Evidence map›Paper›PMID 40742459›Full record

Trial reportSupportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer2025

Multi-institutional, randomized, controlled trial to assess the efficacy and tolerability of a reusable, self-contained cryotherapy delivery device.

Richard Zuniga, Vikas Dembla, Naheed Alam, Chaitali Nangia, Thomas Guerrero-Garcia, Gina Chung, Ebenezer Kio, Mylene Go, Erev Tubb, Stephen Sonis and 1 more

Registry-linked trialAbstract readRandomized Controlled TrialMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04595838 (A Randomized, Prospective, Multi-center Trial to Assess the Efficacy of a Cryotherapy Device Versus Best Supportive Oral Care in Mitigating Symptoms of Oral Mucositis in Patients Receiving Chemotherapy for the Treatment of Cancer), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
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.

NCT04595838 nacompletednot on this map

A Randomized, Prospective, Multi-center Trial to Assess the Efficacy of a Cryotherapy Device Versus Best Supportive Oral Care in Mitigating Symptoms of Oral Mucositis in Patients Receiving Chemotherapy for the Treatment of Cancer

TypeinterventionalSponsorChemo MouthpieceRan2020 to 2023Enrolled176ConditionsOral MucositisArmsChemo Mouthpiece, Best Supportive Care only
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
  2. Review
  3. An economic analysis of Chemo MouthpieceJournal of comparative effectiveness research · 2026
    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.

Richard ZunigaNew York Cancer and Blood Specialists, Port Jefferson Station, NY, USA.
Vikas DemblaGibbs Cancer Center, Spartanburg, SC, USA.
Naheed AlamErie County Medical Center, Buffalo, NY, USA.
Chaitali NangiaHoag Memorial Hospital Presbyterian, Newport Beach, CA, USA.
Thomas Guerrero-GarciaPhelps Health, Rolla, MO, USA.
Gina ChungThe Christ Hospital, Cincinnati, OH, USA.
Ebenezer KioGoshen Center for Cancer Care, Goshen, IN, USA.
Mylene GoInspira Medical Center Vineland New Jersey Southern Oncology Hematology and Associates, Vineland, NJ, USA.
Erev TubbInspira Medical Center Mullica Hill, Mullica Hill, NJ, USA.
Stephen SonisDana-Farber Cancer Institute, Boston, MA, USA. ssonis@pesclinical.com.ORCID http://orcid.org/0000-0001-6480-2625
Frank JacobucciChemomouthpiece, LLC, Closter, NJ, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeCryotherapy is an effective mucositis intervention for selected chemotherapy regimens, but reliance on ice chips has limited its applicability. Our objective was to assess the efficacy and tolerability of a reusable, self-contained, device as an alternative delivery mode.

methodsA total of 164 patients randomized 2:1 received the device (Chemo Mouthpiece; CMP]) + best supportive care (BSC) (arm A) or BSC only (control, arm B), across 16 study sites. Inclusion criteria allowed broad tumor diagnosis and chemotherapy regimens. During the first two cycles of treatment, patients completed daily questionnaires in which they graded oral pain (OP) and analgesic use (AU) to control mouth pain. A questionnaire assessed device tolerability at the trial's end.

resultsThe majority of patients received chemotherapy for breast cancer (arm A 52.7%, arm B 61.1%). Colorectal cancers were the next most common diagnosis. The percentage of visits in which any OP (> 0) in cycles 1 and 2 was reported was less among device-using individuals (CMP 17.8% vs Control 24.6%; p < 0.001). Whereas 26% of controls (arm B) required analgesics during their two cycles of treatment, the frequency was 11.3% among arm A (p = 0.01). Arm B AU was reported in 7.7% of visits compared to 1.8% of arm A visits (p < 0.001). End-of-study assessments of device tolerability were favorable.

conclusionsCMP use for 14 days following chemotherapy infusion mitigated chemotherapy-associated OP and AU. The effect was seen over two cycles of treatment with known stomatotoxic agents having both short and long half-lives. The device was well tolerated.

trial registrationClinicalTrials.gov (NCT04595838) Posted August 31, 2020.

Indexed as

Antineoplastic AgentsCryotherapyNeoplasmsStomatitisAdultAgedAged, 80 and overAnalgesicsEquipment ReuseFemaleHumansMaleMiddle AgedSurveys and QuestionnairesAnalgesicsAntineoplastic AgentsBreast cancerChemotherapyCryotherapyDeviceOral mucositis

Identifiers

PMID40742459
PMCPMC12313755

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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 OpenQuestion graph.