Evidence map›Paper›PMID 31590108›Full record

Trial reportBreast (Edinburgh, Scotland)2019

Randomized controlled trial of cryotherapy to prevent paclitaxel-induced peripheral neuropathy (RU221511I); an ACCRU trial.

Kathryn J Ruddy, Jennifer Le-Rademacher, Mario E Lacouture, Mary Wilkinson, Adedayo A Onitilo, Amy C Vander Woude, Maria T Grosse-Perdekamp, Travis Dockter, Angelina D Tan, Andreas Beutler and 1 more

Open access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Breast (Edinburgh, Scotland), 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 27 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed, 9 pooled it
2.0field-weighted citation impact, top 12% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

27 citing papers in PubMed, 9 syntheses or guidelines pooled it, 55 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Cryotherapy in Postoperative Shoulder Surgery: A Systematic Review.Therapeutic hypothermia and temperature management · 2024
    Pooled it
  4. Pooled it
  5. Pooled it
  6. Pooled it
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  8. Pooled it
  9. Pooled it
  10. Cooling the language on cryotherapy as an effective intervention to prevent or mitigate chemotherapy-induced peripheral neuropathy.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026
    Article
  11. Regional limb cooling for the prevention of chemotherapy-induced toxicities: a narrative review.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2025
    Review
  12. Review
  13. Article
  14. Safety and feasibility of concomitant scalp cooling and limb cryocompression to prevent paclitaxel-induced alopecia and neuropathy.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2025
    Article
  15. Patient-reported strategies for prevention and treatment of chemotherapy-induced peripheral neuropathy.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2025
    Article
  16. Review
  17. Review
  18. Measuring symptoms and toxicities: a 35-year experience.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2023
    Review
  19. Article
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 5 institutions in 1 country.

Kathryn J RuddyDepartment of Oncology, Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA. Electronic address: Ruddy.kathryn@mayo.edu.
Jennifer Le-RademacherDepartment of Biostatistics, Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA.
Mario E LacoutureDepartment of Dermatology, Memorial Sloan Kettering Cancer Center, 1275 York Ave., New York, NY, 10065, USA.
Mary WilkinsonInova Hematology Oncology, 8501 Arlington Blvd., Suite 340, Fairfax, VA, 22031, USA.
Adedayo A OnitiloMarshfield Clinic - Weston Center, 3501 Cranberry Blvd., Weston, WI, 54476, USA.
Amy C Vander WoudeCancer and Hematology Centers of Western Michigan, 145 Michigan St. NE, #3100, Grand Rapids, MI, 49503, USA.
Maria T Grosse-PerdekampCarle Cancer Center, 509 W. University Ave., Urbana, IL, 61801, USA.
Travis DockterDepartment of Biostatistics, Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA.
Angelina D TanDepartment of Biostatistics, Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA.
Andreas BeutlerDepartment of Oncology, Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA.
Charles L LoprinziDepartment of Oncology, Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA.
Mayo Clinic · USHematology Oncology Consultants · USInova Fairfax Hospital · USMarshfield Clinic Weston Center · USMemorial Sloan Kettering Cancer Center · US

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Hongbiao Carl Lekaye · 1985 to 2026
$347.4M
SEAL (Stopping Atopic dermatitis and ALlergy) Study: Prevent allergy by enhancing the skin barrierU01AI147462 · NIAID · STANFORD UNIVERSITY · PI Mary Johnson, GIDEON LACK · 2020 to 2026
$14.0M
Identification of pathways to mitigate Immune-Related Adverse Events with Cancer Immunotherapy U01AR077511 · NIAMS · NATIONAL JEWISH HEALTH · PI KERN, JEFFREY A, LACOUTURE, MARIO · 2020 to 2024
$3.1M
NCI NIH HHS P30 CA008748NIAID NIH HHS U01 AI147462NIAMS NIH HHS U01 AR077511
6 · The paper itself

Abstract

purposeThis pilot trial aimed to assess if cooling hands and feet with crushed ice during receipt of paclitaxel helps prevent peripheral neuropathy.

methodsThis prospective, randomized trial compared cryotherapy to standard care in patients initiating paclitaxel weekly x 12. For those on cryotherapy, hands and feet were cooled starting 15 min prior to and ending 15 min after each paclitaxel dose. EORTC QLQ-CIPN20 was completed at baseline, weekly x12, then monthly x6. Area under the curve (AUC) was calculated for subscale scores, adjusting for baseline, and compared between arms (Wilcoxon rank-sum test). Cross-study comparisons used data from 2 prior similarly-conducted neuropathy trials.

resultsForty-six patients were accrued. Three withdrew and one was ineligible. Of the remaining 42 (21 cryotherapy, 21 control), 39 (19 cryotherapy, 20 control) were analyzable for AUC. Cryotherapy was well tolerated, but the AUC of the CIPN20 sensory scores over 12 weeks of paclitaxel was not found to differ between the study arms (mean difference 3.45, 95% CI -3.13 to 10.02, p = 0.26). However, the control arm of the current trial experienced less neuropathy than did the placebo arms of two previous similar trials. When our cryotherapy arm was compared to the combined control arms from all three trials, the cryotherapy arm had less neuropathy (Wilcoxon Rank-Sum p = 0.01).

conclusionWhile there was no difference in CIPN20 scores identified between the 2 study arms in the current phase II trial, further investigation is needed given that the control arm experienced less neuropathy than was expected.

Indexed as

CryotherapyAgedAntineoplastic Agents, PhytogenicBreast NeoplasmsFemaleFootHandHumansMiddle AgedPaclitaxelPeripheral Nervous System DiseasesPilot ProjectsProspective StudiesAntineoplastic Agents, PhytogenicPaclitaxelChemotherapy-induced neuropathyCryotherapyPaclitaxel acute pain syndromePaclitaxel-associated neuropathy

Identifiers

PMID31590108
PMCPMC7558814
OpenAlexW2973936581

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.