PREventing CHemotherapy Induced Neuropathy (PreChIN)

NCT03299582 | Completed

• 1 other identifier: 2013/00343
• Study Type: interventional
• Target: 89
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Chemotherapy-induced Peripheral Neuropathy (CIPN)

Keywords

paclitaxel; neuropathy; hypothermia; cryocompression

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (4)

Healthy subjects (Hypothermia)

EXPERIMENTAL

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

Device: Hypothermia

Healthy subjects (Cryocompresion)

EXPERIMENTAL

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

Device: Cryocompression

Cancer subjects (Hypothermia)

EXPERIMENTAL

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

Device: Hypothermia

Cancer subjects (Cryocompresion)

EXPERIMENTAL

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

Device: Cryocompression

Interventions

Hypothermia DEVICE

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.

Cancer subjects (Hypothermia); Healthy subjects (Hypothermia)

Cryocompression DEVICE

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.

Cancer subjects (Cryocompresion); Healthy subjects (Cryocompresion)

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 21- 80 years.
• Signed informed consent from patient or legal representative.
• Scheduled to receive taxane-based chemotherapy

You may not qualify if:

• 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

Sponsors & Collaborators

• National University Hospital, Singapore: lead

Related Publications (2)

• Tomchuk D, Rubley MD, Holcomb WR, Guadagnoli M, Tarno JM. The magnitude of tissue cooling during cryotherapy with varied types of compression. J Athl Train. 2010 May-Jun;45(3):230-7. doi: 10.4085/1062-6050-45.3.230.

  PMID: 20446835 BACKGROUND

• Murgier J, Cassard X. Cryotherapy with dynamic intermittent compression for analgesia after anterior cruciate ligament reconstruction. Preliminary study. Orthop Traumatol Surg Res. 2014 May;100(3):309-12. doi: 10.1016/j.otsr.2013.12.019. Epub 2014 Mar 25.

  PMID: 24679367 BACKGROUND

MeSH Terms

Conditions

Hypothermia

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Amanda Chan

  National University Hospital, Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 11, 2017
• First Posted: October 3, 2017
• Study Start: June 13, 2013
• Primary Completion: November 3, 2016
• Study Completion: February 15, 2017
• Last Updated: October 3, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share