Cryotherapy Gloves for Colon Cancer

Recruiting at 1 trial location

Overseen By Sarah Mendez

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Must be taking: Capecitabine, Oxaliplatin

Disqualifiers: Peripheral neuropathy, Diabetes, Raynaud's, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

Duration: 9 weeks

40 Participants Needed

Trial Summary

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, since the trial involves starting a new chemotherapy regimen, it's best to discuss your current medications with the trial team.

What data supports the effectiveness of the treatment Cryotherapy Gloves for Colon Cancer?

Research shows that oral cryotherapy can help prevent a painful side effect called oral thermal hyperalgesia during oxaliplatin chemotherapy, which is used to treat colorectal cancer. This suggests that cryotherapy might help manage side effects of oxaliplatin, potentially improving the overall treatment experience for patients. ^{1 2 3 4 5}

Is cryotherapy safe for humans?

Cryotherapy, when used during oxaliplatin chemotherapy, has shown a good safety profile with manageable side effects like cold-triggered sensations and temporary nerve issues. These side effects are generally reversible and not severe, making cryotherapy a safe option for many patients. ^{1 2 6 7 8}

What makes cryotherapy gloves unique in treating colon cancer with oxaliplatin?

Cryotherapy gloves are unique because they help prevent cold-triggered side effects, like dysesthesia (abnormal sensation) and oral thermal hyperalgesia (increased sensitivity to temperature), which are common with oxaliplatin treatment. ^{1 2 9 10 11}

What is the purpose of this trial?

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.

Research Team

Sarah Mendez

Principal Investigator

NYU Langone Health

Eligibility Criteria

This trial is for adults over 18 with stage III colon cancer who haven't started chemotherapy yet. They'll be starting a standard chemo treatment called CAPOX. People can't join if they already have nerve damage, diabetes, Raynaud's disease, metabolic syndrome (including high blood pressure and cholesterol), missing upper limbs, or certain autoimmune diseases.

Inclusion Criteria

Willingness to participate in research

I have not received chemotherapy before.

I am starting CAPOX chemotherapy soon.

Exclusion Criteria

I have diabetes.

I have nerve damage in my hands or feet.

I have Raynaud's disease.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive oxaliplatin with or without cryotherapy to prevent peripheral neuropathy

9 weeks

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Cryotherapy
• Oxaliplatin

Trial Overview The study is testing if wearing cryotherapy gloves helps prevent nerve damage in the hands caused by oxaliplatin, a drug used in chemotherapy for colon cancer patients.

Participant Groups

Group I: Cryotherapy Experimental Treatment 1 Intervention

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.

Group II: Control Active Control 1 Intervention

Patients receiving oxaliplatin who are randomized to the Control Arm will not receive the gloves with removable ice packs throughout their treatment.

Oxaliplatin is already approved in European Union, United States, Canada, Japan, Switzerland, China for the following indications:

Approved in European Union as Eloxatin for:

• Colorectal cancer

Approved in United States as Eloxatin for:

• Colorectal cancer

Approved in Canada as Eloxatin for:

• Colorectal cancer

Approved in Japan as Eloxatin for:

• Colorectal cancer

Approved in Switzerland as Eloxatin for:

• Colorectal cancer

Approved in China as Ai Heng for:

• Colorectal cancer

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Findings from Research

Oxaliplatin, when combined with fluorouracil (5-FU), has shown significantly higher response rates (60% or more) in patients with untreated advanced colorectal cancer compared to lower rates when used alone (12% to 24%).

While adding oxaliplatin to 5-FU and leucovorin improves response rates and delays tumor progression, it does not appear to extend overall survival, indicating a need for further research to understand this outcome.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of oxaliplatin in the treatment of colorectal cancer. Rothenberg, ML.[2022]

Oxaliplatin is an effective treatment for colorectal and advanced ovarian cancers, showing a very good safety profile with low hematotoxicity and manageable gastrointestinal side effects, making it suitable for combination therapy.

While oxaliplatin can cause peripheral sensory neuropathy, this side effect is generally reversible and less severe compared to cisplatin, indicating better overall tolerability in patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oxaliplatin in practice. Misset, JL.[2022]

In a study of 80 patients undergoing hyperthermic intraperitoneal chemotherapy (HIPC), those treated with oxaliplatin (OX) experienced significant electrolyte disturbances, including lower sodium levels and higher rates of hyponatremia compared to those treated with mitomycin C (MMC).

Despite these electrolyte issues, the overall complication rates and 30-day mortality were similar between the OX and MMC groups, indicating that while OX may cause predictable disturbances, it does not lead to worse outcomes if monitored and managed properly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Severe electrolyte disturbances after hyperthermic intraperitoneal chemotherapy: oxaliplatin versus mitomycin C. Rueth, NM., Murray, SE., Huddleston, SJ., et al.[2018]

References

1. United States pubmed.ncbi.nlm.nih.gov

Efficacy of Oral Cryotherapy During Oxaliplatin Infusion in Preventing Oral Thermal Hyperalgesia: A Randomized Trial. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Oxaliplatin in colorectal cancer patients living in an arctic or subarctic area: significant cold-triggered dysesthesias and laryngeal reactions. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Efficacy of oxaliplatin in the treatment of colorectal cancer. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Oxaliplatin-resistant colorectal cancer models for nanoparticle hyperthermia. [2021]

5. Japan pubmed.ncbi.nlm.nih.gov

Evaluation of FOLFOX or CAPOX reintroduction with or without bevacizumab in relapsed colorectal cancer patients treated with oxaliplatin as adjuvant chemotherapy (REACT study). [2020]

6. England pubmed.ncbi.nlm.nih.gov

Oxaliplatin in practice. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Safety analysis of FOLFOX4 treatment in colorectal cancer patients: a comparison between two Asian studies and four Western studies. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Minocycline for Symptom Reduction During Oxaliplatin-Based Chemotherapy for Colorectal Cancer: A Phase II Randomized Clinical Trial. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Severe electrolyte disturbances after hyperthermic intraperitoneal chemotherapy: oxaliplatin versus mitomycin C. [2018]

10. France pubmed.ncbi.nlm.nih.gov

Time-shifted co-administration of sub-analgesic doses of ambroxol and pregabalin attenuates oxaliplatin-induced cold allodynia in mice. [2018]

11. Japan pubmed.ncbi.nlm.nih.gov

[Risk Factors for Oxaliplatin-Induced Phlebitis and Venous Pain, and Evaluation of the Preventive Effect of Preheating with a Hot Compress for Administration of Oxaliplatin]. [2018]