Colon CancerNCT06281925
Cryotherapy & Oxaliplatin
A study testing Cryotherapy Gloves in people with Colon Cancer and Peripheral Neuropathy, run by NYU Langone Health at 2 sites in United States.
Trial summary
The primary objective of this study is to determine if cryotherapy is beneficial to patients with colon cancer who are receiving oxaliplatin in the prevention of developing chemotherapy induced peripheral neuropathy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Cancer, Peripheral Neuropathy
- What is being tested?
- Cryotherapy Gloves
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 Mar 2025to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Over the age of 18 years
- Willingness to participate in research
- Diagnosed with stage III colon cancer
- Chemotherapy naïve
- Planning to initiate Capecitabine + Oxaliplatin (CAPOX) chemotherapy regimen as part of standard of care.
Who cannot join
- Pre-existing peripheral neuropathy
- Pre-existing diabetes
- Raynaud's disease
- Metabolic syndrome, including: Hypertension; Hypercholesterolemia; and Obesity (BSA > 2)
- Upper extremity amputees
- Specific autoimmune diseases: Guillain-Barre; Lupus; Rheumatoid arthritis; and Sjogren's syndrome
Trial locations and contacts
2 sites in 1 country.
United States2 sites
NYU Langone Health
Mineola, New York, 11501
NYU Langone Health
New York, New York, 10016
About this study
Official title: A Phase II Randomized Interventional Pilot Study for Colon Cancer Patients Receiving Oxaliplatin: Benefits of Cryotherapy in Prevention of Peripheral Neuropathy
The primary objective of this study is to determine if cryotherapy is beneficial to patients with colon cancer who are receiving oxaliplatin in the prevention of developing chemotherapy induced peripheral neuropathy.
Read the detailed description
Peripheral neuropathy often manifests as numbness and tingling in the hands and feet, which may be detrimental to the patients' overall safety and quality of life, thereby causing them to stop or delay treatment. Everyday tasks such as walking, buttoning a shirt, or tying shoes can become challenging. Select chemotherapy agents are known to cause significant peripheral neuropathy. Studies have been performed demonstrating efficacy of using cryotherapy, which causes vasoconstriction, to targeted areas of the body, in relation to paclitaxel. These studies have shown drastic differences between those who receive cryotherapy during treatment and those who do not. There are few studies on the use of cryotherapy in the prevention of peripheral neuropathy with the use of oxaliplatin, which will be undertaken in this study.
- Conditions
- Colon Cancer, Peripheral Neuropathy
- Being tested
- Cryotherapy Gloves
- Medical subject headings
- Colonic Neoplasms, Peripheral Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cryotherapy GlovesDevice
All patients in the intervention group will receive cryotherapy with cold packs enclosed in a fabric envelope (gloves). The fabric envelope (gloves) will be patient specific.
| Study group | Role | What they receive |
|---|---|---|
| Cryotherapy | Experimental | Patients receiving oxaliplatin who are randomized to the Interventional (Cryotherapy) Arm will wear a pair of gloves that has removable ice packs throughout their treatment, starting 15 minutes before and ending 15 minutes after completion of oxaliplatin. These ice packs will be replaced every 30 minutes. The total wearing time of the cryotherapy will be approximately 2 hours. Receives: Device: Cryotherapy Gloves |
| Control | No intervention | Patients receiving oxaliplatin who are randomized to the Control Arm will not receive the gloves with removable ice packs throughout their treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants with Peripheral Neuropathy at Visit 2
Presence of peripheral neuropathy will be evaluated using common terminology criteria for adverse events (CTCAE) version 5.
Measured: Visit 2 (Day 1)
Proportion of Participants with Peripheral Neuropathy at Visit 3
Presence of peripheral neuropathy will be evaluated using common terminology criteria for adverse events (CTCAE) version 5.
Measured: Visit 3 (Day 21)
Proportion of Participants with Peripheral Neuropathy at Visit 4
Presence of peripheral neuropathy will be evaluated using common terminology criteria for adverse events (CTCAE) version 5.
Measured: Visit 4 (Day 42)
Proportion of Participants with Peripheral Neuropathy at Visit 5
Presence of peripheral neuropathy will be evaluated using common terminology criteria for adverse events (CTCAE) version 5.
