AzTrials
AzTrials

Cryotherapy EffectNCT04558034

The Use of Cryotherapy to Prevent Paclitaxel-induced Peripheral Neuropathy and Nail Changes in Women With Breast Cancer

A study testing cryotherapy in people with Cryotherapy Effect and Peripheral Neuropathy, run by Parkview Health at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

This study will determine the efficacy of cryotherapy to prevent paclitaxel-induced peripheral neuropathy and nail changes in women with breast cancer. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
cryotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
1 siteUnited States
Study dates
4 Aug 2020to 3 Feb 2021
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 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Females 18 or older
  • Histologically confirmed diagnosis of breast cancer
  • Receiving neo-adjuvant or adjuvant dose-dense anthracycline (AC) plus taxane-based chemotherapy or paclitaxel in combination with trastuzumab and pertuzumab

Who cannot join

  • Prior taxane therapy
  • Prior oxaliplatin therapy
  • Non-English speaking
  • History of peripheral neuropathy, i.e., Buerger's disease
  • History of diabetes mellitus
  • Pre-existing peripheral neuropathy from other conditions, e.g., Raynaud's disease, Guillain-Barre, Miller Fisher Syndrome
Show all 9Show fewer
  • Hand, nail or foot conditions, e.g., hand/foot syndrome, arthritis, hammer toe, carpal tunnel, bunions, deformities
  • Alcohol abuse (history/current)
  • Current medication usage of opioids, anti-depressants, anti-convulsants, glutamines, vitamin B12

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Parkview Cancer Institute

    Fort Wayne, Indiana, 46845

Other trials in United States

About this study

This study will determine the efficacy of cryotherapy to prevent paclitaxel-induced peripheral neuropathy and nail changes in women with breast cancer.

Read the detailed description

Women with breast cancer receiving paclitaxel will complete the Brief Pain Inventory(BPI), Neuropathic Pain Syndrome Inventory (NPSI)while a member of the research team will conduct an assessment of their nails. Once complete, cryotherapy will be administered 15 minutes prior to the paclitaxel infusion, continuously during and then 15 minutes after completion of the paclitaxel for a total of 90 minutes. Cyrotherapy will be delivered using Elasto-gel mitts and Rapid relief slippers. These items will be changed 45min after initiation to ensure coldness.

There will be two arms of the study. One arm will include subjects who will wear one slipper/one mitt on their foot/hand while the other foot/hand will serve as a control. The other arm will include subjects who will have cryotherapy to both hands and feet. . This process will be repeated for a total of 12 times in conjunction with 12 doses of paclitaxel. At time point 13, during a routine visit to their oncologist, the subjects nails will be reassessed along with completion of the BPI and NPSIA total of 25 subjects will be enrolled in each arm.

Being tested
cryotherapy
Medical subject headings
Peripheral Nervous System Diseases

What participants receive

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

  • cryotherapyOther

    cryotherapy will be delivered

Study groups in NCT04558034
Study groupRoleWhat they receive
Interventioncryotherapy/controlActive comparatorSubjects will have one mitt/one slipper and serve as their own control
Receives: Other: cryotherapy
standard of careNo interventionSubjects will have two mitts/slippers

What is being measured

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

  1. Numbness,tingling,pain ,nail toxicities

    absence of numbness and tingling in the treated hands/feet

    • If there is an absence of pain in the treated hands/feet
    • If there is an absence of nail changes in the treated hands/feet

    Measured: 13 weeks

Timeline

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

  1. First posted22 Sep 2020
  2. Study start4 Aug 2020
  3. Primary completion3 Feb 2021
  4. Study completion3 Feb 2021

Why it stopped: Principal Investigator retired before study completed.

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
Parallel groups
Model description
There are 2 arms to the study.The Elasto-gel mitt and Rapid Relief slipper will be placed either on one hand/foot or both based on the patient's medical oncologist. All subjects will have a standardized onset/duration of therapy which includes the following : * 15 minutes prior to the paclitaxel infusion, * Continuously during the paclitaxel infusion, * 15 minutes after completion of paclitaxel for a total of 90 minutes.
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04558034
Sponsor's protocol ID
NUR20-0124CRYO
Status last verified
Mar 2021
First submitted
3 Sep 2020
Last updated
8 Mar 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The following will be shared: Individual participant data that underlie the results reported in the planned article after deidentification including text,tables,figures, appendices

Publications

  • Alessandrini A, Starace M, Cere G, Brandi N, Piraccini BM. Management and Outcome of Taxane-Induced Nail Side Effects: Experience of 79 Patients from a Single Centre. Skin Appendage Disord. 2019 Aug;5(5):276-282. doi: 10.1159/000497824. Epub 2019 Mar 22.

    PubMed 31559250

  • Autissier E. Chemotherapy-Induced Peripheral Neuropathy: Association With Increased Risk of Falls and Injuries. Clin J Oncol Nurs. 2019 Aug 1;23(4):405-410. doi: 10.1188/19.CJON.405-410.

