Clinical trial NCT06904989: A New Cancer Rehabilitation Process for Chemotherapy-Induced Foot Neuropathy Using Orthopedic Devices
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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Polyneuropathy
Breast Cancer
Keywords: Chemotherapy-Induced Peripheral Neuropathy (CIPN)
Oncology Rehabilitation
Orthopedic Intervention
Breast Cancer
Orthopedic Insoles
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
First posted: 2025-04-01
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Bilateral amputation at the thigh level.
* Previously diagnosed neurological disease or neurological impairment affecting the feet.

Primary outcomes:
measure: Change in foot neuropathy grade after 3-6 weeks of using the silicone orthosis.
timeFrame: At baseline and after three to six weeks after treatment initiation
measure: Change in Change in physical activity level after 3-6 weeks of using the silicone orthosis.
timeFrame: During two weeks after initiation of treatment
measure: Change in foot neuropathy symptoms after 3-6 weeks of using the silicone orthosis.
timeFrame: At baseline and after 3-6 weeks after initiation of treatment.
Secondary outcomes:
measure: Change in self reported quality of life in patients with foot neuropathy after 3-6 weeks of using the silicone orthosis.
timeFrame: At enrollment and after three to six weeks after treatment initiation
measure: Comparisons of foot status based on a structured foot examination.
timeFrame: The comparison is based on a one-time examination at enrollment.
measure: Differences in foot anthropometry between study group and a control group representing a female Swedish normal population
timeFrame: The comparison is based on a one-time examination at enrollment.
Other outcomes:
measure: Patients' experiences using orthotic devices in order to relieve symptoms of CIPN in the feet after treatment for early-stage breast cancer.
timeFrame: A one-time occasion 6-10 weeks after enrollment.
measure: Patients' experiences of living with CIPN after treatment for early-stage breast cancer
timeFrame: A single assessment conducted before the start of treatment
Locations:
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
Study officials:
affiliation: Vastragotaland regionen
name: Ulla Hellstrand Tang, Orthopedic engineer
role: PRINCIPAL_INVESTIGATOR
References: