Colon CancerGLOX-PENNCT07285356
Study to Evaluate the Use of Surgical Gloves for the Prevention of Oxaliplatin-Induced Peripheral Neuropathy
A study testing Surgical Gloves in people with Colon Cancer and Oxaliplatin-induced Peripheral Neuropathy, run by AC Camargo Cancer Center at 1 site in Brazil.
Trial summary
The primary objective of this randomized clinical trial is to assess whether the use of surgical gloves during treatment can prevent the occurrence of oxaliplatin-induced peripheral neuropathy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Cancer, Oxaliplatin-induced Peripheral Neuropathy
- What is being tested?
- Surgical Gloves
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteBrazil
- Study dates
- 6 Oct 2025to 18 Sep 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
- Patients aged 18 years or older who have provided written informed consent.
- Colon adenocarcinoma with high-risk stage III (pT4pN2) or stage IV.
- Oxaliplatin-based treatment in the context of localized or metastatic disease.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
Who cannot join
- Pre-existing neuropathy.
- Uncontrolled diabetes.
- known glove allergies.
- Prior treatment with paclitaxel, docetaxel or oxaliplatin.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
A.C. Camargo Cancer Center
São Paulo, São Paulo
Bruna Kupper, +551121895010 ext. 2832, bruna.catin@accamargo.org.br
About this study
Official title: GLOX-PEN: Phase II Clinical Trial to Evaluate the Use of Surgical Gloves for the Prevention of Oxaliplatin-Induced Peripheral Neuropathy
The primary objective of this randomized clinical trial is to assess whether the use of surgical gloves during treatment can prevent the occurrence of oxaliplatin-induced peripheral neuropathy.
Read the detailed description
Gastrointestinal tumors account for one-quarter of the global cancer incidence and one-third of cancer-related deaths. Chemotherapy-induced peripheral neuropathy (CIPN) is a common adverse effect of oxaliplatin-based treatments. CIPN can lead to an extremely painful and debilitating process, causing significant loss of functional abilities and negatively affecting the quality of life of these patients, as well as activities of daily living (ADLs) such as walking, buttoning clothes, writing, brushing teeth, among others. This condition can even result in a state of vulnerability, with a high risk of falls and other injuries.
Primary Objective and Study Rationale:
Oxaliplatin, widely used to treat patients with colorectal neoplasms, is associated with chemotherapy-induced peripheral neuropathy (CIPN). Given the high prevalence and negative impact of CIPN on quality of life and adherence to cancer treatment, there is a significant gap in identifying effective prevention and management strategies. Although recent evidence suggests that surgical gloves (SG) can mitigate paclitaxel-induced peripheral neuropathy, SGs have not been tested for the prevention of oxaliplatin-induced peripheral neuropathy (OIPN). Therefore, the primary objective of this randomized clinical trial is to evaluate whether the use of SGs during treatment can prevent the occurrence of grade 2 or higher OIPN in the hands, as assessed by CTCAE v5.0 and PRO-CTCAE.
Secondary Objective:
To determine the relationship between Body Mass Index and the presence of sarcopenia, with the occurrence of OIPN; To evaluate the impact of OIPN on patients' health-related quality of life (HRQoL) using the EORTC QLQ-C30 questionnaire; To assess symptoms and functional limitations associated with OIPN using the EORTC QLQ-CIPN20 questionnaire.
- Being tested
- Surgical Gloves
- Keywords
- oxaliplatin-induced peripheral neuropathy, Peripheral Neuropathy, Oxaliplatin, Surgical Gloves, Body Mass Index (BMI), Sarcopenia
- Medical subject headings
- Colonic Neoplasms, Peripheral Nervous System Diseases, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical GlovesDevice
During each chemotherapy cycle, patients in the experimental group will wear compressive surgical gloves (one size smaller than recommended based on palmar surface measurement) on both hands, which will be put on 30 minutes before the infusion and remain in place until 30 minutes after the end of the chemotherapy infusion.
| Study group | Role | What they receive |
|---|---|---|
| Surgical Gloves | Experimental | During each chemotherapy cycle, patients in the experimental arm will wear compressive surgical gloves (0.5 size smaller than recommended based on palmar surface measurement) on both hands, which will be put on 30 minutes before the infusion and remain in place until 30 minutes after the end of the chemotherapy infusion. Receives: Device: Surgical Gloves |
| No Surgical Gloves | No intervention | The control arm will receive treatment according to current recommendations without the use of any devices on the hands. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxaliplatin-Induced Peripheral Neuropathy
The primary objective of this randomized clinical trial is to evaluate whether the use of surgical gloves during treatment can prevent the occurrence of grade 2 or higher oxaliplatin-induced peripheral neuropathy in the hands, as assessed by CTCAE v5.0 .
