Chemotherapy Induced Peripheral NeuropathyNCT06737926
Effects of Sensorimotor Training With Chemotherapy-Induced Peripheral Neuropathy in Breast Cancer Patients
A study testing Sensorimotor Training Exercise and Conventional Exercise Therapy in people with Chemotherapy Induced Peripheral Neuropathy and Breast Cancer Patients, run by Riphah International University at 2 sites in Pakistan.
Trial summary
Chemotherapy-Induced Peripheral Neuropathy (CIPN) is a prevalent and clinically relevant side effect of chemotherapy in breast cancer patients. It occurs in 30-70% of cases. It can cause various sensory and motor symptoms. Specific exercise interventions have proven promising to target relevant symptoms. Read more about this study
- Who is it for?
- Ages 30 to 65 years, women only
- Conditions the study is for
- Chemotherapy Induced Peripheral Neuropathy, Breast Cancer Patients
- What is being tested?
- Sensorimotor Training Exercise and Conventional Exercise Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesPakistan
- Study dates
- 15 Jan 2024to Dec 2024
- 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 30 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Females with invasive ductal carcinoma, stages I-III
- Age ranged between 30-65 years
- 3-6 months post breast cancer diagnosis
- Those who have completed chemotherapy treatment and are medically stable
- CIPN symptoms as subjectively assessed by FACT/GOG-Ntx. Score ranges from 0-44 (5). 0 - 10: Minimal or no neurotoxicity symptoms, 11 - 20: Mild neurotoxicity symptoms, 21 - 30: Moderate neurotoxicity symptoms, 31 - 40: Severe neurotoxicity symptoms, 41 - 44: Very severe neurotoxicity symptoms
- For balance testing Fullerton Advanced Balance (FAB) scale was used. 0-19 = high risk of falls, 20-29 = moderate balance impairment, 30-40 = good balance. The cut off value is ≤ 25/40 Points.
- Objective neurological testing such as Achilles and patellar tendon reflexes (1 = agile, 2 = weak, 3 = missing), peripheral deep sensitivity (0=no sensitivity to 8=highest sensitivity), light touch perception (symmetrical or impaired), sense of position (1 = position recognized, 2 = only position of knee recognized, and 3 = no recognition) and lower leg strength (0 = no activity to 5 = normal force) rated on a Likert-scale
Who cannot join
- Women with additional types of cancer besides breast cancer
- Chronic medical conditions such as poorly controlled diabetes (6)
- Significant neurological (multiple sclerosis) or cardiopulmonary disease (myocardial infarction < 3 months) that may affect performance (6)
- Unstable bone metastasis
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan2 sites, 2 recruiting
- Recruiting
Mayo Hospital Lahore
Lahore, Punjab Province, 54000
Binash Afzal, MS-NMPT, 03434539092, binash.afzal@riphah.edu.pk
Binash Afzal, MS-NMPT
- Recruiting
Mayo Hospital
Lahore, Punjab Province, 54000
About this study
Official title: Effects of Sensorimotor Training on Pain Intensity, Perceived Balance Confidence and Functional Exercise Capacity With Chemotherapy-Induced Peripheral Neuropathy in Breast Cancer Patients
Chemotherapy-Induced Peripheral Neuropathy (CIPN) is a prevalent and clinically relevant side effect of chemotherapy in breast cancer patients. It occurs in 30-70% of cases. It can cause various sensory and motor symptoms. Specific exercise interventions have proven promising to target relevant symptoms. Therefore, the objective of this study is to determine the effects of Sensorimotor training on pain intensity, perceived balance confidence, and functional exercise capacity with chemotherapy-induced peripheral neuropathy in breast cancer patients.
Read the detailed description
The study incorporated a single blinded randomized controlled trial conducted at Mayo Hospital, Lahore. It involved 22 participants (N=22) recruited by using non-probability convenience sampling technique according to inclusion criteria and randomly allocated into either of two groups (Experimental group or Control group) using randomizer.org. The participants in experimental group performed sensorimotor training based on progressively challenging balance exercises on unstable surfaces. Participants performed three sets of exercises per session twice a week for 6 weeks, 45 minutes per session. The control group performed conventional exercises such as range of motion, stretching, strengthening, deep breathing and aerobic exercises for 2 times a week for 6 weeks, 45 minutes per session. Pre and post assessment of participants was done on numeric pain rating scale for pain intensity, TUG test for balance, activities-specific balance confidence scale for perceived balance confidence, 6-minute walk test for functional exercise capacity and EORTC QLQ C-30 for quality of life.
- Being tested
- Sensorimotor Training Exercise, Conventional Exercise Therapy
- Keywords
- Breast Cancer, Chemotherapy-Induced Peripheral Neuropathy, Postural Balance, Sensorimotor Neuropathy, Exercise
- Medical subject headings
- Breast Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensorimotor Training ExerciseBehavioural
Participants will perform sensorimotor training exercises designed to improve balance, reduce pain intensity, and enhance functional exercise capacity. The program will include progressive exercises focusing on proprioception, neuromuscular coordination, and functional mobility. Sessions will be conducted thrice weekly over 12 weeks, supervised by a physiotherapist.
