PolyneuropathyFOTNEVNCT06904989
A New Cancer Rehabilitation Process for Chemotherapy-Induced Foot Neuropathy Using Orthopedic Devices
A study testing Silicone orthosis and Standard Treatment in people with Polyneuropathy and Breast Cancer, run by Vastra Gotaland Region at 1 site in Sweden.
Trial summary
The goal of this clinical study is to evaluate a new process for assessing and alleviating chemotherapy-induced peripheral neuropathy in the feet in patients treated with chemotherapy for early stage breast cancer. It will also compare two orthopedic interventions for symptom relief. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Polyneuropathy, Breast Cancer
- What is being tested?
- Silicone orthosis and Standard Treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSweden
- Study dates
- 1 Dec 2024to Oct 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with breast cancer receiving treatment at the Oncology Department, Sahlgrenska University Hospital (SU).
- Have undergone treatment with taxanes.
- Aged 18 years or older.
- Able to understand spoken and written Swedish.
- Patients who can ambulate with or without assistive walking devices.
- CTCAE grading above 2 at a medical visit after completing treatment.
Who cannot join
- Bilateral amputation at the thigh level.
- Previously diagnosed neurological disease or neurological impairment affecting the feet.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Sahlgrenska University Hospital
Gothenburg, 413 45
Malin Rydholm, MD, 0046705568678, malin.rydholm@vgregion.se
Ulla Hellstrand Tang, Orthopedic engineer
About this study
Official title: Implementation and Evaluation of a New Cancer Rehabilitation Process for the Assessment and Treatment of Chemotherapy-Induced Foot Neuropathy - A Collaborative Project Between Oncology Clinic and Orthopedic Technology Department 2.0.
The goal of this clinical study is to evaluate a new process for assessing and alleviating chemotherapy-induced peripheral neuropathy in the feet in patients treated with chemotherapy for early stage breast cancer. It will also compare two orthopedic interventions for symptom relief. The main questions it aims to answer are:
Can an orthopedic silicone orthosis reduce chemotherapy-induced peripheral neuropathy symptoms in the feet? How does the effectiveness of the silicone orthosis compare to standard orthopedic treatment with insoles and shoes?
Read more
Participants will:
Use either a silicone orthosis or standard orthopedic treatment Have contact with the clinic for assessments and follow-ups Report their symptoms and functional improvements over time
Read the detailed description
Background and Rationale
This study aims to develop and evaluate a structured multidisciplinary rehabilitation process for assessing and managing chemotherapy-induced peripheral neuropathy in the feet. The project establishes a new collaboration between the Oncology Department and the Department of Orthopedic Technology at Sahlgrenska University Hospital, integrating an orthopedic approach into cancer rehabilitation.
Chemotherapy-induced peripheral neuropathy is a common side effect of chemotherapy, affecting 50-90% of patients undergoing cancer treatment. Symptoms such as numbness, tingling, pain, and sensory loss in the feet can lead to chronic discomfort, impaired balance, and reduced quality of life. Despite its prevalence, there are no standardized guidelines for grading or managing chemotherapy-induced peripheral neuropathy within rehabilitation. Additionally, structured follow-up for chemotherapy-induced peripheral neuropathy after chemotherapy is lacking in Sweden, and there are limited effective treatment options available.
This research project aims to develop a structured process for assessing and managing chemotherapy-induced peripheral neuropathy in the feet and to evaluate two orthopedic interventions:
- Current standard treatment - customized insoles and orthopedic shoes.
- A novel intervention - a silicone orthosis, designed as a soft, sock-like device for indoor use.
Although silicone orthoses have been introduced in limited clinical settings in Sweden, their effectiveness for chemotherapy-induced peripheral neuropathy remains untested. This study seeks to evaluate whether this new intervention can alleviate symptoms and improve mobility and quality of life for breast cancer patients experiencing chemotherapy-induced peripheral neuropathy .
Study Objectives
The overall aim is to establish and evaluate a new process for assessing and alleviating symptoms in the feet through orthopedic technology. Specifically, the study will:
- Compare the effectiveness of two orthopedic interventions (custom insoles vs. silicone orthosis).
- Investigate patient-reported outcomes regarding symptom relief, quality of life, and functional mobility.
Study Design and Methodology The study consists of a pilot phase with, followed by a potential randomized controlled trial if preliminary results are promising. This pilot study will include 40 participants, divided equally between the two intervention groups. It is conducted at Sahlgrenska University Hospital, involving a multidisciplinary collaboration between the Oncology Department and the Orthopedic Technology Department .
