Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06904989

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

Led by Vastra Gotaland Region · Updated on 2025-04-01

40

Participants Needed

1

Research Sites

43 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
  • Patients who can ambulate with or without assistive walking devices
  • CTCAE grading above 2 at a medical visit after completing treatment
Not Eligible

You will not qualify if you...

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

AI-Screening

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Trial Site Locations

Total: 1 location

1

Sahlgrenska University Hospital

Gothenburg, Sweden, 413 45

Actively Recruiting

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Research Team

M

Malin Rydholm, MD

CONTACT

U

Ulla Hellstrand Tang, Orthopedic engineer

CONTACT

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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