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

NCT07464769 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 358

Last updated 2026-03-11

No results posted yet for this 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.

Conditions

  • Peripheral Neuropathy Due to Chemotherapy

Interventions

OTHER

Compression therapy

Compression garments class 2

Sponsors & Collaborators

  • Linkoeping University

    collaborator OTHER_GOV

  • Region Jönköping County

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2028-04-30
Completion
2033-12-31

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07464769 on ClinicalTrials.gov