Step 1: Diagnosis and Assessment Patients with chemotherapy-induced peripheral neuropathy in the lower extremities (feet) following breast cancer treatment will be assessed using a standardized grading system based on the Common Terminology Criteria for Adverse Events as well as a symptom questionnaire. Patients will also complete self-reported quality-of-life assessments as well as the EQ-5D scale and undergo 3D foot scanning to measure foot morphology and structural differences compared to the general population. Medical records will be reviewed to collect demographic and clinical variables (age, cancer status, chemotherapy regimen, comorbidities, smoking status, Body Mass Index).
Step 2: Orthopedic Interventions
Patients will be randomly assigned to one of two intervention groups:
Group 1: Receives customized orthopedic insoles and shoes, the current standard treatment for diabetic neuropathy.
Group 2: Receives a silicone orthosis, a novel sock-like support designed for indoor use.
All participants will receive guidance on footwear selection and be provided with seamless socks to minimize pressure on sensitive areas.
All patients will also be examined with
- D-Foot: A validated and reliable instrument for structured foot examination, primarily used in diabetic foot assessments.
- 3D foot scanning (Volumental scanner): Provides highly accurate foot measurements with a ±1 mm error margin.
Step 3: Activity Monitoring
To objectively assess mobility and functional changes, patients will wear an activity tracker (Active Pal) attached to their leg using skin-friendly tape for two weeks. The device records data on:
- Time spent sitting, standing, walking, or lying down.
- Step count and movement patterns. Patients in the silicone orthosis group will also maintain a daily usage diary to document how often they wear the device.
Step 4: Follow-Up and Outcome Evaluation
Follow-up assessments will occur 3-6 weeks post-intervention, conducted by oncology nurse or doctor via:
- Repeat symptom grading (CTCAE).
- Self-reported questionnaires on foot health and quality of life.
- Semistructured interviews evaluating patients' experiences with their assigned intervention.
Interviews will explore:
- Perceived symptom relief and comfort.
- Impact on daily activities and mobility.
- Satisfaction with the provided intervention.
- The follow-up can be conducted in person, via phone, or digitally and is estimated to take approximately 45 minutes.
Scientific Questions
The study aims to answer the following key research questions:
- What is the prevalence and severity of chemotherapy-induced peripheral neuropathy in the feet among the patients?
- How does chemotherapy-induced peripheral neuropathy affect self-reported quality of life (EQ-5D scores)?
- What is the foot status (e.g., structural and functional characteristics) in affected patients?
- Are there foot morphology differences between chemotherapy-induced peripheral neuropathy patients and the general female population?
- Does the type of orthopedic aid influence activity levels and mobility?
- How does chemotherapy-induced peripheral neuropathy impact patients' daily lives?
- Are there differences in patient experience and perceived effectiveness between the two orthopedic interventions?
Expected Impact
If successful, this study will:
- Provide new insights into the effectiveness of orthopedic aids for chemotherapy-induced peripheral neuropathy -related foot symptoms.
- Establish a structured assessment process for chemotherapy-induced peripheral neuropathy in oncology rehabilitation.
- Improve patient quality of life by offering evidence-based interventions for symptom relief.
- Lay the groundwork for a larger randomized controlled trial to confirm findings and influence future clinical guidelines.
By bridging the gap between oncology and orthopedic technology, this project aims to enhance rehabilitation strategies for cancer survivors dealing with long-term neuropathic complications.
- Conditions
- Polyneuropathy, Breast Cancer
- Being tested
- Silicone orthosis, Standard Treatment
- Keywords
- Chemotherapy-Induced Peripheral Neuropathy (CIPN), Oncology Rehabilitation, Orthopedic Intervention, Breast Cancer, Orthopedic Insoles
- Medical subject headings
- Polyneuropathies, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silicone orthosisDevice
in addition to standard treatment, shoe and insole treatment, a new type of treatment for CIPN is being evaluated, a silicone orthosis.The silicone orthosis consists of a half-sock designed for indoor use.
The participants feet are examined, and the foot shape is scanned barefoot using a three-dimensional foot scanner from Volumental. This is performed to use a basis for manufacturing individual silicone orthoses. Activity measurement with an activity sensor, attached to the thigh with tape, is planned for two weeks after receiving the assistive device.
Participants who receive a silicone orthosis are asked to keep a diary of how much they have used it. The follow-up takes place at the Oncology Department 3-6 weeks after the participant has received the assistive device.
