New orthopedic devices for treating foot neuropathy in breast cancer patients
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.
This study tests a new foot device to see if it can help breast cancer patients with nerve pain caused by chemotherapy feel better compared to regular shoe inserts and orthopedic treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Vastra Gotaland Region Government |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Gothenburg) |
| Trial ID | NCT06904989 on ClinicalTrials.gov |
What this trial studies
This clinical study evaluates a new rehabilitation process aimed at alleviating chemotherapy-induced peripheral neuropathy in the feet of patients treated for early-stage breast cancer. It compares the effectiveness of a silicone orthosis against standard orthopedic treatments like insoles and shoes. Participants will report their symptoms and functional improvements over time while receiving either intervention. The study seeks to establish a structured approach to managing this common side effect of chemotherapy, which significantly impacts patients' quality of life.
Who should consider this trial
Good fit: Ideal candidates are breast cancer patients aged 18 and older who have received taxane treatment and are experiencing significant foot neuropathy.
Not a fit: Patients with bilateral thigh amputations or pre-existing neurological diseases affecting the feet may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide effective relief from foot neuropathy symptoms for breast cancer patients undergoing chemotherapy.
How similar studies have performed: While similar approaches have been explored, this specific intervention using silicone orthoses for chemotherapy-induced peripheral neuropathy is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Gothenburg
- Sahlgrenska University Hospital — Gothenburg, Sweden (Recruiting)
Study contacts
- Principal investigator: Ulla Hellstrand Tang, Orthopedic engineer — Vastragotaland regionen
- Study coordinator: Malin Rydholm, MD
- Email: malin.rydholm@vgregion.se
- Phone: 0046705568678
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.