Measured: Visit 5 (Day 63)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start13 Mar 2025
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Why it stopped: Study paused to enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sarah Mendez, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06281925
- Sponsor's protocol ID
- 22-01363
- Status last verified
- Mar 2026
- First submitted
- 21 Feb 2024
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: sarah.mendez@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomized Interventional Pilot Study for Colon Cancer Patients Receiving Oxaliplatin: Benefits of Cryotherapy in Prevention of Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT06281925
- Acronym / sponsor ID
- 22-01363
- Conditions
- Colon Cancer, Peripheral Neuropathy
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Study paused to enrollment
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 13 Mar 2025 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 28 Feb 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.
The primary objective of this study is to determine if cryotherapy is beneficial to patients with colon cancer who are receiving oxaliplatin in the prevention of developing chemotherapy induced peripheral neuropathy.
Detailed description
Peripheral neuropathy often manifests as numbness and tingling in the hands and feet, which may be detrimental to the patients' overall safety and quality of life, thereby causing them to stop or delay treatment. Everyday tasks such as walking, buttoning a shirt, or tying shoes can become challenging. Select chemotherapy agents are known to cause significant peripheral neuropathy. Studies have been performed demonstrating efficacy of using cryotherapy, which causes vasoconstriction, to targeted areas of the body, in relation to paclitaxel. These studies have shown drastic differences between those who receive cryotherapy during treatment and those who do not. There are few studies on the use of cryotherapy in the prevention of peripheral neuropathy with the use of oxaliplatin, which will be undertaken in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cryotherapy | Experimental | Device: Cryotherapy GlovesPatients receiving oxaliplatin who are randomized to the Interventional (Cryotherapy) Arm will wear a pair of gloves that has removable ice packs throughout their treatment, starting 15 minutes before and ending 15 minutes after completion of oxaliplatin. These ice packs will be replaced every 30 minutes. The total wearing time of the cryotherapy will be approximately 2 hours. |
| Control | No intervention | –Patients receiving oxaliplatin who are randomized to the Control Arm will not receive the gloves with removable ice packs throughout their treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Over the age of 18 years
- Willingness to participate in research
- Diagnosed with stage III colon cancer
- Chemotherapy naïve
- Planning to initiate Capecitabine + Oxaliplatin (CAPOX) chemotherapy regimen as part of standard of care.
Key exclusion criteria (6 listed)
- Pre-existing peripheral neuropathy
- Pre-existing diabetes
- Raynaud's disease
- Metabolic syndrome, including: Hypertension; Hypercholesterolemia; and Obesity (BSA > 2)
- Upper extremity amputees
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 |
|---|---|---|
| Cryotherapy GlovesAll patients in the intervention group will receive cryotherapy with cold packs enclosed in a fabric envelope (gloves). The fabric envelope (gloves) will be patient specific. | Device | Cryotherapy |
Primary outcome
Proportion of Participants with Peripheral Neuropathy at Visit 2
Time frame: Visit 2 (Day 1)
Presence of peripheral neuropathy will be evaluated using common terminology criteria for adverse events (CTCAE) version 5.
Proportion of Participants with Peripheral Neuropathy at Visit 3
Time frame: Visit 3 (Day 21)
Presence of peripheral neuropathy will be evaluated using common terminology criteria for adverse events (CTCAE) version 5.
Proportion of Participants with Peripheral Neuropathy at Visit 4
Time frame: Visit 4 (Day 42)
Presence of peripheral neuropathy will be evaluated using common terminology criteria for adverse events (CTCAE) version 5.
Proportion of Participants with Peripheral Neuropathy at Visit 5
Time frame: Visit 5 (Day 63)
Presence of peripheral neuropathy will be evaluated using common terminology criteria for adverse events (CTCAE) version 5.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Individual participant dataSharing planned: Yes. The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: sarah.mendez@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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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. This study is not recruiting at the moment.
Sarah Mendez principal investigator
NYU Langone Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryotherapy Gloves in people with Colon Cancer and Peripheral Neuropathy, run by NYU Langone Health at 2 sites in United States.
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 6 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: paused, as of the sponsor's last update on 6 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 2 sites in United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants with Peripheral Neuropathy at Visit 2 (time frame: Visit 2 (Day 1)). The study lists 4 primary outcomes in all. 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 6 Mar 2026.