Measured: Baseline, 2 months, 4 months and 6 months
Secondary outcomes (4)
Sarcopenia assessing by muscle strength, muscle quantity/quality, and physical performance, Body Mass Index (BMI) evaluated by a mathematical formula (kg/m2).
To determine the relationship between BMI and the presence of sarcopenia, with the occurrence of oxaliplatin-induced peripheral neuropathy (OIPN);
Measured: Baseline, 2 months, 4 months and 6 months
Health-related Quality of life questionaries
To evaluate the impact of OIPN on patients' health-related quality of life (HRQoL) using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30). For the Functional Scales, higher scores indicate better functioning (0=poorest ; 100=best). For the Symptom Scales, higher scores indicate greater symptom severity (0=no symptoms; 100=severe). For the Global Health Status/Quality of Life Scale, higher scores reflect a better overall perception of health and quality of life (0=poorest; 100=best).
Measured: Baseline, 2 months, 4 months and 6 months
Functional limitations associated with OIPN
To assess symptoms and functional limitations associated with OIPN using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-CIPN20). All scores are transformed into a standardized 0-100 scale, with higher scores indicating severe symptoms.
Measured: Baseline, 2 months, 4 months and 6 months
Patient reported Peripheral Neuropathy
Patient reported Oxaliplatin-Induced Peripheral Neuropathy assessed by PRO- CTCAE.
Measured: Baseline, 2 months, 4 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start6 Oct 2025
- Primary completion18 Sep 2026 (estimated)
- Study completion18 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Colon CancerStudies 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
- Model description
- This study is a prospective, open-label, randomized, controlled, multicenter clinical trial.
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AC Camargo Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital do Cancer de Londrina
- Responsible party
- Principal investigator, Virgilio Souza e Silva, AC Camargo Cancer Center
- Investigators
- Bruna Catin Kupper, Nurse, PhD, Study chair, AC Camarco Cancer CenterÉverton Germano Melo, Medical Doctor, Principal investigator, Londrina Cancer HospitalVirgilio Souza Silva, Medical Doctor, PhD, Principal investigator, AC Camargo Cancer CenterKarina Oliveira Ribeiro, Nurse, Study chair, AC Camargo Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07285356
- Sponsor's protocol ID
- 90669425.4.1001.5432
- Acronym
- GLOX-PEN
- Status last verified
- Dec 2025
- First submitted
- 17 Nov 2025
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Incidence of grade 2 or higher oxaliplatin-induced peripheral neuropathy (OIPN) in the hands, as assessed by CTCAE v5.0.; Proportion of patients requiring dose adjustments and/or treatment interruptions; Grade 2 or higher OIPN in the patients' feet; Health-related quality of life (HRQoL) using the EORTC QLQ-C30 questionnaire; Assessment of symptoms and associated functional limitations due to OIPN using the EORTC QLQ-CIPN20 questionnaire; Evaluation of the correlation between body mass index (BMI) and the presence of sarcopenia, with the occurrence of OIPN.
Publications
Smith EM. Current methods for the assessment and management of taxane-related neuropathy. Clin J Oncol Nurs. 2013 Feb;17 Suppl:22-34. doi: 10.1188/13.CJON.S1.22-34.
PubMed 23360700Soveri LM, Lamminmaki A, Hanninen UA, Karhunen M, Bono P, Osterlund P. Long-term neuropathy and quality of life in colorectal cancer patients treated with oxaliplatin containing adjuvant chemotherapy. Acta Oncol. 2019 Apr;58(4):398-406. doi: 10.1080/0284186X.2018.1556804. Epub 2019 Jan 14.
