Peripheral Neuropathy Due to Chemotherapy
Conditions
Keywords
Breast cancer, Colorectal Cancer, Taxan, Oxaliplatin, Compression therapy, Prevention
Brief summary
Population Cohort 1 Taxane: Breast cancer patients; (neo-)adjuvant treatment Cohort 2 Oxaliplatin: Colorectal cancer patients; (neo-)adjuvant treatment Study design Multicentre, unblinded randomised controlled study Study rationale Chemotherapy-induced peripheral neuropathy is a dose-limiting side effect during treatment and cause persistent impairment and worsening of quality of life in cancer survivors. Compression therapy could be a plausible preventive intervention, although practice changing studies are lacking. Aims To investigate if compression therapy of the hands and feet can reduce the prevalence of both acute and persistent CIPN symptoms caused by taxanes or oxaliplatin. Furthermore, to investigate if compression therapy impact the level of taxane or oxaliplatin dose reductions. Endpoints Primary endpoint * The difference in the occurrence of sensory chemotherapy-induced peripheral neuropathy (CIPN) Selected secondary endpoints * Key secondary endpoint: Difference in relative dose intensity of taxane respectively oxaliplatin. * The difference in the occurrence of motor and autonomic chemotherapy-induced peripheral neuropathy (CIPN). * Difference in occurrence of persistent patient-reported CIPN symptoms 1, 3 and 5 years after start of neurotoxic chemotherapy (EORTC CIPN20) * Health-related quality of life at baseline and after 1, 3, 5 years (EORTC QLQ C30) Exploratory endpoints * Prevalence of autonomic neurotoxicity after neurotoxic treatment, defined as increase of prevalence from baseline to one year after treatment. Substudy • Development of pharmacogenetic risk prediction models of acute respectively persistent taxane induced peripheral neuropathy. Sample size Randomisation 1:1, per site Taxane cohort 268 breast cancer patients, stratification on taxane type Oxaliplatin cohort 90 colorectal cancer patients, stratification on length of treatment Follow-up Patient-reported CIPN symptoms during treatment and at time point up to 5 years post-treatment.
Interventions
OTHERCompression therapy
Compression garments class 2
Sponsors
Region Jönköping County
Linkoeping University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
o Scheduled neurotoxic treatment in any of the following settings: Taxane cohort * Breast cancer patients planned for either neoadjuvant or adjuvant taxane treatment Oxaliplatin cohort * Rectal cancer patients planned for total neoadjuvant treatment including oxaliplatin * Colorectal cancer patients planned for adjuvant chemotherapy including oxaliplatin, without prior neoadjuvant oxaliplatin treatment * Understand written and oral Swedish.
Exclusion criteria
* Previous neurotoxic chemotherapy\* treatment * Distant metastases * Any psychiatric disorder or health disorder that causes an inability to make an informed consent to participate. * Any manifest clinically significant peripheral neuropathy according to treating physician. * Current lymphoedema in limbs requiring compression therapy. * Ongoing pregnancy. * Planned taxane or oxaliplatin treatment shorter than 8 weeks or longer than 26 weeks * Planned compression or cryotherapy of hands and/or feet during taxane or oxaliplatin * Taxanes (docetaxel, paclitaxel, nabpaclitaxel), platinum components (carboplatin, oxaplatin, cisplatin), vinca-alkaloids (vincristine, vinblastine, vinorelbine, eribulin), bortezomid, thalidomide, antibody drug conjugate including vedotin or emtansine.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The difference in the occurrence of sensory chemotherapy-induced peripheral neuropathy (CIPN), defined as the absolute increase from the patient's baseline score in the EORTC CIPN20 sensory PN subscale. | This is determined by using the patient's highest reported score from treatment start and up to 6-10 weeks after the final dose (1-24 weeks of treatment). |
Secondary
| Measure | Time frame |
|---|---|
| Difference in relative dose intensity of taxane respectively oxaliplatin. | From start to finish of neoadjuvant or adjuvant treatment, 1-24 weeks. |
Countries
Sweden
Contacts
CONTACTKristina Engvall, MD PhD
Outcome results
None listed