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PREventing CHemotherapy Induced Neuropathy (PreChIN)

NCT ID: NCT03299582

Last Updated: 2017-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

89 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-13

Study Completion Date

2017-02-15

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.

Conditions

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Chemotherapy-induced Peripheral Neuropathy (CIPN)

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

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 Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Healthy subjects (Hypothermia)

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

Group Type EXPERIMENTAL

Hypothermia

Intervention Type 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.

Healthy subjects (Cryocompresion)

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

Group Type EXPERIMENTAL

Cryocompression

Intervention Type 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 (Hypothermia)

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

Group Type EXPERIMENTAL

Hypothermia

Intervention Type 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 (Cryocompresion)

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

Group Type EXPERIMENTAL

Cryocompression

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Age 21-80 years
* Signed informed consent from patient
* No history of neuropathy
* ECOG 0
* No history of hospitalization in the past 6 months


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

Exclusion Criteria

* 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
Minimum Eligible Age

21 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National University Hospital, Singapore

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Amanda Chan

Role: PRINCIPAL_INVESTIGATOR

National University Hospital, Singapore

References

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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.

Reference Type BACKGROUND
PMID: 20446835 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24679367 (View on PubMed)

Other Identifiers

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2013/00343

Identifier Type: -

Identifier Source: org_study_id