Standard TreatmentDevice
The standard treatment is that patients are provided with customized insoles and shoes. Foot status is recorded during the orthopedic technical assessment at OTA, identifying signs of neuropathy, impaired blood circulation, foot deformities, and skin pathologies. A modified version of the validated D-Foot instrument is used to assess the risk of foot ulcers, especially in diabetic patients. The evaluation also includes lower extremity function, gait abnormalities, and existing footwear and insoles.
Differences in foot anthropometry are compared between scanned foot measurements of the study group and those of a control group representing a female Swedish normal population.
ActivePal is a reliable method for measuring and classifying activity levels. Activity measurement is conducted over two weeks.
| Study group | Role | What they receive |
|---|---|---|
| Standard orthopedic treatment | Active comparator | Patients provided with customized shoes and insoles for outdoor use Receives: Device: Standard Treatment |
| Silicone orthose | Experimental | Patients provided with customized shoes and insoles for outdoor use + a specialized sock for indoor use. Receives: Device: Silicone orthosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in foot neuropathy grade after 3-6 weeks of using the silicone orthosis.
Neuropathy severity will be assessed using the NCI-CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events) version 5.0, a standardized tool for grading adverse events related to cancer treatment, including chemotherapy-induced peripheral neuropathy (CIPN).
CIPN is classified into five grades based on motor, sensory, and autonomic symptoms:
Grade 1 (Mild): Asymptomatic or mild symptoms with no significant impact on daily activities.
Grade 2 (Moderate): Symptoms affecting daily activities but not requiring intervention.
Grade 3 (Severe): Symptoms severely limiting self-care and daily functions. Grade 4 (Life-threatening): Disabling symptoms requiring urgent intervention. Grade 5 (Fatal): Death related to adverse effects. Higher grades indicate more severe neuropathy and are used to monitor patient safety, adjust treatments, and evaluate drug toxicity in clinical oncology settings.
Measured: At baseline and after three to six weeks after treatment initiation
Change in Change in physical activity level after 3-6 weeks of using the silicone orthosis.
The device records movement patterns and classifies activity into three main categories:
Sedentary time (e.g., sitting or lying down) Standing time Stepping time (walking or other movement) The data is collected over a period of two weeks, allowing researchers to analyze changes in mobility and activity levels. The first few days serve as an adaptation phase, after which the measurements are expected to reflect habitual daily activity. The digital activity data is often combined with patient diaries to provide a more comprehensive analysis of movement patterns and intervention effects.
Measured: During two weeks after initiation of treatment
Change in foot neuropathy symptoms after 3-6 weeks of using the silicone orthosis.
The modified CIPN20 questionnaire is a tool for assessing chemotherapy-induced peripheral neuropathy symptoms and their impact on daily life. It consists of 20 items, covering sensory (9 items), motor (8 items), and autonomic (3 items) domains.
Each item is rated on a 5-point Likert scale:
0 = Not at all
- = A little
- = Somewhat
- = Quite a bit
- = Very much Higher scores indicate more severe symptoms and functional impairment. The scores can be analyzed separately for each domain or as a total CIPN burden, making the questionnaire useful for monitoring symptom progression and evaluating treatment effects.
Measured: At baseline and after 3-6 weeks after initiation of treatment.
Secondary outcomes (3)
Change in self reported quality of life in patients with foot neuropathy after 3-6 weeks of using the silicone orthosis.
The EQ-5D is a standardized tool for measuring health-related quality of life (HRQoL). It provides a simple, generic measure of health status and is used in both clinical and research settings to assess treatment outcomes and patient well-being.
Structure and Scoring The EQ-5D consists of five dimensions, each rated on a 5-point scale: Mobility (ability to walk) Self-care (ability to wash/dress oneself) Usual activities (work, study, household tasks, etc.) Pain/discomfort Anxiety/depression Each dimension is scored from 1 (no problems) to 5 (extreme problems), generating a unique health profile that can be converted into a single index score using country-specific value sets. Additionally, EQ-5D includes a Visual Analog Scale (VAS), where patients rate their overall health from 0 (worst imaginable health) to 100 (best imaginable health).
The EQ-5D is useful for tracking changes in health status over time, comparing treatment effects, and informing health economic ev
Measured: At enrollment and after three to six weeks after treatment initiation
Comparisons of foot status based on a structured foot examination.
