Peripheral neuropathy, peripheral nerve disease, peripheral neuralgia, chemotherapy induced peripheral neuropathy, CIPN Neuropathy
Conditions
Interventions
The multimodal exercise intervention consists of a 12-week exercise program including: 
Two supervised exercise sessions per week of 60 minutes delivered by a physiotherapist. 
Immediate intervention armThe multimodal exercise intervention consists of a 12-week exercise program including: 
A variable amount of sessions in 12 weeks depending on patients’ needs (£1/week, consisting of 30-60 minutes) on task specific exercise delivered by an occupational therapist.One weekly 20-minute tail
Daily hand or foot exercises, dependent on patients’ needs 
The supervised exercise sessions at the physiotherapist will consist of balance, resistance and continuous aerobic exercises. Each exercise session will start with a brief warming-up and end with a co
Sponsors
Antoni van Leeuwenhoek (AVL)
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria:= 18 years of age,Completed treatment with neurotoxic systemic cancer treatment at least 6 months ago,Experience mild/moderate/severe CIPN symptoms, that arose or aggravated during or after the last treatment episode of neurotoxic systemic cancer treatment, which interfere with activities of daily living (scoring = 1 on the PRO-CTCAE CIPN interference scale),Onset of CIPN symptoms = 5 years ago.In hematologic cancer: in remission, without active disease.
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study:Diagnosed with metastasized cancer (in case of solid tumors). Likely to start or stop active/maintenance treatment in the upcoming 6 months.Neuropathy symptoms due to other (health-)issues.Inability to complete the multimodal exercise intervention or study procedures or any other contraindications for exercise as determined by their treating physician, including:Severe neurological or cardiac impairment according to the ACSM criteria.Uncontrolled severe respiratory insufficiency or dependence on oxygen suppletion in rest or during exercise. Uncontrolled pain.Cognitive or psychiatric conditions.Insufficient knowledge of the Dutch or English language, whereby the physiotherapist or occupational therapist cannot providethe necessary instructions. Intentions to following an exercise intervention of similar content for neuropathy symptoms.Not capable of making a reasoned assessment of their interest with regard to the research i.e., giving informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Objective:To investigate the effectiveness of a combined modality supervised exercise program on CIPN burden in patients treated with neurotoxic systemic cancer treatment with persistent CIPN. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Objectives: To investigate the effectiveness of a combined modality supervised exercise program on:sensory, motor, and autonomic CIPN symptomspatient specific goalsquality of life and moodfear of falling and fear of movementfatiguedisability, physical function/performance and physical activity.To investigate the cost-effectiveness of a combined modality supervised exercise program compared to wait-list control in terms of costs per quality adjusted life years and costs per unit reduction in neuropathy symptoms.To evaluate patients experiences of the multimodal supervised exercise program.Safety endpoint:Exercise-related (serious) adverse events | — |
Countries
Netherlands
Contacts
Public ContactN.A.A. Huijben
Antoni van Leeuwenhoek (AVL)
Outcome results
None listed