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

NCT06904989 | Recruiting

• 1 other identifier: 2024-05490-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Polyneuropathy; Breast Cancer

Keywords

Chemotherapy-Induced Peripheral Neuropathy (CIPN); Oncology Rehabilitation; Orthopedic Intervention; Breast Cancer; Orthopedic Insoles

Outcome Measures

Primary Outcomes (3)

• Change in foot neuropathy grade after 3-6 weeks of using the silicone orthosis.

  Neuropathy severity will be assessed using the NCI-CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events) version 5.0, a standardized tool for grading adverse events related to cancer treatment, including chemotherapy-induced peripheral neuropathy (CIPN). CIPN is classified into five grades based on motor, sensory, and autonomic symptoms: Grade 1 (Mild): Asymptomatic or mild symptoms with no significant impact on daily activities. Grade 2 (Moderate): Symptoms affecting daily activities but not requiring intervention. Grade 3 (Severe): Symptoms severely limiting self-care and daily functions. Grade 4 (Life-threatening): Disabling symptoms requiring urgent intervention. Grade 5 (Fatal): Death related to adverse effects. Higher grades indicate more severe neuropathy and are used to monitor patient safety, adjust treatments, and evaluate drug toxicity in clinical oncology settings.

  At baseline and after three to six weeks after treatment initiation

• Change in Change in physical activity level after 3-6 weeks of using the silicone orthosis.

  The device records movement patterns and classifies activity into three main categories: Sedentary time (e.g., sitting or lying down) Standing time Stepping time (walking or other movement) The data is collected over a period of two weeks, allowing researchers to analyze changes in mobility and activity levels. The first few days serve as an adaptation phase, after which the measurements are expected to reflect habitual daily activity. The digital activity data is often combined with patient diaries to provide a more comprehensive analysis of movement patterns and intervention effects.

  During two weeks after initiation of treatment

• Change in foot neuropathy symptoms after 3-6 weeks of using the silicone orthosis.

  The modified CIPN20 questionnaire is a tool for assessing chemotherapy-induced peripheral neuropathy symptoms and their impact on daily life. It consists of 20 items, covering sensory (9 items), motor (8 items), and autonomic (3 items) domains. Each item is rated on a 5-point Likert scale: 0 = Not at all 1. = A little 2. = Somewhat 3. = Quite a bit 4. = Very much Higher scores indicate more severe symptoms and functional impairment. The scores can be analyzed separately for each domain or as a total CIPN burden, making the questionnaire useful for monitoring symptom progression and evaluating treatment effects.

  At baseline and after 3-6 weeks after initiation of treatment.

Secondary Outcomes (3)

• Change in self reported quality of life in patients with foot neuropathy after 3-6 weeks of using the silicone orthosis.

  At enrollment and after three to six weeks after treatment initiation

• Comparisons of foot status based on a structured foot examination.

  The comparison is based on a one-time examination at enrollment.

• Differences in foot anthropometry between study group and a control group representing a female Swedish normal population

  The comparison is based on a one-time examination at enrollment.

Other Outcomes (2)

• Patients' experiences using orthotic devices in order to relieve symptoms of CIPN in the feet after treatment for early-stage breast cancer.

  A one-time occasion 6-10 weeks after enrollment.

• Patients' experiences of living with CIPN after treatment for early-stage breast cancer

  A single assessment conducted before the start of treatment

Study Arms (2)

Standard orthopedic treatment

ACTIVE COMPARATOR

Patients provided with customized shoes and insoles for outdoor use

Device: Standard Treatment

Silicone orthose

EXPERIMENTAL

Patients provided with customized shoes and insoles for outdoor use + a specialized sock for indoor use.

Device: Silicone orthosis

Interventions

Silicone orthosis DEVICE

in addition to standard treatment, shoe and insole treatment, a new type of treatment for CIPN is being evaluated, a silicone orthosis.The silicone orthosis consists of a half-sock designed for indoor use. The participants feet are examined, and the foot shape is scanned barefoot using a three-dimensional foot scanner from Volumental. This is performed to use a basis for manufacturing individual silicone orthoses. Activity measurement with an activity sensor, attached to the thigh with tape, is planned for two weeks after receiving the assistive device. Participants who receive a silicone orthosis are asked to keep a diary of how much they have used it. The follow-up takes place at the Oncology Department 3-6 weeks after the participant has received the assistive device.

Silicone orthose

Standard Treatment DEVICE

The standard treatment is that patients are provided with customized insoles and shoes. Foot status is recorded during the orthopedic technical assessment at OTA, identifying signs of neuropathy, impaired blood circulation, foot deformities, and skin pathologies. A modified version of the validated D-Foot instrument is used to assess the risk of foot ulcers, especially in diabetic patients. The evaluation also includes lower extremity function, gait abnormalities, and existing footwear and insoles. Differences in foot anthropometry are compared between scanned foot measurements of the study group and those of a control group representing a female Swedish normal population. ActivePal is a reliable method for measuring and classifying activity levels. Activity measurement is conducted over two weeks.

Standard orthopedic treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Vastra Gotaland Region: lead

Study Sites (1)

Sahlgrenska University Hospital

Gothenburg, 413 45, Sweden

RECRUITING

MeSH Terms

Conditions

Polyneuropathies; Breast Neoplasms

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Ulla Hellstrand Tang, Orthopedic engineer

  Vastragotaland regionen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Malin Rydholm, MD

CONTACT

0046705568678; malin.rydholm@vgregion.se

Ulla Hellstrand Tang, Orthopedic engineer

CONTACT

+46706397913; ulla.tang@vgregion.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2025
• First Posted: April 1, 2025
• Study Start: December 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: October 1, 2025
• Last Updated: April 1, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)