Peripheral NeuropathyNCT07321236
Effect of Hands and Feet Exercises on Taxane Based Chemotherapy Induced Peripheral Neuropathy in Patients With Solid Tumors
A study testing Structured Hand and Foot Exercises in people with Peripheral Neuropathy, run by University of Health Sciences Lahore.
Trial summary
The goal of this clinical trial is to determine whether hand and foot exercises can reduce the severity of Taxane-based chemotherapy-induced peripheral neuropathy (CIPN) in adult cancer patients aged 20-60 years who have Grade 1I neuropathy as defined by the NCI-CTCAE criteria. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Peripheral Neuropathy
- What is being tested?
- Structured Hand and Foot Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to 1 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Cancer patients receiving taxane-based chemotherapy on alternate week.
- Age 20-60 years, both male and female.
- Patients having Grade I neuropathy by NCI-CTCEA criteria.
Who cannot join
- Patients with peripheral neuropathy not caused by chemotherapy.
- Patient with type-1 and type- 2 diabetes.
- Patients with neuropsychiatric disorders.
- Patients having any skin ulcer.
- Individuals having hand foot fracture and varicose veins.
- Individuals with paraplegia.
- Patients receiving radiotherapy.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Hands and Feet Exercises on Severity of Taxane-Based Chemotherapy-Induced Peripheral Neuropathy in Patients With Solid Tumors: A Randomized Controlled Trial
The goal of this clinical trial is to determine whether hand and foot exercises can reduce the severity of Taxane-based chemotherapy-induced peripheral neuropathy (CIPN) in adult cancer patients aged 20-60 years who have Grade 1I neuropathy as defined by the NCI-CTCAE criteria.
The main questions it aims to answer are:
Read more
- Do hand and foot exercises reduce the severity of sensory and motor neuropathic symptoms in patients receiving Taxane based chemotherapy?
- Is the severity of peripheral neuropathy lower in the exercise group compared to patients receiving standard care alone? Researchers will compare patients receiving standard care (control group) with those receiving standard care plus a structured hand and foot exercise program (experimental group) to see if the exercises lead to greater improvement in neuropathy severity scores.
Participants will:
- Receive baseline assessment using the EORTC QLQ-CIPN20 questionnaire.
- In the experimental group, learn and perform a 15-minute hand and foot exercise routine on chemotherapy day and continue it at home using a provided brochure.
- Participate in telephonic follow-ups to support compliance and monitor symptoms.
- Undergo a follow-up assessment at alternate week to measure changes in neuropathy severity.
Read the detailed description
The study focuses on adults between 20 and 60 years old who are receiving Taxane chemotherapy and have early-stage (Grade II) neuropathy. At this stage, patients usually notice changes in sensation, but these changes are still manageable. By starting exercises early, the study aims to see whether regular movement of the hands and feet can help reduce the intensity of these symptoms over time.
Participants will be randomly assigned to one of two groups. One group will continue with their routine medical care for neuropathy, which may include medication and guidance from their healthcare team. The other group will receive the same standard care but will also be taught a short set of hand and foot exercises. These exercises take around 15 minutes to complete and are performed once a day. Patients in the exercise group will first learn the routine on the day of their chemotherapy session and will receive a brochure so they can continue the exercises at home. Telephone check-ins will be used to support patients, answer questions, and encourage regular practice.
To understand how symptoms change, all participants will complete a questionnaire called the EORTC QLQ-CIPN20 at the beginning of the study and again after several weeks. This tool helps measure nerve-related symptoms and how much they affect daily life. The results will allow the research team to compare how symptoms change in both groups over the course of the study.
By examining whether a simple, low-cost exercise routine can make a meaningful difference, this study hopes to offer cancer patients a practical way to manage neuropathy alongside their chemotherapy. If effective, these exercises could become a helpful addition to supportive care in oncology settings, improving comfort and quality of life during treatment.
