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.

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Sweden
Sahlgrenska University Hospital
RECRUITING
Gothenburg
Contact Information
Primary
Malin Rydholm, MD
malin.rydholm@vgregion.se
0046705568678
Backup
Ulla Hellstrand Tang, Orthopedic engineer
ulla.tang@vgregion.se
+46706397913
Time Frame
Start Date: 2024-12-01
Estimated Completion Date: 2025-10
Participants
Target number of participants: 40
Treatments
Active_comparator: Standard orthopedic treatment
Patients provided with customized shoes and insoles for outdoor use
Experimental: Silicone orthose
Patients provided with customized shoes and insoles for outdoor use + a specialized sock for indoor use.
Related Therapeutic Areas
Sponsors
Leads: Vastra Gotaland Region

This content was sourced from clinicaltrials.gov