    PubMed 31322611

  • Argyriou AA, Kyritsis AP, Makatsoris T, Kalofonos HP. Chemotherapy-induced peripheral neuropathy in adults: a comprehensive update of the literature. Cancer Manag Res. 2014 Mar 19;6:135-47. doi: 10.2147/CMAR.S44261. eCollection 2014.

    PubMed 24672257

  • Bandos H, Melnikow J, Rivera DR, Swain SM, Sturtz K, Fehrenbacher L, Wade JL 3rd, Brufsky AM, Julian TB, Margolese RG, McCarron EC, Ganz PA. Long-term Peripheral Neuropathy in Breast Cancer Patients Treated With Adjuvant Chemotherapy: NRG Oncology/NSABP B-30. J Natl Cancer Inst. 2018 Feb 1;110(2):djx162. doi: 10.1093/jnci/djx162.

    PubMed 28954297

  • Bouhassira D, Attal N, Fermanian J, Alchaar H, Gautron M, Masquelier E, Rostaing S, Lanteri-Minet M, Collin E, Grisart J, Boureau F. Development and validation of the Neuropathic Pain Symptom Inventory. Pain. 2004 Apr;108(3):248-257. doi: 10.1016/j.pain.2003.12.024.

    PubMed 15030944

  • Bhatnagar B, Gilmore S, Goloubeva O, Pelser C, Medeiros M, Chumsri S, Tkaczuk K, Edelman M, Bao T. Chemotherapy dose reduction due to chemotherapy induced peripheral neuropathy in breast cancer patients receiving chemotherapy in the neoadjuvant or adjuvant settings: a single-center experience. Springerplus. 2014 Jul 16;3:366. doi: 10.1186/2193-1801-3-366. eCollection 2014.

    PubMed 25089251

  • Can G, Aydiner A, Cavdar I. Taxane-induced nail changes: Predictors and efficacy of the use of frozen gloves and socks in the prevention of nail toxicity. Eur J Oncol Nurs. 2012 Jul;16(3):270-5. doi: 10.1016/j.ejon.2011.06.007. Epub 2011 Jul 23.

    PubMed 21784705

  • Capriotti K, Capriotti JA, Lessin S, Wu S, Goldfarb S, Belum VR, Lacouture ME. The risk of nail changes with taxane chemotherapy: a systematic review of the literature and meta-analysis. Br J Dermatol. 2015 Sep;173(3):842-5. doi: 10.1111/bjd.13743. Epub 2015 Jul 29. No abstract available.

    PubMed 25704465

  • Chan YN, Jheng YW, Wang PJ, Chen CY, Lin MW, Wang YJ. Taxane-Induced Peripheral Neuropathy: Objective and Subjective Comparison Between Paclitaxel and Docetaxel in Patients With Breast Cancer. Clin J Oncol Nurs. 2019 Oct 1;23(5):494-501. doi: 10.1188/19.CJON.494-501.

    PubMed 31538967

  • Cassidy J, Misset JL. Oxaliplatin-related side effects: characteristics and management. Semin Oncol. 2002 Oct;29(5 Suppl 15):11-20. doi: 10.1053/sonc.2002.35524.

    PubMed 12422304

  • Childress J, Lokich J. Cutaneous hand and foot toxicity associated with cancer chemotherapy. Am J Clin Oncol. 2003 Oct;26(5):435-6. doi: 10.1097/01.coc.0000026486.56886.18. No abstract available.

    PubMed 14528066

  • Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singap. 1994 Mar;23(2):129-38.

    PubMed 8080219

  • Cioroiu C, Weimer LH. Update on Chemotherapy-Induced Peripheral Neuropathy. Curr Neurol Neurosci Rep. 2017 Jun;17(6):47. doi: 10.1007/s11910-017-0757-7.

    PubMed 28421360

  • Cunningham D, Gilchrist NL, Forrest GJ, Soukop M. Onycholysis associated with cytotoxic drugs. Br Med J (Clin Res Ed). 1985 Mar 2;290(6469):675-6. doi: 10.1136/bmj.290.6469.675-a. No abstract available.

    PubMed 2578850

  • Daut RL, Cleeland CS. The prevalence and severity of pain in cancer. Cancer. 1982 Nov 1;50(9):1913-8. doi: 10.1002/1097-0142(19821101)50:93.0.co;2-r.

    PubMed 7116316

Questions about this trial

What is this clinical trial studying?

A study testing cryotherapy in people with Cryotherapy Effect and Peripheral Neuropathy, run by Parkview Health at 1 site in United States.

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

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. 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: stopped early, as of the sponsor's last update on 8 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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 was stopped early (reason given: Principal Investigator retired before study completed.). Results are not available in the source record.

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?

Numbness,tingling,pain ,nail toxicities (time frame: 13 weeks). 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 NCT04558034, which also lists 69 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 8 Mar 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in