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

March 6, 2026 updated by: Region Jönköping County

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

358

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Sweden
      • Jönköping, Sweden
        • Linköping University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Taxane or Oxaliplatin
Use of compression therapy class 2 (approximately 20-32 mmHg) garments on feet/lower leg and hand/lower arm
Other: Compression therapy
Compression garments class 2
No Intervention: Taxane or oxaliplatin
No intervention as standard therapy

What is the study measuring?

Primary Outcome Measures

Outcome 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.
Time Frame: 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).
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 Outcome Measures

Outcome Measure
Time Frame
Difference in relative dose intensity of taxane respectively oxaliplatin.
Time Frame: From start to finish of neoadjuvant or adjuvant treatment, 1-24 weeks.
From start to finish of neoadjuvant or adjuvant treatment, 1-24 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Region Jönköping County

Collaborators

Linkoeping University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

December 31, 2033

Study Registration Dates

First Submitted

February 17, 2026

First Submitted That Met QC Criteria

March 6, 2026

First Posted (Actual)

March 11, 2026

Study Record Updates

Last Update Posted (Actual)

March 11, 2026

Last Update Submitted That Met QC Criteria

March 6, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-08840-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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