Foot status is recorded during the orthopedic technical assessment. The examination identifies signs of neuropathy, impaired blood circulation, foot deformities, skin pathologies, and a history of ulcers or amputations using a modified version of D-Foot. D-Foot is a validated and reliable instrument for structured foot examinations, primarily used to identify diabetic patients at increased risk of foot ulcers. In addition to foot status, lower extremity function, gait abnormalities, and existing footwear and insoles are documented
Measured: The comparison is based on a one-time examination at enrollment.
Differences in foot anthropometry between study group and a control group representing a female Swedish normal population
Differences in foot anthropometry are compared between scanned foot measurements of the study group and those of a control group representing a female Swedish normal population. Based on 3D foot scanning of the participant's feet, measurements such as foot length, foot width, and toe height are obtained. The Volumental scanner has a measurement error margin of 1 mm.
Measured: The comparison is based on a one-time examination at enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2025
- Study start1 Dec 2024
- Primary completionJun 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PolyneuropathyStudies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe 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
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Ulla Hellstrand Tang, Orthopedic engineer, Principal investigator, Vastragotaland regionen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06904989
- Sponsor's protocol ID
- 2024-05490-01
- Acronym
- FOTNEV
- Status last verified
- Nov 2024
- First submitted
- 10 Mar 2025
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation and Evaluation of a New Cancer Rehabilitation Process for the Assessment and Treatment of Chemotherapy-Induced Foot Neuropathy - A Collaborative Project Between Oncology Clinic and Orthopedic Technology Department 2.0.
- ClinicalTrials.gov ID
- NCT06904989
- Acronym / sponsor ID
- FOTNEV / 2024-05490-01
- Conditions
- Polyneuropathy, Breast Cancer
- Keywords
- Chemotherapy-Induced Peripheral Neuropathy (CIPN), Oncology Rehabilitation, Orthopedic Intervention, Breast Cancer, Orthopedic Insoles
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 1 Apr 2025 (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 study is to evaluate a new process for assessing and alleviating chemotherapy-induced peripheral neuropathy in the feet in patients treated with chemotherapy for early stage breast cancer. It will also compare two orthopedic interventions for symptom relief. The main questions it aims to answer are:
Can an orthopedic silicone orthosis reduce chemotherapy-induced peripheral neuropathy symptoms in the feet? How does the effectiveness of the silicone orthosis compare to standard orthopedic treatment with insoles and shoes?
Participants will:
Use either a silicone orthosis or standard orthopedic treatment Have contact with the clinic for assessments and follow-ups Report their symptoms and functional improvements over time
Detailed description
Background and Rationale
This study aims to develop and evaluate a structured multidisciplinary rehabilitation process for assessing and managing chemotherapy-induced peripheral neuropathy in the feet. The project establishes a new collaboration between the Oncology Department and the Department of Orthopedic Technology at Sahlgrenska University Hospital, integrating an orthopedic approach into cancer rehabilitation.
Chemotherapy-induced peripheral neuropathy is a common side effect of chemotherapy, affecting 50-90% of patients undergoing cancer treatment. Symptoms such as numbness, tingling, pain, and sensory loss in the feet can lead to chronic discomfort, impaired balance, and reduced quality of life. Despite its prevalence, there are no standardized guidelines for grading or managing chemotherapy-induced peripheral neuropathy within rehabilitation. Additionally, structured follow-up for chemotherapy-induced peripheral neuropathy after chemotherapy is lacking in Sweden, and there are limited effective treatment options available.
This research project aims to develop a structured process for assessing and managing chemotherapy-induced peripheral neuropathy in the feet and to evaluate two orthopedic interventions:
- Current standard treatment - customized insoles and orthopedic shoes.
- A novel intervention - a silicone orthosis, designed as a soft, sock-like device for indoor use.
Although silicone orthoses have been introduced in limited clinical settings in Sweden, their effectiveness for chemotherapy-induced peripheral neuropathy remains untested. This study seeks to evaluate whether this new intervention can alleviate symptoms and improve mobility and quality of life for breast cancer patients experiencing chemotherapy-induced peripheral neuropathy .
Study Objectives
The overall aim is to establish and evaluate a new process for assessing and alleviating symptoms in the feet through orthopedic technology. Specifically, the study will:
- Compare the effectiveness of two orthopedic interventions (custom insoles vs. silicone orthosis).
- Investigate patient-reported outcomes regarding symptom relief, quality of life, and functional mobility.
Study Design and Methodology The study consists of a pilot phase with, followed by a potential randomized controlled trial if preliminary results are promising. This pilot study will include 40 participants, divided equally between the two intervention groups. It is conducted at Sahlgrenska University Hospital, involving a multidisciplinary collaboration between the Oncology Department and the Orthopedic Technology Department .
