PREventing CHemotherapy Induced Neuropathy (PreChIN)

Chemotherapy-induced Peripheral Neuropathy (CIPN) Clinical Trial

Official title:

PREventing CHemotherapy Induced Neuropathy (PreChIN)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03299582
• Other study ID #: 2013/00343
• Status: Completed
• Phase: N/A
• First received: September 11, 2017
• Last updated: October 1, 2017
• Start date: June 13, 2013
• Est. completion date: February 15, 2017

Study information

• Verified date: August 2017
• Source: National University Hospital, Singapore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: February 15, 2017
• Est. primary completion date: November 3, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Chemotherapy-induced Peripheral Neuropathy (CIPN)
• Peripheral Nervous System Diseases

Intervention

Device:
• Hypothermia
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.
• Cryocompression
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National University Hospital, Singapore

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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