Conventional Exercise TherapyBehavioural
Participants will undergo conventional exercise therapy, including stretching, strengthening, and aerobic exercises, based on standard physiotherapy protocols. The therapy aims to maintain joint mobility, reduce stiffness, and improve general physical fitness. Sessions will be conducted thrice weekly over 12 weeks, supervised by a physiotherapist.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Experimental Group receiving Sensorimotor Training Exercise. | Experimental | Participants will undergo sensorimotor training exercises targeting balance, pain reduction, and functional exercise capacity. Receives: Behavioral: Sensorimotor Training Exercise |
| Group B: Control Group receiving Conventional Exercise Therapy. | Active comparator | Participants will receive conventional exercise therapy as per standard guidelines. Receives: Behavioral: Conventional Exercise Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Rating Scale (NPRS)
It is a uni-dimensional subjective measure of pain intensity in adults, including those with cancer pain. Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible.
Measured: 6 weeks
TUG Test
It is used to determine the fall risk and measure the progress of balance. Mobility and balance is assessed based on time to complete the test: < 10 seconds = normal. < 20 seconds = good mobility < 30 seconds = walking and balance problems
Measured: 6 weeks
Activities-Specific Balance Confidence Scale
The ABC-Scale is a self-reported assessment of the participant's level of confidence in static and dynamic balance while doing functional activities
Measured: 6 weeks
6-Minute Walk Test
The 6-minute walk test (6MWT) is a standardized field test used to predict cardio-respiratory fitness in healthy individuals, as well as to assess functional exercise capacity and responsiveness to rehabilitation treatments in a variety of patient groups
Measured: 6 weeks
Secondary outcomes (3)
Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) Subscale
The FACT/GOG Ntx subscale is designed to measure chemotherapy-induced PN. It contains 11 items covering sensory neuropathy, motor neuropathy, hearing neuropathy, and dysfunction associated with neuropathy
Measured: 6 weeks
EORTC Core Quality of Life Questionnaire (EORTC QLQ-C30)
The EORTC QLQ-C30 is composed of nine multi-item scales: 5 functioning scales (physical, role, cognitive, emotional and social), a global QOL scale, and 3 symptom scales (fatigue, pain and nausea/vomiting).
Measured: 6 weeks
Fullerton Advanced Balance Scale (FAB Scale)
It is a screening tool which can be used in different group. It has long form (consisting of 10 tasks) and a short form (consisting of 4 tasks). The scale consists of a 5-point Likert scale from 0-4.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2024
- Study start15 Jan 2024
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy Induced Peripheral NeuropathyStudies of the same condition, open and under way.
- More trials run by Riphah International 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammad Asrar Yousaf, M.phil, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06737926
- Sponsor's protocol ID
- REC/RCR&AHS/24/0204
- Status last verified
- Dec 2024
- First submitted
- 12 Dec 2024
- Last updated
- 17 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Sensorimotor Training on Pain Intensity, Perceived Balance Confidence and Functional Exercise Capacity With Chemotherapy-Induced Peripheral Neuropathy in Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT06737926
- Acronym / sponsor ID
- REC/RCR&AHS/24/0204
- Keywords
- Breast Cancer, Chemotherapy-Induced Peripheral Neuropathy, Postural Balance, Sensorimotor Neuropathy, Exercise
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 17 Dec 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-Induced Peripheral Neuropathy (CIPN) is a prevalent and clinically relevant side effect of chemotherapy in breast cancer patients. It occurs in 30-70% of cases. It can cause various sensory and motor symptoms. Specific exercise interventions have proven promising to target relevant symptoms. Therefore, the objective of this study is to determine the effects of Sensorimotor training on pain intensity, perceived balance confidence, and functional exercise capacity with chemotherapy-induced peripheral neuropathy in breast cancer patients.