Step 1: Diagnosis and Assessment Patients with chemotherapy-induced peripheral neuropathy in the lower extremities (feet) following breast cancer treatment will be assessed using a standardized grading system based on the Common Terminology Criteria for Adverse Events as well as a symptom questionnaire. Patients will also complete self-reported quality-of-life assessments as well as the EQ-5D scale and undergo 3D foot scanning to measure foot morphology and structural differences compared to the general population. Medical records will be reviewed to collect demographic and clinical variables (age, cancer status, chemotherapy regimen, comorbidities, smoking status, Body Mass Index).
Step 2: Orthopedic Interventions
Patients will be randomly assigned to one of two intervention groups:
Group 1: Receives customized orthopedic insoles and shoes, the current standard treatment for diabetic neuropathy.
Group 2: Receives a silicone orthosis, a novel sock-like support designed for indoor use.
All participants will receive guidance on footwear selection and be provided with seamless socks to minimize pressure on sensitive areas.
All patients will also be examined with
- D-Foot: A validated and reliable instrument for structured foot examination, primarily used in diabetic foot assessments.
- 3D foot scanning (Volumental scanner): Provides highly accurate foot measurements with a ±1 mm error margin.
Step 3: Activity Monitoring
To objectively assess mobility and functional changes, patients will wear an activity tracker (Active Pal) attached to their leg using skin-friendly tape for two weeks. The device records data on:
- Time spent sitting, standing, walking, or lying down.
- Step count and movement patterns. Patients in the silicone orthosis group will also maintain a daily usage diary to document how often they wear the device.
Step 4: Follow-Up and Outcome Evaluation
Follow-up assessments will occur 3-6 weeks post-intervention, conducted by oncology nurse or doctor via:
- Repeat symptom grading (CTCAE).
- Self-reported questionnaires on foot health and quality of life.
- Semistructured interviews evaluating patients' experiences with their assigned intervention.
Interviews will explore:
- Perceived symptom relief and comfort.
- Impact on daily activities and mobility.
- Satisfaction with the provided intervention.
- The follow-up can be conducted in person, via phone, or digitally and is estimated to take approximately 45 minutes.
Scientific Questions
The study aims to answer the following key research questions:
- What is the prevalence and severity of chemotherapy-induced peripheral neuropathy in the feet among the patients?
- How does chemotherapy-induced peripheral neuropathy affect self-reported quality of life (EQ-5D scores)?
- What is the foot status (e.g., structural and functional characteristics) in affected patients?
- Are there foot morphology differences between chemotherapy-induced peripheral neuropathy patients and the general female population?
- Does the type of orthopedic aid influence activity levels and mobility?
- How does chemotherapy-induced peripheral neuropathy impact patients' daily lives?
- Are there differences in patient experience and perceived effectiveness between the two orthopedic interventions?
Expected Impact
If successful, this study will:
- Provide new insights into the effectiveness of orthopedic aids for chemotherapy-induced peripheral neuropathy -related foot symptoms.
- Establish a structured assessment process for chemotherapy-induced peripheral neuropathy in oncology rehabilitation.
- Improve patient quality of life by offering evidence-based interventions for symptom relief.
- Lay the groundwork for a larger randomized controlled trial to confirm findings and influence future clinical guidelines.
By bridging the gap between oncology and orthopedic technology, this project aims to enhance rehabilitation strategies for cancer survivors dealing with long-term neuropathic complications.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard orthopedic treatment | Active comparator | Device: Standard TreatmentPatients provided with customized shoes and insoles for outdoor use |
| Silicone orthose | Experimental | Device: Silicone orthosisPatients provided with customized shoes and insoles for outdoor use + a specialized sock for indoor use. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with breast cancer receiving treatment at the Oncology Department, Sahlgrenska University Hospital (SU).
- Have undergone treatment with taxanes.
- Aged 18 years or older.
- Able to understand spoken and written Swedish.
- Patients who can ambulate with or without assistive walking devices.
Key exclusion criteria (2 listed)
- Bilateral amputation at the thigh level.
- Previously diagnosed neurological disease or neurological impairment affecting the feet.