- Conditions
- Peripheral Neuropathy
- Being tested
- Structured Hand and Foot Exercises
- Keywords
- Peripheral neuropathy, Taxane, Chemotherapy
- Medical subject headings
- Peripheral Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured Hand and Foot ExercisesOther
The intervention consists of a structured hand and foot exercise program specifically designed for patients experiencing chemotherapy-induced peripheral neuropathy during Taxane-based treatment. It is distinct from general physiotherapy or mobility exercises because it targets peripheral nerve function, joint mobility, and circulation in the hands and feet, aiming to reduce the severity of neuropathic symptoms.
| Study group | Role | What they receive |
|---|---|---|
| Standard Care (Control) | No intervention | Standard care |
| Hand and Foot Exercise Program + Standard Care (Experimental) | Experimental | Structured Hand and Foot Exercises and standard care Receives: Other: Structured Hand and Foot Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of peripheral neuropathy
The primary outcome of this study is the severity of chemotherapy-induced peripheral neuropathy in cancer patients receiving Taxane-based chemotherapy. Severity will be measured using the EORTC QLQ-CIPN20 questionnaire, which assesses sensory symptoms (tingling, numbness, burning), motor symptoms (difficulty gripping or walking), and autonomic symptoms (such as dizziness). Each item is scored from 1 (not at all) to 4 (very much), with higher scores indicating more severe neuropathy. Assessments will be conducted at baseline (week 1) and week 8 to determine whether the hand and foot exercise program reduces symptom severity compared to standard care alone.
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2026
- Study start1 Jun 2026 (estimated)
- Primary completion2 Aug 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 University of Health Sciences LahoreThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned in a 1:1 ratio to one of two parallel arms and will remain in that assigned arm for the duration of the study.
- Masking
- None (open label)
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Health Sciences Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nusrat Hussain, University of Health Sciences Lahore
- Investigators
- Kausar Bano, MBBS, FCPS, Study chair, Jinnah Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07321236
- Sponsor's protocol ID
- NHussain
- Status last verified
- Apr 2026
- First submitted
- 21 Dec 2025
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yeo F, Ng CC, Loh KWJ, Molassiotis A, Cheng HL, Au JSK, Leung KT, Li YC, Wong KH, Suen L, Chan CW, Yorke J, Farrell C, Bandla A, Ang E, Lopez V, Sundar R, Chan A. Minimal clinically important difference of the EORTC QLQ-CIPN20 for worsening peripheral neuropathy in patients receiving neurotoxic chemotherapy. Support Care Cancer. 2019 Dec;27(12):4753-4762. doi: 10.1007/s00520-019-04771-8. Epub 2019 Apr 10.
PubMed 30972646
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Hands and Feet Exercises on Severity of Taxane-Based Chemotherapy-Induced Peripheral Neuropathy in Patients With Solid Tumors: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07321236
- Acronym / sponsor ID
- NHussain
- Conditions
- Peripheral Neuropathy
- Keywords
- Peripheral neuropathy, Taxane, Chemotherapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- University of Health Sciences LahoreUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 2 Aug 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 6 Jan 2026 (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.
The goal of this clinical trial is to determine whether hand and foot exercises can reduce the severity of Taxane-based chemotherapy-induced peripheral neuropathy (CIPN) in adult cancer patients aged 20-60 years who have Grade 1I neuropathy as defined by the NCI-CTCAE criteria.
The main questions it aims to answer are:
- Do hand and foot exercises reduce the severity of sensory and motor neuropathic symptoms in patients receiving Taxane based chemotherapy?
- Is the severity of peripheral neuropathy lower in the exercise group compared to patients receiving standard care alone? Researchers will compare patients receiving standard care (control group) with those receiving standard care plus a structured hand and foot exercise program (experimental group) to see if the exercises lead to greater improvement in neuropathy severity scores.
Participants will:
- Receive baseline assessment using the EORTC QLQ-CIPN20 questionnaire.
- In the experimental group, learn and perform a 15-minute hand and foot exercise routine on chemotherapy day and continue it at home using a provided brochure.
- Participate in telephonic follow-ups to support compliance and monitor symptoms.
- Undergo a follow-up assessment at alternate week to measure changes in neuropathy severity.
Detailed description
The study focuses on adults between 20 and 60 years old who are receiving Taxane chemotherapy and have early-stage (Grade II) neuropathy. At this stage, patients usually notice changes in sensation, but these changes are still manageable. By starting exercises early, the study aims to see whether regular movement of the hands and feet can help reduce the intensity of these symptoms over time.
Participants will be randomly assigned to one of two groups. One group will continue with their routine medical care for neuropathy, which may include medication and guidance from their healthcare team. The other group will receive the same standard care but will also be taught a short set of hand and foot exercises. These exercises take around 15 minutes to complete and are performed once a day. Patients in the exercise group will first learn the routine on the day of their chemotherapy session and will receive a brochure so they can continue the exercises at home. Telephone check-ins will be used to support patients, answer questions, and encourage regular practice.
