional physical therapy in people with Peripheral Neuropathy and Chemotherapy Effect, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hand grip strength (time frame: At baseline and after four weeks of intervention.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06632626, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2024.