Compression Therapy of Hands and Feet for the Prevention of Taxane- or Oxaliplatin-induced Peripheral Neuropathy

Condition(s) studied

Investigational drug(s) / intervention(s)

Compression therapy: Compression garments class 2

Study 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.

Eligibility

Primary outcome measure(s)

• 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).

Trial sites (1)

More Region Jönköping County trials in Sweden