RecruitingNot Applicable

A New Cancer Rehabilitation Process for Chemotherapy-Induced Foot Neuropathy Using Orthopedic Devices

Sweden40 participantsStarted 2024-12-01

Plain-language 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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Change in Change in physical activity level after 3-6 weeks of using the silicone orthosis.

Timeframe: During two weeks after initiation of treatment

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.

Trial details

NCT IDNCT06904989

SponsorVastra Gotaland Region

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2025-06

Contact for this trial

Malin Rydholm, MD

0046705568678 malin.rydholm@vgregion.se

View on ClinicalTrials.gov More Polyneuropathy trials