Actively Recruiting
Implementation and Evaluation of a New Cancer Rehabilitation Process for Chemotherapy-Induced Foot Neuropathy Using Orthopedic Devices in Breast Cancer Patients
Led by Vastra Gotaland Region · Updated on 2025-04-01
40
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new rehabilitation process to assess and relieve chemotherapy-induced peripheral neuropathy in the feet of patients treated for early-stage breast cancer. This study compares two orthopedic supports: a standard treatment using customized insoles and shoes, and a novel silicone orthosis designed as a soft, sock-like device for indoor use. The goal is to understand if the silicone orthosis can reduce symptoms and improve function compared to standard treatment. Participants will be randomly assigned to receive either the customized insoles and shoes or the silicone orthosis along with the standard treatment. The study involves initial assessments including symptom grading, foot health questionnaires, quality of life scales, and 3D foot scanning. Activity levels will be tracked using an activity sensor worn on the leg for two weeks. Participants using the silicone orthosis will keep a diary of device usage. Follow-ups occur 3 to 6 weeks after starting the intervention to evaluate symptom changes and patient experiences. During the study, participants will undergo foot examinations and complete questionnaires about their symptoms, foot health, and quality of life. Mobility and activity patterns will be monitored objectively with activity trackers. Follow-up may be conducted in person, by phone, or digitally, lasting about 45 minutes. The main outcomes include changes in neuropathy symptoms and physical activity after 3 to 6 weeks of using the orthopedic devices. This research aims to improve rehabilitation care for breast cancer survivors experiencing foot neuropathy from chemotherapy.
CONDITIONS
Brief Title
A New Cancer Rehabilitation Process for Chemotherapy-Induced Foot Neuropathy Using Orthopedic Devices
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with breast cancer receiving treatment at the Oncology Department, Sahlgrenska University Hospital
- Have undergone treatment with taxanes
- Aged 18 years or older
- Able to understand spoken and written Swedish
- Able to walk with or without assistive devices
- CTCAE grading above 2 after completing treatment
You will not qualify if you...
- Bilateral amputation at the thigh level
- Previously diagnosed neurological disease or neurological impairment affecting the feet
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 week
Participants undergo a detailed foot assessment including symptom grading, quality-of-life questionnaires, structured foot examination, and 3D foot scanning. Based on random assignment, participants receive either customized orthopedic insoles and shoes or a silicone orthosis for indoor use, along with guidance on footwear and seamless socks.
1 visit (in-person) for assessment and device fitting
Duration - 2 weeks
Participants wear an activity tracker on their leg for two weeks to monitor mobility and functional changes. Those in the silicone orthosis group also keep a daily diary of device usage.
Continuous monitoring over 2 weeks
Duration - 3 to 6 weeks
Follow-up assessments are conducted 3 to 6 weeks after receiving the orthopedic device. Participants undergo repeat symptom grading, complete self-reported foot health and quality-of-life questionnaires, and participate in semi-structured interviews to discuss their experiences and satisfaction with the intervention.
1 follow-up visit (in-person, phone, or digital) lasting about 45 minutes
Trial Site Locations
Total: 1 location
1
Sahlgrenska University Hospital
Gothenburg, Sweden, 413 45
Actively Recruiting
Research Team
M
Malin Rydholm, MD
U
Ulla Hellstrand Tang, Orthopedic engineer
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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