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 |
|---|---|---|
| Silicone orthosisin addition to standard treatment, shoe and insole treatment, a new type of treatment for CIPN is being evaluated, a silicone orthosis.The silicone orthosis consists of a half-sock designed for indoor use. The participants feet are examined, and the foot shape is scanned barefoot using a three-dimensional foot scanner from Volumental. This is performed to use a basis for manufacturing individual silicone orthoses. Activity measurement with an activity sensor, attached to the thigh with tape, is planned for two weeks after receiving the assistive device. Participants who receive a silicone orthosis are asked to keep a diary of how much they have used it. The follow-up takes place at the Oncology Department 3-6 weeks after the participant has received the assistive device. | Device | Silicone orthose |
| Standard TreatmentThe standard treatment is that patients are provided with customized insoles and shoes. Foot status is recorded during the orthopedic technical assessment at OTA, identifying signs of neuropathy, impaired blood circulation, foot deformities, and skin pathologies. A modified version of the validated D-Foot instrument is used to assess the risk of foot ulcers, especially in diabetic patients. The evaluation also includes lower extremity function, gait abnormalities, and existing footwear and insoles. Differences in foot anthropometry are compared between scanned foot measurements of the study group and those of a control group representing a female Swedish normal population. ActivePal is a reliable method for measuring and classifying activity levels. Activity measurement is conducted over two weeks. | Device | Standard orthopedic treatment |
Primary outcome
Change in foot neuropathy grade after 3-6 weeks of using the silicone orthosis.
Time frame: At baseline and after three to six weeks after treatment initiation
Neuropathy severity will be assessed using the NCI-CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events) version 5.0, a standardized tool for grading adverse events related to cancer treatment, including chemotherapy-induced peripheral neuropathy (CIPN). CIPN is classified into five grades based on motor, sensory, and autonomic symptoms: Grade 1 (Mild): Asymptomatic or mild symptoms with no significant impact on daily activities. Grade 2 (Moderate): Symptoms affecting daily activities but not requiring intervention. Grade 3 (Severe): Symptoms severely limiting self-care and daily functions. Grade 4 (Life-threatening): Disabling symptoms requiring urgent intervention. Grade 5 (Fatal): Death related to adverse effects. Higher grades indicate more severe neuropathy and are used to monitor patient safety, adjust treatments, and evaluate drug toxicity in clinical oncology settings.
Change in Change in physical activity level after 3-6 weeks of using the silicone orthosis.
Time frame: During two weeks after initiation of treatment
The device records movement patterns and classifies activity into three main categories: Sedentary time (e.g., sitting or lying down) Standing time Stepping time (walking or other movement) The data is collected over a period of two weeks, allowing researchers to analyze changes in mobility and activity levels. The first few days serve as an adaptation phase, after which the measurements are expected to reflect habitual daily activity. The digital activity data is often combined with patient diaries to provide a more comprehensive analysis of movement patterns and intervention effects.
Change in foot neuropathy symptoms after 3-6 weeks of using the silicone orthosis.
Time frame: At baseline and after 3-6 weeks after initiation of treatment.
The modified CIPN20 questionnaire is a tool for assessing chemotherapy-induced peripheral neuropathy symptoms and their impact on daily life. It consists of 20 items, covering sensory (9 items), motor (8 items), and autonomic (3 items) domains. Each item is rated on a 5-point Likert scale: 0 = Not at all 1. = A little 2. = Somewhat 3. = Quite a bit 4. = Very much Higher scores indicate more severe symptoms and functional impairment. The scores can be analyzed separately for each domain or as a total CIPN burden, making the questionnaire useful for monitoring symptom progression and evaluating treatment effects.
3 secondary outcomes
Change in self reported quality of life in patients with foot neuropathy after 3-6 weeks of using the silicone orthosis.
Time frame: At enrollment and after three to six weeks after treatment initiation
Comparisons of foot status based on a structured foot examination.
Time frame: The comparison is based on a one-time examination at enrollment.
Differences in foot anthropometry between study group and a control group representing a female Swedish normal population
Time frame: The comparison is based on a one-time examination at enrollment.
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 1 Apr 2025.
- 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.
Ulla Hellstrand Tang, Orthopedic engineer principal investigator
Vastragotaland regionen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Silicone orthosis and Standard Treatment in people with Polyneuropathy and Breast Cancer, run by Vastra Gotaland Region at 1 site in Sweden.
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 2 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 1 Apr 2025. 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 Sweden. 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 Malin Rydholm, MD (0046705568678, malin.rydholm@vgregion.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in foot neuropathy grade after 3-6 weeks of using the silicone orthosis. (time frame: At baseline and after three to six weeks after treatment initiation). 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?
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 1 Apr 2025.