Taxane-induced Peripheral NeuropathyComPrendoNCT06464536
Evaluation of the Efficacy of Compression With Tight Surgical Gloves in Patients With Taxane-based Therapy
A study testing Compression in people with Taxane-induced Peripheral Neuropathy, run by St.Gallen University of Applied Sciences at 1 site in Switzerland.
Trial summary
In this study, the effect of compression therapy of the hands with tight surgical gloves to reduce peripheral neuropathy in adult patients during the application of taxanes will be evaluated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Taxane-induced Peripheral Neuropathy
- What is being tested?
- Compression
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 114 participants
- Where
- 1 siteSwitzerland
- Study dates
- 3 Feb 2025to Mar 2026
- 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
- Mamma or Urogenital carcinoma
- first treatment with Taxanes (nab-Paclitaxel, Paclitaxel, Docetaxel)
- signed informed consent
- sufficient proficiency in German or English
Who cannot join
- other therapy that could have caused peripheral neuropathy within the last 24 months (Taxane, Platin, Vincaalkaloids, etc.)
- History of neuropathy such as Raynaud's phenomenon, fibromyalgia and diabetic polyneuropathy
- Use of polyneuropathy medications including duloxetine; gabapentin/pregabalin; topical amitriptyline, ketamine, baclofen; oral cannabinoids; tricyclic antidepressants; and ganglioside monosialic acid
- such impaired cognition that prevents participation in the study according to the assessment of the caregivers
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Zuerich
Zurich, 8091
About this study
Official title: Tight Surgical Gloves to Prevent Chemotherapy-induced Peripheral Neuropathy: A Randomized Controlled Trial to Evaluate the Efficacy of Compression Therapy in Patients With Taxane-based Chemotherapy for Breast and Urogenital Cancer
In this study, the effect of compression therapy of the hands with tight surgical gloves to reduce peripheral neuropathy in adult patients during the application of taxanes will be evaluated.
Read the detailed description
Chemotherapy-induced peripheral neuropathy (CIPN) is a common side effect of treatment with taxanes. The damage to peripheral nerves leads to pain, numbness, and motor dysfunction, which is very distressing for patients and often results in the reduction of the therapeutic dose of taxanes. Preventive measures are limited, but recent studies show that compression of the hands with tight surgical gloves can significantly reduce the incidence of CIPN. The aim of this randomized controlled trial is to investigate the efficacy of compression therapy in reducing CIPN during taxane-based chemotherapy. The randomized controlled and double-blind study will be conducted at the Comprehensive Cancer Center Zurich (CCCZ) of the University Hospital Zurich from 07/24 to 06/25. Participants will be recruited if they have breast cancer or a urogenital carcinoma and are receiving nab-paclitaxel, paclitaxel, or docetaxel. Exclusion criteria include previous neurotoxic treatment, existing neuropathy, peripheral vascular disease, or the use of medications that affect polyneuropathy. The intervention group will wear surgical gloves with a compression pressure of 23-32 mmHg (equivalent to compression class II) for 30 minutes before, during, and 30 minutes after the infusion. The control group will wear non-compressing gloves with a pressure of less than 3 mmHg. The primary endpoint is the occurrence of moderate to severe CIPN within four therapy cycles, measured according to NCI-CTCAE criteria. Secondary endpoints include patient-reported symptoms and quality of life, assessed by the FACT/COG-NTX questionnaire. Comfort and adherence to the compression therapy will also be evaluated. Participants will be randomized into two groups of 57 each. Data collection and analysis will be conducted according to standardized procedures, and the data will be securely and confidentially stored and managed.
- Conditions
- Taxane-induced Peripheral Neuropathy
- Being tested
- Compression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CompressionOther
Also called Compression with surgical gloves
conventional surgical gloves that are commonly used in hospitals will be used for compression therapy of both hands
| Study group | Role | What they receive |
|---|---|---|
| Compression group | Experimental | Participants in the intervention group wear surgical gloves at each taxane administration. The intervention will start 30 minutes before the infusion, continue during the infusion, and last until 30 minutes after the infusion ends. Glove size will be measured on both hands before the first use, following the European standard for medical gloves. The gloves will be worn half a size (0.5) smaller than the appropriate size on both hands. With the help of talcum powder, a second glove of the same size will be worn over the first glove on both hands. After selecting the glove size, the compression strength of the two overlapping gloves will be measured once using a pressure measuring device (PicoPress (c)). The PicoPress(c) device (Microlab Elettronica, Italy) is already in use to measure the pressure of compression bandages. The target range for compression pressure is between 23-32 mmHg (compression class 2) (RAL Deutsches Institut für Gütesicherung und Kennzeichnung e. V., 2008). Receives: Other: Compression |
| Control group | Sham comparator | Participants in the control group will wear two non-compressing surgical gloves of their appropriate size on both hands during each administration of taxanes. The intervention will begin 30 minutes before the infusion, continue during the infusion, and last until 30 minutes after the infusion ends. After selecting the glove size, the compression strength of the two overlapping gloves will be measured once using a pressure measuring device (PicoPress(c)) to verify the pressure. The target range is below 3 mmHg. Measurements with the pressure sensor will be repeated as needed with gloves half a size larger to ensure a low pressure level of less than 3 mmHg. Receives: Other: Compression |
What is being measured
The primary outcome is the main question the study is designed to answer.
