CIPN - Clinical trial • Breast Cancer Foundation NZ

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CIPN

Recruiting
Updated: June 30, 2020

This study aims to assess the efficacy and safety of cryotherapy in preventing CIPN in patients receiving taxanes for breast or gynaecological cancer.

The purpose of this study to test cryotherapy (cold therapy) for preventing chemotherapy induced peripheral neuropathy (CIPN) in patients receiving taxane chemotherapy for treatment of cancer.

Primary outcome:

Compare the severity of patient reported neuropathy symptoms using the European Organization for Research and Treatment of Cancer (EORTC-QLQ-CIPN20) quality of life (QOL) questionnaire at baseline, at the completion of taxane chemotherapy, and 6 months following completion of taxane chemotherapy between cryotherapy treated patients and controls.

Secondary outcomes:

  • Assess the quality of life using the EORTC QLQ-C30 questionnaire at baseline, at the completion of taxane chemotherapy, and 6 months following completion of taxane chemotherapy between cryotherapy treated patients and controls.
  • Assess safety and tolerability of cryotherapy during and after treatment using National Cancer Institute (NCI CTCAE V5.0) grading system of adverse events.
  • Compare the incidence of patient self-reporting of falls in the 6 months following completion of taxane chemotherapy in the cryotherapy-treated versus the control groups.

Who is it for?

You may be eligible for this study if you are aged 18 or over and are receiving taxane therapy for breast or gynaecological cancer.

Study details

All participants in this study will continue receiving their chemotherapy as per the standard protocol. Two groups will be formed by random chance. One group will receive cryotherapy delivered by Ice Replacement pads (IRP) wrapped around both hands and feet. These pads will be changed every 30 minutes from 15 minutes before chemotherapy until 15 minutes after chemotherapy. The other group will have their chemotherapy without any cryotherapy.

All participants will answer questionnaires about their quality of life and any side-effects at the beginning of the study, at the end of chemotherapy and six months after completion of chemotherapy.

It is hoped this research will improve patient quality of life by demonstrating cryotherapy helps reduce CIPN, which is a potentially debilitating side effect of chemotherapy.

For full trial information

Australia

Mater Adult Hospital, Brisbane
Mater Private Hospital, Brisbane

Contact:

David Courtney-Rodgers

If you think you might be a candidate for this trial, use the contact details supplied, or talk to your doctor.

Want to access a trial that's not in your area? It's not always possible, but if you're interested, email us at intouch@bcf.org.nz

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