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.