Evidence map›Paper›PMID 38060077›Full record

Trial reportBreast cancer research and treatment2024

Randomized adaptive selection trial of cryotherapy, compression therapy, and placebo to prevent taxane-induced peripheral neuropathy in patients with breast cancer.

Melissa K Accordino, Shing Lee, Cheng Shiun Leu, Bruce Levin, Meghna S Trivedi, Katherine D Crew, Kevin Kalinsky, Rohit Raghunathan, Khadija Faheem, Erik Harden and 7 more

2 registry-linked trialsOpen access · greenAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Breast cancer research and treatment, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 17 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 1 pooled it
4.8field-weighted citation impact, top 4% 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.

NCT03873272 nacompletednot on this map

Randomized Controlled Selection Trial of Cryotherapy vs. Compression Therapy for the Prevention of Taxane-induced Peripheral Neuropathy in Breast Cancer Patients

TypeinterventionalSponsorColumbia UniversityRan2019 to 2023Enrolled63ConditionsCIPN - Chemotherapy-Induced Peripheral NeuropathyArmsCryotherapy, Compression Therapy, Loose glove/sock
NCT06733545 completednot on this map

Study for the Evaluation of the Degree of Skin Satisfaction of Cosmetics Creams PB-011 and PB-012 for Sensitive Skin in Oncological Patients Affected by a Palmoplantar Polyneuropathy Secondary to Chemotherapy or Chemotherapeutic Agents' Fusion to Monoclonal Antibodies (Immunocitostatics)

Typeobservational_patient_registrySponsorPROSPERA BIOTECH S.L.Ran2022 to 2024Enrolled120ConditionsQuality of Life (QOL), CIPN - Chemotherapy-Induced Peripheral Neuropathy
3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 1 synthesis or guideline pooled it, 21 citations in OpenAlex.

  1. Efficacy of cryotherapy in the prevention of chemotherapy-induced peripheral neuropathy: A systematic review and meta-analysis.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2024
    Pooled it
  2. Trial
  3. Trial
  4. A topical nociceutical formulation ameliorates chemotherapy-induced peripheral neuropathy: a pilot randomized clinical study.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026
    Trial
  5. Trial
  6. Clinical efficacy of compression therapy in preventing oxaliplatin-induced peripheral neuropathy: a prospective, randomized controlled study.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2025
    Trial
  7. Review
  8. Article
  9. Article
  10. Review
  11. Chemotherapy-induced peripheral neuropathy in breast cancer: a narrative review.Translational breast cancer research : a journal focusing on translational research in breast cancer · 2026
    Review
  12. Review
  13. Addressing the Needs of Breast Cancer Survivors.Current oncology reports · 2025
    Review
  14. 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
  15. Article
  16. Efficacy of compression therapy for prevention of peripheral neuropathy caused by taxane-based chemotherapy: a single-center retrospective observational study.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2025
    Observational
  17. Review
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

17 authors at 2 institutions in 1 country.