peripheral polyneuropathy
measured with the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grades 0-4 : 0=none, 1=Asymptomatic; clinical or diagnostic observations only, 2=Moderate symptoms; limiting instrumental ADL; 3=Severe symptoms; limiting self care ADL; 4=Life-threatening consequences; urgent intervention indicated (i.e., higher scores meaning worse symptoms)
Measured: at the beginning (first day) of each of the first four cycles of chemotherapy for each participant (Cycles range from 7 to 28 days)
Secondary outcomes (4)
peripheral polyneuropathy patient reported outcome
measured with the neuropathy Subscale of the Functional Assessment of Cancer Therapy - Gynecologic Oncology Group - Neurotoxicity (FACT/COG-NTX), The FACT-NTX subscale comprises 11 5-point ordinal scaled items (0=not at all to 4=very much). The points for each item are totaled and can range from 0=no symptoms to 44=severe symptoms. The participant is counted as a case if the change in the FACT-NTX reaches ≥5 points.
Measured: at the beginning (first day) of each of the first four cycles of chemotherapy for each participant (Cycles range from 7 to 28 days)
comfort of compression therapy
comfort will be measured with a 0 to 3 scale (0=not comfortable at all, 3=very comfortable)
Measured: at the beginning (first day) of each of the first four cycles of chemotherapy for each participant (Cycles range from 7 to 28 days)
adherence with compression therapy
percentage of time that compression should have been administered
Measured: at the beginning (first day) of each of the first four cycles of chemotherapy for each participant (Cycles range from 7 to 28 days)
Frequency of the application of manual abilities (like sewing, knitting, painting, playing the piano or similar)
Ordinal 1-item scale, ranging from from 0=never to 4=daily
Measured: at the beginning (first day) of each of the first four cycles of chemotherapy for each participant (Cycles range from 7 to 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2024
- Study start3 Feb 2025
- Primary completionSep 2025 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Taxane-induced Peripheral NeuropathyStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St.Gallen University of Applied Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- University of Zurich
- Responsible party
- Sponsor
- Investigators
- Anna Götz, PhD, Principal investigator, USZAntje Koller, PhD, Principal investigator, St.Gallen University of Applied Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06464536
- Sponsor's protocol ID
- St.GallenU
- Acronym
- ComPrendo
- Status last verified
- May 2025
- First submitted
- 5 Jun 2024
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: secondary data analysis are planned to be possible on request, data that may disclose the patients identity will be deleted from the dataset
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tight Surgical Gloves to Prevent Chemotherapy-induced Peripheral Neuropathy: A Randomized Controlled Trial to Evaluate the Efficacy of Compression Therapy in Patients With Taxane-based Chemotherapy for Breast and Urogenital Cancer
- ClinicalTrials.gov ID
- NCT06464536
- Acronym / sponsor ID
- ComPrendo / St.GallenU
- Conditions
- Taxane-induced Peripheral Neuropathy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- St.Gallen University of Applied SciencesUniversity, hospital or other
- Collaborators
- University of Zurich
- Study start
- 3 Feb 2025 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 18 Jun 2024 (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.
In this study, the effect of compression therapy of the hands with tight surgical gloves to reduce peripheral neuropathy in adult patients during the application of taxanes will be evaluated.
Detailed description
Chemotherapy-induced peripheral neuropathy (CIPN) is a common side effect of treatment with taxanes. The damage to peripheral nerves leads to pain, numbness, and motor dysfunction, which is very distressing for patients and often results in the reduction of the therapeutic dose of taxanes. Preventive measures are limited, but recent studies show that compression of the hands with tight surgical gloves can significantly reduce the incidence of CIPN. The aim of this randomized controlled trial is to investigate the efficacy of compression therapy in reducing CIPN during taxane-based chemotherapy. The randomized controlled and double-blind study will be conducted at the Comprehensive Cancer Center Zurich (CCCZ) of the University Hospital Zurich from 07/24 to 06/25. Participants will be recruited if they have breast cancer or a urogenital carcinoma and are receiving nab-paclitaxel, paclitaxel, or docetaxel. Exclusion criteria include previous neurotoxic treatment, existing neuropathy, peripheral vascular disease, or the use of medications that affect polyneuropathy. The intervention group will wear surgical gloves with a compression pressure of 23-32 mmHg (equivalent to compression class II) for 30 minutes before, during, and 30 minutes after the infusion. The control group will wear non-compressing gloves with a pressure of less than 3 mmHg. The primary endpoint is the occurrence of moderate to severe CIPN within four therapy cycles, measured according to NCI-CTCAE criteria. Secondary endpoints include patient-reported symptoms and quality of life, assessed by the FACT/COG-NTX questionnaire. Comfort and adherence to the compression therapy will also be evaluated. Participants will be randomized into two groups of 57 each. Data collection and analysis will be conducted according to standardized procedures, and the data will be securely and confidentially stored and managed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Compression group | Experimental | Other: CompressionParticipants in the intervention group wear surgical gloves at each taxane administration. The intervention will start 30 minutes before the infusion, continue during the infusion, and last until 30 minutes after the infusion ends. Glove size will be measured on both hands before the first use, following the European standard for medical gloves. The gloves will be worn half a size (0.5) smaller than the appropriate size on both hands. With the help of talcum powder, a second glove of the same size will be worn over the first glove on both hands. After selecting the glove size, the compression strength of the two overlapping gloves will be measured once using a pressure measuring device (PicoPress (c)). The PicoPress(c) device (Microlab Elettronica, Italy) is already in use to measure the pressure of compression bandages. The target range for compression pressure is between 23-32 mmHg (compression class 2) (RAL Deutsches Institut für Gütesicherung und Kennzeichnung e. V., 2008). |