PubMed 30638100Tofthagen C. Patient perceptions associated with chemotherapy-induced peripheral neuropathy. Clin J Oncol Nurs. 2010 Jun;14(3):E22-8. doi: 10.1188/10.CJON.E22-E28.
PubMed 20529785Wang S, Zheng R, Li J, Zeng H, Li L, Chen R, Sun K, Han B, Bray F, Wei W, He J. Global, regional, and national lifetime risks of developing and dying from gastrointestinal cancers in 185 countries: a population-based systematic analysis of GLOBOCAN. Lancet Gastroenterol Hepatol. 2024 Mar;9(3):229-237. doi: 10.1016/S2468-1253(23)00366-7. Epub 2024 Jan 4.
PubMed 38185129
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GLOX-PEN: Phase II Clinical Trial to Evaluate the Use of Surgical Gloves for the Prevention of Oxaliplatin-Induced Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT07285356
- Acronym / sponsor ID
- GLOX-PEN / 90669425.4.1001.5432
- Keywords
- oxaliplatin-induced peripheral neuropathy, Peripheral Neuropathy, Oxaliplatin, Surgical Gloves, Body Mass Index (BMI), Sarcopenia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- AC Camargo Cancer CenterUniversity, hospital or other
- Collaborators
- Hospital do Cancer de Londrina
- Study start
- 6 Oct 2025 (actual)
- Primary completion
- 18 Sep 2026 (estimated)
- Study completion
- 18 Sep 2026 (estimated)
- First posted
- 16 Dec 2025 (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.
The primary objective of this randomized clinical trial is to assess whether the use of surgical gloves during treatment can prevent the occurrence of oxaliplatin-induced peripheral neuropathy.
Detailed description
Gastrointestinal tumors account for one-quarter of the global cancer incidence and one-third of cancer-related deaths. Chemotherapy-induced peripheral neuropathy (CIPN) is a common adverse effect of oxaliplatin-based treatments. CIPN can lead to an extremely painful and debilitating process, causing significant loss of functional abilities and negatively affecting the quality of life of these patients, as well as activities of daily living (ADLs) such as walking, buttoning clothes, writing, brushing teeth, among others. This condition can even result in a state of vulnerability, with a high risk of falls and other injuries.
Primary Objective and Study Rationale:
Oxaliplatin, widely used to treat patients with colorectal neoplasms, is associated with chemotherapy-induced peripheral neuropathy (CIPN). Given the high prevalence and negative impact of CIPN on quality of life and adherence to cancer treatment, there is a significant gap in identifying effective prevention and management strategies. Although recent evidence suggests that surgical gloves (SG) can mitigate paclitaxel-induced peripheral neuropathy, SGs have not been tested for the prevention of oxaliplatin-induced peripheral neuropathy (OIPN). Therefore, the primary objective of this randomized clinical trial is to evaluate whether the use of SGs during treatment can prevent the occurrence of grade 2 or higher OIPN in the hands, as assessed by CTCAE v5.0 and PRO-CTCAE.
Secondary Objective:
To determine the relationship between Body Mass Index and the presence of sarcopenia, with the occurrence of OIPN; To evaluate the impact of OIPN on patients' health-related quality of life (HRQoL) using the EORTC QLQ-C30 questionnaire; To assess symptoms and functional limitations associated with OIPN using the EORTC QLQ-CIPN20 questionnaire.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study is a prospective, open-label, randomized, controlled, multicenter clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Surgical Gloves | Experimental | Device: Surgical GlovesDuring each chemotherapy cycle, patients in the experimental arm will wear compressive surgical gloves (0.5 size smaller than recommended based on palmar surface measurement) on both hands, which will be put on 30 minutes before the infusion and remain in place until 30 minutes after the end of the chemotherapy infusion. |
| No Surgical Gloves | No intervention | –The control arm will receive treatment according to current recommendations without the use of any devices on the hands. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged 18 years or older who have provided written informed consent.
- Colon adenocarcinoma with high-risk stage III (pT4pN2) or stage IV.
- Oxaliplatin-based treatment in the context of localized or metastatic disease.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
Key exclusion criteria (4 listed)
- Pre-existing neuropathy.
- Uncontrolled diabetes.
