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Chemotherapy-induced Peripheral Neuropathy (CIPN)NCT03299582

PREventing CHemotherapy Induced Neuropathy (PreChIN)

A study testing Hypothermia and Cryocompression in people with Chemotherapy-induced Peripheral Neuropathy (CIPN), run by National University Hospital, Singapore.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 21 to 80 yearsHealthy volunteers can take part
What is being tested?
Hypothermia and Cryocompression
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
89 participants
Where
No sites listed yet
Study dates
13 Jun 2013to 15 Feb 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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

About this study

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.

Read the 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.

Being tested
Hypothermia, Cryocompression
Keywords
paclitaxel, neuropathy, hypothermia, cryocompression
Medical subject headings
Hypothermia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HypothermiaDevice

    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.

  • CryocompressionDevice

    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.

Study groups in NCT03299582
Study groupRoleWhat they receive
Healthy subjects (Hypothermia)ExperimentalTo investigate the safety and tolerability of limb hypothermia in subjects without cancer
Receives: Device: Hypothermia
Healthy subjects (Cryocompresion)ExperimentalTo investigate the safety and tolerability of cryocompression in subjects without cancer
Receives: Device: Cryocompression
Cancer subjects (Hypothermia)ExperimentalTo investigate the safety and tolerability of limb hypothermia in subjects with breast cancer being treated with paclitaxel chemotherapy.
Receives: Device: Hypothermia
Cancer subjects (Cryocompresion)ExperimentalTo investigate the safety and tolerability of cryocompression in subjects with cancer being treated with taxane-based chemotherapy.
Receives: Device: Cryocompression

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of healthy subjects with treatment-related intolerance as assessed by CTCAE v4.0 and tolerability scales undergoing limb hypothermia or cryocompression

    Measured: 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

    Measured: From the start of assessment until study completion, an average of 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Oct 2017
  2. Study start13 Jun 2013
  3. Primary completion3 Nov 2016
  4. Study completion15 Feb 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Sequential
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)
Enrolment
89 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03299582
Sponsor's protocol ID
2013/00343
Status last verified
Aug 2017
First submitted
11 Sep 2017
Last updated
3 Oct 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 20446835

  • 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.

    PubMed 24679367

Questions about this trial

What is this clinical trial studying?

A study testing Hypothermia and Cryocompression in people with Chemotherapy-induced Peripheral Neuropathy (CIPN), run by National University Hospital, Singapore.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03299582, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2017.

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