| Control group | Sham comparator | Other: CompressionParticipants in the control group will wear two non-compressing surgical gloves of their appropriate size on both hands during each administration of taxanes. The intervention will begin 30 minutes before the infusion, continue during the infusion, and last until 30 minutes after the infusion ends. After selecting the glove size, the compression strength of the two overlapping gloves will be measured once using a pressure measuring device (PicoPress(c)) to verify the pressure. The target range is below 3 mmHg. Measurements with the pressure sensor will be repeated as needed with gloves half a size larger to ensure a low pressure level of less than 3 mmHg. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Mamma or Urogenital carcinoma
- first treatment with Taxanes (nab-Paclitaxel, Paclitaxel, Docetaxel)
- signed informed consent
- sufficient proficiency in German or English
Key exclusion criteria (4 listed)
- other therapy that could have caused peripheral neuropathy within the last 24 months (Taxane, Platin, Vincaalkaloids, etc.)
- History of neuropathy such as Raynaud's phenomenon, fibromyalgia and diabetic polyneuropathy
- Use of polyneuropathy medications including duloxetine; gabapentin/pregabalin; topical amitriptyline, ketamine, baclofen; oral cannabinoids; tricyclic antidepressants; and ganglioside monosialic acid
- such impaired cognition that prevents participation in the study according to the assessment of the caregivers
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 |
|---|---|---|
| CompressionAlso: Compression with surgical glovesconventional surgical gloves that are commonly used in hospitals will be used for compression therapy of both hands | Other | Compression group, Control group |
Primary outcome
peripheral polyneuropathy
Time frame: at the beginning (first day) of each of the first four cycles of chemotherapy for each participant (Cycles range from 7 to 28 days)
measured with the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grades 0-4 : 0=none, 1=Asymptomatic; clinical or diagnostic observations only, 2=Moderate symptoms; limiting instrumental ADL; 3=Severe symptoms; limiting self care ADL; 4=Life-threatening consequences; urgent intervention indicated (i.e., higher scores meaning worse symptoms)
4 secondary outcomes
peripheral polyneuropathy patient reported outcome
Time frame: at the beginning (first day) of each of the first four cycles of chemotherapy for each participant (Cycles range from 7 to 28 days)
comfort of compression therapy
Time frame: at the beginning (first day) of each of the first four cycles of chemotherapy for each participant (Cycles range from 7 to 28 days)
adherence with compression therapy
Time frame: at the beginning (first day) of each of the first four cycles of chemotherapy for each participant (Cycles range from 7 to 28 days)
Frequency of the application of manual abilities (like sewing, knitting, painting, playing the piano or similar)
Time frame: at the beginning (first day) of each of the first four cycles of chemotherapy for each participant (Cycles range from 7 to 28 days)
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 16 May 2025.
- Individual participant dataSharing planned: Undecided. secondary data analysis are planned to be possible on request, data that may disclose the patients identity will be deleted from the dataset
Related trials for Taxane-induced Peripheral Neuropathy
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AYUrvedic Foot Massage for Symtoms of Taxane-induced Peripheral nEuroPathy
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Docetaxel or Paclitaxel in Reducing Chemotherapy-Induced Peripheral Neuropathy in African American Patients With Stage I-III Breast Cancer
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Treatment Effects on Development of Chemotherapy-Induced Peripheral Neuropathy in Patients With Cancer
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Efficacy and Safety of Duloxetine in Chinese Solid Tumor Patients With Taxanes-induced Painful Peripheral Neuropathy
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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.
Anna Götz, PhD principal investigator
USZ
Antje Koller, PhD principal investigator
St.Gallen University of Applied Sciences
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 in people with Taxane-induced Peripheral Neuropathy, run by St.Gallen University of Applied Sciences at 1 site in Switzerland.
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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 16 May 2025. 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 Switzerland. 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. Some participants in this study may receive a placebo. 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 Anna Götz, PhD (+41 43 253 ext. 2218, anna.goetz@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
peripheral polyneuropathy (time frame: at the beginning (first day) of each of the first four cycles of chemotherapy for each participant (Cycles range from 7 to 28 days)). 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 16 May 2025.