Melissa K AccordinoDivision of Hematology/Oncology, Department of Medicine, Columbia University Irving Medical Center, New York, NY, USA. Mkg2134@cumc.columbia.edu.ORCID http://orcid.org/0000-0002-4156-7279
Shing LeeHerbert Irving Comprehensive Cancer Center, Columbia University Irving Medical Center, 161 Ft Washington Ave #1071, New York, NY, 212-305-1945, USA.
Cheng Shiun LeuDepartment of Biostatistics, Columbia University Medical Center, New York, NY, USA.
Bruce LevinDepartment of Biostatistics, Columbia University Medical Center, New York, NY, USA.
Meghna S TrivediDivision of Hematology/Oncology, Department of Medicine, Columbia University Irving Medical Center, New York, NY, USA.
Katherine D CrewDivision of Hematology/Oncology, Department of Medicine, Columbia University Irving Medical Center, New York, NY, USA.
Kevin KalinskyDepartment of Hematology and Medical Oncology, Winship Cancer Institute, Emory University, Atlanta, GA, USA.
Rohit RaghunathanHerbert Irving Comprehensive Cancer Center, Columbia University Irving Medical Center, 161 Ft Washington Ave #1071, New York, NY, 212-305-1945, USA.
Khadija FaheemDivision of Hematology/Oncology, Department of Medicine, Columbia University Irving Medical Center, New York, NY, USA.
Erik HardenDivision of Hematology/Oncology, Department of Medicine, Columbia University Irving Medical Center, New York, NY, USA.
Alessandra TaboadaDivision of Hematology/Oncology, Department of Medicine, Columbia University Irving Medical Center, New York, NY, USA.
Beatriz Desanti de OliveiraDeparment of Medicine, Columbia University Medical Center, New York, NY, USA.
Elisabeth LarsonDivision of Hematology/Oncology, Department of Medicine, Columbia University Irving Medical Center, New York, NY, USA.
Lauren FranksDepartment of Biostatistics, Columbia University Medical Center, New York, NY, USA.
Erin HonanDivision of Hematology/Oncology, Department of Medicine, Columbia University Irving Medical Center, New York, NY, USA.
Cynthia LawDivision of Hematology/Oncology, Department of Medicine, Columbia University Irving Medical Center, New York, NY, USA.
Dawn L HershmanDivision of Hematology/Oncology, Department of Medicine, Columbia University Irving Medical Center, New York, NY, USA.
Columbia University Irving Medical Center · USEmory University · US

Funding

Cryotherapy and Compression Therapy to Prevent Chemotherapy Induced Peripheral Neuropathy in Breast Cancer PatientsR03CA238982 · NCI · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI ACCORDINO, MELISSA · 2020 to 2021
$162k
NCI NIH HHS 1R03CA238982-01A1NCI NIH HHS R03 CA238982
6 · The paper itself

Abstract

backgroundChemotherapy-induced peripheral neuropathy (CIPN) is a common and debilitating adverse effect of taxane therapy. Small non-randomized studies in patients with early-stage breast cancer (ESBC) suggest both cryotherapy and compression therapy may prevent CIPN. It is unknown which is more effective.

methodsWe conducted a randomized phase IIB adaptive sequential selection trial of cryotherapy vs. compression therapy vs. placebo ("loose" gloves/socks) during taxane chemotherapy. Participants were randomized in triplets. Garments were worn for 90-120 min, beginning 15 min prior and continuing for 15 min following the infusion. The primary goal was to select the best intervention based on a Levin-Robbins-Leu sequential selection procedure. The primary endpoint was a < 5-point decrease in the Functional Assessment of Cancer Therapy Neurotoxicity (FACT-NTX) at 12 weeks. An arm was eliminated if it had four or more fewer successes than the currently leading arm. Secondary endpoints included intervention adherence and patient-reported comfort/satisfaction.

resultsBetween April 2019 and April 2021, 63 patients were randomized (cryotherapy (20); compression (22); placebo (21)). Most patients (60.3%) were treated with docetaxel. The stopping criterion was met after the 17th triplet (n = 51) was evaluated; success at 12 weeks occurred in 11 (64.7%) on compression therapy, 7 (41.1%) on cryotherapy, and 7 (41.1%) on placebo. Adherence to the intervention was lowest with cryotherapy (35.0%) compared to compression (72.7%) and placebo (76.2%).

conclusionCompression therapy was the most effective intervention in this phase IIB selection trial to prevent CIPN and was well tolerated. Compression therapy for the prevention of CIPN should be evaluated in a phase III study. CLINICAL

trial registrationClinicaTrials.gov Identifier: NCT03873272.

Indexed as

Breast NeoplasmsPeripheral Nervous System DiseasesAntineoplastic AgentsBridged-Ring CompoundsCryotherapyFemaleHumansTaxoidsAntineoplastic AgentsBridged-Ring CompoundstaxaneTaxoidsChemotherapy-induced peripheral neuropathyCompression therapyCryotherapyTaxane chemotherapy

Identifiers

PMID38060077
PMCPMC10840989
OpenAlexW4389453202

What Socratic holds

Textmetadata
LicenceTDM
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Registered trials

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 Socratic graph.