To understand how symptoms change, all participants will complete a questionnaire called the EORTC QLQ-CIPN20 at the beginning of the study and again after several weeks. This tool helps measure nerve-related symptoms and how much they affect daily life. The results will allow the research team to compare how symptoms change in both groups over the course of the study.
By examining whether a simple, low-cost exercise routine can make a meaningful difference, this study hopes to offer cancer patients a practical way to manage neuropathy alongside their chemotherapy. If effective, these exercises could become a helpful addition to supportive care in oncology settings, improving comfort and quality of life during treatment.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned in a 1:1 ratio to one of two parallel arms and will remain in that assigned arm for the duration of the study.
| Arm | Type | Receives |
|---|---|---|
| Standard Care (Control) | No intervention | –Standard care |
| Hand and Foot Exercise Program + Standard Care (Experimental) | Experimental | Other: Structured Hand and Foot ExercisesStructured Hand and Foot Exercises and standard care |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Cancer patients receiving taxane-based chemotherapy on alternate week.
- Age 20-60 years, both male and female.
- Patients having Grade I neuropathy by NCI-CTCEA criteria.
Key exclusion criteria (7 listed)
- Patients with peripheral neuropathy not caused by chemotherapy.
- Patients with neuropsychiatric disorders.
- Patients having any skin ulcer.
- Individuals having hand foot fracture and varicose veins.
- Individuals with paraplegia.
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 |
|---|---|---|
| Structured Hand and Foot ExercisesThe intervention consists of a structured hand and foot exercise program specifically designed for patients experiencing chemotherapy-induced peripheral neuropathy during Taxane-based treatment. It is distinct from general physiotherapy or mobility exercises because it targets peripheral nerve function, joint mobility, and circulation in the hands and feet, aiming to reduce the severity of neuropathic symptoms. | Other | Hand and Foot Exercise Program + Standard Care (Experimental) |
Primary outcome
Severity of peripheral neuropathy
Time frame: 6 Months
The primary outcome of this study is the severity of chemotherapy-induced peripheral neuropathy in cancer patients receiving Taxane-based chemotherapy. Severity will be measured using the EORTC QLQ-CIPN20 questionnaire, which assesses sensory symptoms (tingling, numbness, burning), motor symptoms (difficulty gripping or walking), and autonomic symptoms (such as dizziness). Each item is scored from 1 (not at all) to 4 (very much), with higher scores indicating more severe neuropathy. Assessments will be conducted at baseline (week 1) and week 8 to determine whether the hand and foot exercise program reduces symptom severity compared to standard care alone.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Background: PubMed 30972646Yeo F, Ng CC, Loh KWJ, Molassiotis A, Cheng HL, Au JSK, Leung KT, Li YC, Wong KH, Suen L, Chan CW, Yorke J, Farrell C, Bandla A, Ang E, Lopez V, Sundar R, Chan A. Minimal clinically important difference of the EORTC QLQ-CIPN20 for worsening peripheral neuropathy in patients receiving neurotoxic chemotherapy. Support Care Cancer. 2019 Dec;27(12):4753-4762. doi: 10.1007/s00520-019-04771-8. Epub 2019 Apr 10.
- Article: "The effect of hand and foot exercises on peripheral neuropathy and quality of life in women with breast cancer: a randomized controlled trial" (2025).Link provided by the sponsor.
- Article:A Case Study on the Integrated Rehabilitation of Chemotherapy-Induced Peripheral Neuropathy in a Patient with Stage IV Breast CancerLink provided by the sponsor.
- Article: Striding beyond numbness: a non-randomized controlled study of an exercise program for breast cancer patients with chemotherapy-induced peripheral neuropathyLink provided by the sponsor.
- 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.
Kausar Bano, MBBS, FCPS study chair
Jinnah Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Structured Hand and Foot Exercises in people with Peripheral Neuropathy, run by University of Health Sciences Lahore.
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 3 inclusion and 7 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: opening soon, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact N Hussain, Generic BSN (+923085182487 ext. +92, hussainnusrat640@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of peripheral neuropathy (time frame: 6 Months). 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 NCT07321236, which also lists 1 linked publication.
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 6 May 2026.