PREventing CHemotherapy Induced Neuropathy (PreChIN)

Study Overview
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Brief Summary
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The project is designed to study the use of localized hypothermia alone, or with compression to the limbs during chemotherapy infusion for the prevention of chemotherapy induced peripheral neuropathy (CIPN). As a pilot study, safety, tolerability and early clinical activity will be studied. The study will be conducted on healthy volunteers and cancer patients receiving taxane chemotherapy.

Detailed Description
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Localized limb hypothermia during chemotherapeutic infusion may prevent a common side effect of chemotherapy: chemotherapy-induced peripheral neuropathy (CIPN). There are no reliable methods for the prevention or the treatment of CIPN. On the basis of the dose-related pathophysiology of CIPN, the investigators hypothesize that reducing the delivery of the toxic chemotherapeutic agents to the peripheral nerves by reducing blood flow through hypothermia may reduce the occurrence of CIPN. The proposed potential treatment method would aim to reduce the development of CIPN. This project comprises of a healthy subject trial to investigate the best tolerated temperature which will be used in cancer subject trial to investigate the safety and tolerability of hypothermia or cryocompression (hypothermia with pressure) in the prevention of CIPN in cancer subjects undergoing taxane-based chemotherapy.

Official Title
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PREventing CHemotherapy Induced Neuropathy (PreChIN)

Conditions
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Chemotherapy-induced Peripheral Neuropathy (CIPN)

Intervention / Treatment
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* Device: Hypothermia
* Device: Cryocompression


Participation Criteria
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Eligibility Criteria
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The inclusion criterion for the healthy subjects Age 21-80 years Signed informed consent from patient No history of neuropathy ECOG 0 No history of hospitalization in the past 6 months The inclusion criteria for the cancer patients undergoing taxane-based chemotherapy Age 21- 80 years. Signed informed consent from patient or legal representative. Scheduled to receive taxane-based chemotherapy The exclusion criteria for both healthy subjects and cancer patients Open skin wound or ulcers of the limbs A score of more than 5 in the Total Neuropathy Score (TNS) at baseline (Not applicable for healthy subjects) History of Raynaud's phenomenon, peripheral vascular disease, or poorly controlled diabetes

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: The first part of this study is in healthy subjects, followed by breast cancer patients receiving paclitaxel to study the effect of limb hypothermia in the prevention of chemotherapy-induced neuropathy. The second part of this study is to study the effect of cryocompression in the prevention of chemotherapy-induced neuropathy.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healthy subjects (Hypothermia)<br>To investigate the safety and tolerability of limb hypothermia in subjects without cancer | Device: Hypothermia<br>* Healthy subjects will undergo 3 hours of hypothermia at various temperature levels.Cancer subjects will undergo 4 hours of hypothermia during every cycle of chemotherapy.<br>|
| Experimental: Healthy subjects (Cryocompresion)<br>To investigate the safety and tolerability of cryocompression in subjects without cancer | Device: Cryocompression<br>* Healthy subjects will undergo 3 hours of cryocompression. Cancer subjects will undergo a minimum duration of 2 hours and a maximum duration of up to 4 hours of cryocompression during every cycle of chemotherapy.<br>|
| Experimental: Cancer subjects (Hypothermia)<br>To investigate the safety and tolerability of limb hypothermia in subjects with breast cancer being treated with paclitaxel chemotherapy. | Device: Hypothermia<br>* Healthy subjects will undergo 3 hours of hypothermia at various temperature levels.Cancer subjects will undergo 4 hours of hypothermia during every cycle of chemotherapy.<br>|
| Experimental: Cancer subjects (Cryocompresion)<br>To investigate the safety and tolerability of cryocompression in subjects with cancer being treated with taxane-based chemotherapy. | Device: Cryocompression<br>* Healthy subjects will undergo 3 hours of cryocompression. Cancer subjects will undergo a minimum duration of 2 hours and a maximum duration of up to 4 hours of cryocompression during every cycle of chemotherapy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of healthy subjects with treatment-related intolerance as assessed by CTCAE v4.0 and tolerability scales undergoing limb hypothermia or cryocompression |  | From the start of assessment until study completion, an average of 3 years | 
| Number of cancer patients with treatment-related intolerance as assessed by CTCAE v4.0 and tolerability scales undergoing limb hypothermia or cryocompression |  | From the start of assessment until study completion, an average of 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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paclitaxel, neuropathy, hypothermia, cryocompression