Peripheral Neuropathy Due to ChemotherapyKompXXNCT07464769
Compression Therapy of Hands and Feet for the Prevention of Taxane- or Oxaliplatin-induced Peripheral Neuropathy
A study testing Compression therapy in people with Peripheral Neuropathy Due to Chemotherapy, run by Region Jönköping County at 1 site in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Neuropathy Due to Chemotherapy
- What is being tested?
- Compression therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 358 participants
- Where
- 1 siteSweden
- Study dates
- Apr 2026to 31 Dec 2033
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read more
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.
- Being tested
- Compression therapy
- Keywords
- Breast cancer, Colorectal Cancer, Taxan, Oxaliplatin, Compression therapy, Prevention
- Medical subject headings
- Breast Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compression therapyOther
Compression garments class 2
| Study group | Role | What they receive |
|---|---|---|
| Taxane or Oxaliplatin | Active comparator | Use of compression therapy class 2 (approximately 20-32 mmHg) garments on feet/lower leg and hand/lower arm Receives: Other: Compression therapy |
| Taxane or oxaliplatin | No intervention | No intervention as standard therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 outcomes (1)
Difference in relative dose intensity of taxane respectively oxaliplatin.
Measured: From start to finish of neoadjuvant or adjuvant treatment, 1-24 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2026
- Study startApr 2026 (estimated)
- Primary completionApr 2028 (estimated)
- Study completion31 Dec 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Neuropathy Due to ChemotherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 358 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Jönköping County
- Sponsor type
- Other government
- Collaborators
- Linkoeping University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07464769
- Sponsor's protocol ID
- 2025-08840-01
- Other IDs
- 2025
- Acronym
- KompXX
- Status last verified
- Feb 2026
- First submitted
- 17 Feb 2026
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study of Compression Therapy of Hands and Feet for the Prevention of Taxane- or Oxaliplatin-induced Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT07464769
- Acronym / sponsor ID
- KompXX / 2025-08840-01
- Keywords
- Breast cancer, Colorectal Cancer, Taxan, Oxaliplatin, Compression therapy, Prevention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 358 participants (estimated)
- Lead sponsor
- Region Jönköping CountyOther government
- Collaborators
- Linkoeping University
- Study start
- Apr 2026 (estimated)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- 31 Dec 2033 (estimated)
- First posted
- 11 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Taxane or Oxaliplatin | Active comparator | Other: Compression therapyUse of compression therapy class 2 (approximately 20-32 mmHg) garments on feet/lower leg and hand/lower arm |
| Taxane or oxaliplatin | No intervention | –No intervention as standard therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Compression therapyCompression garments class 2 | Other | Taxane or Oxaliplatin |
Primary outcome
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).
1 secondary outcome
Difference in relative dose intensity of taxane respectively oxaliplatin.
Time frame: From start to finish of neoadjuvant or adjuvant treatment, 1-24 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
Related trials for Peripheral Neuropathy Due to Chemotherapy
Active, not recruiting
The AIUR Trial: Surgical Gloves to Prevent Peripheral Neuropathy
Chemotherapy-induced Peripheral Neuropathy
Not yet recruiting
Continuous Controlled Cooling for Prevention of Chemotherapy-Induced Peripheral Neuropathy
Chemotherapy Induced Peripheral Neuropathy (CIPN)
RecruitingObservational study
Relationship Between Great Toe Strength And Symptoms of Chemotherapy-Induced Peripheral Neuropathy (CIPN)
Chemotherapy-induced Peripheral Neuropathy (CIPN), Healthy
Not yet recruiting
The Effect of Aerobic and Resistance Training With and Without Neurodynamic Exercises on Chemotherapy-induced Peripheral Neuropathy Symptoms and Associated Neuro-immune Mechanisms
Chemotherapy Induced Peripheral Neuropathy (CIPN)
RecruitingEarly Phase 1
Neuroprotective Potential of Cannabidiol (CBD) in Preventing Oxaliplatin (Ox)-Induced Neuropathy
Oxaliplatin Induced Peripheral Neuropathy in Cancer Patients, Metastatic Colorectal Cancer (CRC)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Compression therapy in people with Peripheral Neuropathy Due to Chemotherapy, run by Region Jönköping County at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kristina Engvall, MD PhD (010242100, kompxx.onkologkliniken@rjl.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026; AzTrials last refreshed its copy on 7 Nov 2026.