Clinical trial · Interventional
A New Cancer Rehabilitation Process for Chemotherapy-Induced Foot Neuropathy Using Orthopedic Devices
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Polyneuropathy | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Silicone orthosis | Device | — | UNRESOLVED |
| Standard Treatment | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Standard orthopedic treatment
- description
- Patients provided with customized shoes and insoles for outdoor use
- interventionNames
- Device: Standard Treatment
- type
- EXPERIMENTAL
- label
- Silicone orthose
- description
- Patients provided with customized shoes and insoles for outdoor use + a specialized sock for indoor use.
- interventionNames
- Device: Silicone orthosis
Primary outcomes (3)
- measure
- Change in foot neuropathy grade after 3-6 weeks of using the silicone orthosis.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available