Detailed description
The study incorporated a single blinded randomized controlled trial conducted at Mayo Hospital, Lahore. It involved 22 participants (N=22) recruited by using non-probability convenience sampling technique according to inclusion criteria and randomly allocated into either of two groups (Experimental group or Control group) using randomizer.org. The participants in experimental group performed sensorimotor training based on progressively challenging balance exercises on unstable surfaces. Participants performed three sets of exercises per session twice a week for 6 weeks, 45 minutes per session. The control group performed conventional exercises such as range of motion, stretching, strengthening, deep breathing and aerobic exercises for 2 times a week for 6 weeks, 45 minutes per session. Pre and post assessment of participants was done on numeric pain rating scale for pain intensity, TUG test for balance, activities-specific balance confidence scale for perceived balance confidence, 6-minute walk test for functional exercise capacity and EORTC QLQ C-30 for quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Experimental Group receiving Sensorimotor Training Exercise. | Experimental | Behavioral: Sensorimotor Training ExerciseParticipants will undergo sensorimotor training exercises targeting balance, pain reduction, and functional exercise capacity. |
| Group B: Control Group receiving Conventional Exercise Therapy. | Active comparator | Behavioral: Conventional Exercise TherapyParticipants will receive conventional exercise therapy as per standard guidelines. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Females with invasive ductal carcinoma, stages I-III
- Age ranged between 30-65 years
- 3-6 months post breast cancer diagnosis
- Those who have completed chemotherapy treatment and are medically stable
- CIPN symptoms as subjectively assessed by FACT/GOG-Ntx. Score ranges from 0-44 (5). 0 - 10: Minimal or no neurotoxicity symptoms, 11 - 20: Mild neurotoxicity symptoms, 21 - 30: Moderate neurotoxicity symptoms, 31 - 40: Severe neurotoxicity symptoms, 41 - 44: Very severe neurotoxicity symptoms
Key exclusion criteria (4 listed)
- Women with additional types of cancer besides breast cancer
- Chronic medical conditions such as poorly controlled diabetes (6)
- Significant neurological (multiple sclerosis) or cardiopulmonary disease (myocardial infarction < 3 months) that may affect performance (6)
- Unstable bone metastasis
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 |
|---|---|---|
| Sensorimotor Training ExerciseParticipants will perform sensorimotor training exercises designed to improve balance, reduce pain intensity, and enhance functional exercise capacity. The program will include progressive exercises focusing on proprioception, neuromuscular coordination, and functional mobility. Sessions will be conducted thrice weekly over 12 weeks, supervised by a physiotherapist. | Behavioural | Group A: Experimental Group receiving Sensorimotor Training Exercise. |
| Conventional Exercise TherapyParticipants will undergo conventional exercise therapy, including stretching, strengthening, and aerobic exercises, based on standard physiotherapy protocols. The therapy aims to maintain joint mobility, reduce stiffness, and improve general physical fitness. Sessions will be conducted thrice weekly over 12 weeks, supervised by a physiotherapist. | Behavioural | Group B: Control Group receiving Conventional Exercise Therapy. |
Primary outcome
Numeric Pain Rating Scale (NPRS)
Time frame: 6 weeks
It is a uni-dimensional subjective measure of pain intensity in adults, including those with cancer pain. Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible.
TUG Test
Time frame: 6 weeks
It is used to determine the fall risk and measure the progress of balance. Mobility and balance is assessed based on time to complete the test: < 10 seconds = normal. < 20 seconds = good mobility < 30 seconds = walking and balance problems
Activities-Specific Balance Confidence Scale
Time frame: 6 weeks
The ABC-Scale is a self-reported assessment of the participant's level of confidence in static and dynamic balance while doing functional activities
6-Minute Walk Test
Time frame: 6 weeks
The 6-minute walk test (6MWT) is a standardized field test used to predict cardio-respiratory fitness in healthy individuals, as well as to assess functional exercise capacity and responsiveness to rehabilitation treatments in a variety of patient groups
3 secondary outcomes
Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) Subscale
Time frame: 6 weeks
EORTC Core Quality of Life Questionnaire (EORTC QLQ-C30)
Time frame: 6 weeks
Fullerton Advanced Balance Scale (FAB Scale)
Time frame: 6 weeks
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 17 Dec 2024.
- Twice-weekly neuromuscular stimulation training reduced the incidence of chemotherapy-induced peripheral neuropathy compared with standard care, especially among patients taking vinca alkaloids.Link provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Chemotherapy Induced Peripheral Neuropathy
Active, not recruiting
The AIUR Trial: Surgical Gloves to Prevent Peripheral Neuropathy
Chemotherapy-induced Peripheral Neuropathy
Not yet recruiting
Continuous Controlled Cooling for Prevention of Chemotherapy-Induced Peripheral Neuropathy
Chemotherapy Induced Peripheral Neuropathy (CIPN)
RecruitingObservational study
Relationship Between Great Toe Strength And Symptoms of Chemotherapy-Induced Peripheral Neuropathy (CIPN)
Chemotherapy-induced Peripheral Neuropathy (CIPN), Healthy
Not yet recruiting
The Effect of Aerobic and Resistance Training With and Without Neurodynamic Exercises on Chemotherapy-induced Peripheral Neuropathy Symptoms and Associated Neuro-immune Mechanisms
Chemotherapy Induced Peripheral Neuropathy (CIPN)
RecruitingEarly Phase 1
Neuroprotective Potential of Cannabidiol (CBD) in Preventing Oxaliplatin (Ox)-Induced Neuropathy
Oxaliplatin Induced Peripheral Neuropathy in Cancer Patients, Metastatic Colorectal Cancer (CRC)
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.
Muhammad Asrar Yousaf, M.phil principal investigator
Riphah International University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sensorimotor Training Exercise and Conventional Exercise Therapy in people with Chemotherapy Induced Peripheral Neuropathy and Breast Cancer Patients, run by Riphah International University at 2 sites in Pakistan.
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 7 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 17 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Pakistan. 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?
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 Imran Amjad, PHD (03324390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Pain Rating Scale (NPRS) (time frame: 6 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Dec 2024.