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PREventing CHemotherapy Induced Neuropathy (PreChIN)

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ClinicalTrials.gov Identifier: NCT03299582
Recruitment Status : Completed
First Posted : October 3, 2017
Last Update Posted : October 3, 2017
Sponsor:
Information provided by (Responsible Party):
National University Hospital, Singapore

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.

Condition or disease Intervention/treatment Phase
Chemotherapy-induced Peripheral Neuropathy (CIPN) Device: Hypothermia Device: Cryocompression Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 89 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
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.

Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: PREventing CHemotherapy Induced Neuropathy (PreChIN)
Actual Study Start Date : June 13, 2013
Actual Primary Completion Date : November 3, 2016
Actual Study Completion Date : February 15, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypothermia

Arm Intervention/treatment
Experimental: Healthy subjects (Hypothermia)
To investigate the safety and tolerability of limb hypothermia in subjects without cancer
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.

Experimental: Healthy subjects (Cryocompresion)
To investigate the safety and tolerability of cryocompression in subjects without cancer
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.

Experimental: Cancer subjects (Hypothermia)
To investigate the safety and tolerability of limb hypothermia in subjects with breast cancer being treated with paclitaxel chemotherapy.
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.

Experimental: Cancer subjects (Cryocompresion)
To investigate the safety and tolerability of cryocompression in subjects with cancer being treated with taxane-based chemotherapy.
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.




Primary Outcome Measures :
  1. Number of healthy subjects with treatment-related intolerance as assessed by CTCAE v4.0 and tolerability scales undergoing limb hypothermia or cryocompression [ Time Frame: From the start of assessment until study completion, an average of 3 years ]
  2. Number of cancer patients with treatment-related intolerance as assessed by CTCAE v4.0 and tolerability scales undergoing limb hypothermia or cryocompression [ Time Frame: From the start of assessment until study completion, an average of 3 years ]


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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03299582


Sponsors and Collaborators
National University Hospital, Singapore
Investigators
Principal Investigator: Amanda Chan National University Hospital, Singapore

Publications:
Responsible Party: National University Hospital, Singapore
ClinicalTrials.gov Identifier: NCT03299582     History of Changes
Other Study ID Numbers: 2013/00343
First Posted: October 3, 2017    Key Record Dates
Last Update Posted: October 3, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by National University Hospital, Singapore:
paclitaxel
neuropathy
hypothermia
cryocompression

Additional relevant MeSH terms:
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases