Clinical trial NCT03299582: PREventing CHemotherapy Induced Neuropathy (PreChIN)
Official title: PREventing CHemotherapy Induced Neuropathy (PreChIN)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chemotherapy-induced Peripheral Neuropathy (CIPN)
Keywords: paclitaxel
neuropathy
hypothermia
cryocompression
Lead sponsor: National University Hospital, Singapore
Sponsor class: OTHER
First posted: 2017-10-03
Enrollment: 89
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention 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.
Primary purpose: PREVENTION

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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Number of healthy subjects with treatment-related intolerance as assessed by CTCAE v4.0 and tolerability scales undergoing limb hypothermia or cryocompression
timeFrame: From the start of assessment until study completion, an average of 3 years
measure: Number of cancer patients with treatment-related intolerance as assessed by CTCAE v4.0 and tolerability scales undergoing limb hypothermia or cryocompression
timeFrame: From the start of assessment until study completion, an average of 3 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: National University Hospital, Singapore
name: Amanda Chan
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.