PREventing CHemotherapy Induced Neuropathy (PreChIN)

National University Health System (NUHS)

Status: Completed

Conditions: Chemotherapy-induced Peripheral Neuropathy (CIPN)

Treatments: Device: Cryocompression; Device: Hypothermia

Study type: Interventional

Funder types: Other

Identifiers

NCT03299582

2013/00343

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 89 patients

Sex: All

Ages: 21 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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89 participants in 4 patient groups

Healthy subjects (Hypothermia)

Experimental group

Description:

To investigate the safety and tolerability of limb hypothermia in subjects without cancer

Treatment:

Device: Hypothermia

Healthy subjects (Cryocompresion)

Experimental group

Description:

To investigate the safety and tolerability of cryocompression in subjects without cancer

Treatment:

Device: Cryocompression

Cancer subjects (Hypothermia)

Experimental group

Description:

To investigate the safety and tolerability of limb hypothermia in subjects with breast cancer being treated with paclitaxel chemotherapy.

Treatment:

Device: Hypothermia

Cancer subjects (Cryocompresion)

Experimental group

Description:

To investigate the safety and tolerability of cryocompression in subjects with cancer being treated with taxane-based chemotherapy.

Treatment:

Device: Cryocompression