- known glove allergies.
- Prior treatment with paclitaxel, docetaxel or oxaliplatin.
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 |
|---|---|---|
| Surgical GlovesDuring each chemotherapy cycle, patients in the experimental group will wear compressive surgical gloves (one size smaller than recommended based on palmar surface measurement) on both hands, which will be put on 30 minutes before the infusion and remain in place until 30 minutes after the end of the chemotherapy infusion. | Device | Surgical Gloves |
Primary outcome
Oxaliplatin-Induced Peripheral Neuropathy
Time frame: Baseline, 2 months, 4 months and 6 months
The primary objective of this randomized clinical trial is to evaluate whether the use of surgical gloves during treatment can prevent the occurrence of grade 2 or higher oxaliplatin-induced peripheral neuropathy in the hands, as assessed by CTCAE v5.0 .
4 secondary outcomes
Sarcopenia assessing by muscle strength, muscle quantity/quality, and physical performance, Body Mass Index (BMI) evaluated by a mathematical formula (kg/m2).
Time frame: Baseline, 2 months, 4 months and 6 months
Health-related Quality of life questionaries
Time frame: Baseline, 2 months, 4 months and 6 months
Functional limitations associated with OIPN
Time frame: Baseline, 2 months, 4 months and 6 months
Patient reported Peripheral Neuropathy
Time frame: Baseline, 2 months, 4 months and 6 months
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 Dec 2025.
- Background: PubMed 23360700Smith EM. Current methods for the assessment and management of taxane-related neuropathy. Clin J Oncol Nurs. 2013 Feb;17 Suppl:22-34. doi: 10.1188/13.CJON.S1.22-34.
- Background: PubMed 30638100Soveri LM, Lamminmaki A, Hanninen UA, Karhunen M, Bono P, Osterlund P. Long-term neuropathy and quality of life in colorectal cancer patients treated with oxaliplatin containing adjuvant chemotherapy. Acta Oncol. 2019 Apr;58(4):398-406. doi: 10.1080/0284186X.2018.1556804. Epub 2019 Jan 14.
- Background: PubMed 20529785Tofthagen C. Patient perceptions associated with chemotherapy-induced peripheral neuropathy. Clin J Oncol Nurs. 2010 Jun;14(3):E22-8. doi: 10.1188/10.CJON.E22-E28.
- Background: PubMed 38185129Wang S, Zheng R, Li J, Zeng H, Li L, Chen R, Sun K, Han B, Bray F, Wei W, He J. Global, regional, and national lifetime risks of developing and dying from gastrointestinal cancers in 185 countries: a population-based systematic analysis of GLOBOCAN. Lancet Gastroenterol Hepatol. 2024 Mar;9(3):229-237. doi: 10.1016/S2468-1253(23)00366-7. Epub 2024 Jan 4.
- Individual participant dataSharing planned: Yes. Incidence of grade 2 or higher oxaliplatin-induced peripheral neuropathy (OIPN) in the hands, as assessed by CTCAE v5.0.; Proportion of patients requiring dose adjustments and/or treatment interruptions; Grade 2 or higher OIPN in the patients' feet; Health-related quality of life (HRQoL) using the EORTC QLQ-C30 questionnaire; Assessment of symptoms and associated functional limitations due to OIPN using the EORTC QLQ-CIPN20 questionnaire; Evaluation of the correlation between body mass index (BMI) and the presence of sarcopenia, with the occurrence of OIPN.
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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.
Bruna Catin Kupper, Nurse, PhD study chair
AC Camarco Cancer Center
Éverton Germano Melo, Medical Doctor principal investigator
Londrina Cancer Hospital
Virgilio Souza Silva, Medical Doctor, PhD principal investigator
AC Camargo Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical Gloves in people with Colon Cancer and Oxaliplatin-induced Peripheral Neuropathy, run by AC Camargo Cancer Center at 1 site in Brazil.
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 Dec 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 Brazil. 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 Virgilio Souza Silva, Medical Doctor, PhD (+55 (11) 2189-5000, virss2013@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxaliplatin-Induced Peripheral Neuropathy (time frame: Baseline, 2 months, 4 months and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07285356, which also lists 4 linked publications.
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 Dec 2025.