New orthopedic devices for treating foot neuropathy in breast cancer patients
Official title: 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.
Run by Vastra Gotaland Region · NCT06904989 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Vastra Gotaland Region Government |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Gothenburg) |
| Status | Recruiting |
| Started | December 1, 2024 |
| Main results expected | June 2025 |
| Study ends | October 2025 |
| Registry record updated | April 1, 2025 |
| Trial ID | NCT06904989 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are breast cancer patients aged 18 and older who have received taxane treatment and are experiencing significant foot neuropathy.
✕Probably not a fit
Patients with bilateral thigh amputations or pre-existing neurological diseases affecting the feet may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While similar approaches have been explored, this specific intervention using silicone orthoses for chemotherapy-induced peripheral neuropathy is relatively novel.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Gyrotonic exercise for elders with breast cancer and Behcet disease
We’re testing whether a gyrotonic exercise program helps older people who have both Behcet disease and breast cancer.
-
PECS II vs SPSIP nerve blocks for pain after mastectomy
This study tests whether two ultrasound-guided nerve blocks (PECS II and SPSIP) differ in how much opioid patients need after mastectomy.
-
CG-7321: a first-in-human test in advanced solid tumors
We’re testing CG-7321 alone and with fulvestrant to see if it’s safe and tolerable in adults with advanced solid tumors.
-
Compare a new endoscopy-assisted breast-conserving surgery with the usual approach
This study tests whether a new endoscopy-assisted breast-conserving technique can provide similar or better cosmetic outcomes and safety compared with conventional breast-conserving surgery in women with early breast cancer who want to preserve their breast.
-
Different skin care approaches to prevent skin reactions after mastectomy radiation
This study tests three standard skin care methods to see which best prevents radiation dermatitis in people who had a mastectomy and are receiving post-mastectomy radiation therapy.
-
3D Heart Strain to Detect Early Cardiotoxicity in Cancer Therapy
This study tests whether 3D echocardiography can detect early heart damage from cancer treatments like anthracyclines or HER2-targeted therapy better than standard 2D methods.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.