Evidence map›Paper›PMID 27875526›Full record

Trial reportBritish journal of cancer2017

Caphosol for prevention of oral mucositis in pediatric myeloablative haematopoietic cell transplantation.

Nathaniel Treister, Michael Nieder, Christina Baggott, Ellen Olson, Lu Chen, Ha Dang, Mark Krailo, Amanda August, Lillian Sung

Registry-linked trialOpen access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in British journal of cancer, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01305200 (A Randomized Double Blinded Trial of Topical Caphosol to Prevent Oral Mucositis in Children Undergoing Hematopoietic Stem Cell Transplantation), which is not on this map. Cited by 17 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 3 pooled it
2.3field-weighted citation impact, top 11% 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.

NCT01305200 phase3completednot on this map

A Randomized Double Blinded Trial of Topical Caphosol to Prevent Oral Mucositis in Children Undergoing Hematopoietic Stem Cell Transplantation

TypeinterventionalSponsorChildren's Oncology GroupRan2011 to 2015Enrolled226ConditionsChildhood Acute Lymphoblastic Leukemia in Remission, Childhood Acute Myeloid Leukemia in Remission, Childhood Chronic Myelogenous Leukemia, Childhood Myelodysplastic SyndromesArmssupersaturated calcium phosphate rinse, placebo, questionnaire administration, quality-of-life assessment
3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 3 syntheses or guidelines pooled it, 28 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Trial
  6. Article
  7. Review
  8. Nursing care approaches to oral mucositis in pediatric oncology clinics: a cross-sectional study from Türkiye.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2023
    Article
  9. Article
  10. Article
  11. Article
  12. Article
  13. Review
  14. Article
  15. Oncological-Therapy Related Oral Mucositis as an Interdisciplinary Problem-Literature Review.International journal of environmental research and public health · 2020
    Review
  16. Article
  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

9 authors at 8 institutions in 2 countries.

Nathaniel TreisterDivision of Oral Medicine and Dentistry, Brigham and Women's Hospital, Boston, MA, USA.
Michael NiederBlood and Marrow Transplant Department, Moffitt Cancer Center, Tampa, FL and Johns Hopkins All Children's Hospital, St Petersburg, FL, USA.
Christina BaggottPediatric Hematology-Oncology, Stanford Medical Center, Stanford, CA, USA.
Ellen OlsonAflac Cancer and Blood Disorders Service, Children's Healthcare of Atlanta, Atlanta, GA, USA.
Lu ChenChildren's Oncology Group, Monrovia, CA, USA.
Ha DangChildren's Oncology Group, Monrovia, CA, USA.
Mark KrailoChildren's Oncology Group, Monrovia, CA, USA.
Amanda AugustChildren's Mercy Hospital, Kansas City, MO, USA.
Lillian SungDivision of Haematology/Oncology, The Hospital for Sick Children, Toronto, Ontario, Canada.
Children's Oncology Group · USBrigham and Women's Hospital · USChildren's Healthcare of Atlanta · USChildren's Mercy Hospital · USHospital for Sick Children · CAJohns Hopkins University · USStanford Medicine · USUniversity of Southern California · US

Funding

NCTN BIQSFP ANBL1531 (NRT)U10CA180886 · NCI · PUBLIC HEALTH INSTITUTE · PI Douglas S. Hawkins · 2014 to 2026
$390.6M
COG FOREIGN ACCRUALU10CA098543 · NCI · NATIONAL CHILDHOOD CANCER FOUNDATION · PI ADAMSON, PETER C. · 2003 to 2013
$335.5M
COG SDMC - Statistics CoreU10CA180899 · NCI · UNIVERSITY OF SOUTHERN CALIFORNIA · PI TODD A ALONZO · 2014 to 2026
$132.8M
Children's Oncology Group Statistics &Data Center GrantU10CA098413 · NCI · UNIVERSITY OF NEBRASKA MEDICAL CENTER · PI ANDERSON, JAMES R · 2003 to 2013
$67.5M
Towards a preventive cancer vaccine for children with constitutional mismatch repair deficiencyUG1CA189955 · NCI · PUBLIC HEALTH INSTITUTE · PI BRAD H POLLOCK, Michael E. Roth · 2014 to 2026
$62.5M
NCI NIH HHS U10 CA098413NCI NIH HHS U10 CA098543NCI NIH HHS U10 CA180886NCI NIH HHS U10 CA180899NCI NIH HHS UG1 CA189955
6 · The paper itself

Abstract

backgroundThe primary objective was to determine whether topically administered Caphosol, rinsed orally four times daily at the initiation of conditioning, reduces the duration of severe oral mucositis (OM) compared with placebo among children and adolescents undergoing haematopoietic cell transplantation (HCT).

methodsThis was a Children's Oncology Group multicentre randomised double-blinded placebo-controlled clinical trial. Patients between the ages of 4 and 21 years who were scheduled to undergo myeloablative HCT for any indication were randomised to Caphosol or placebo saline rinses four times daily from initiation of conditioning through day +20. Subjects were assessed daily for OM using the World Health Organisation (WHO) Oral Toxicity Scale, Mouth Pain Categorical Scale (0-10) and the Oral Mucositis Daily Questionnaire (OMDQ). The primary end point was duration of severe OM (WHO ⩾3).

resultsThe study enrolled 220 participants with a median age of 13.7 years (range 4.0-21.9); 163 (74%) received allogeneic HCT. The mean (±s.d.) duration of severe OM was not reduced among Caphosol (4.5±5.0 days) vs placebo (4.5±4.8; P=0.99) recipients. The incidence of severe OM in the Caphosol and placebo arms was 63% (57 out of 91) and 68% (62 out of 91), respectively (P=0.44). There were no significant differences in any of the secondary end points between the groups.

conclusionsCaphosol did not reduce severe OM when compared with placebo among children and adolescents undergoing myeloablative HCT. Studies to identify effective interventions for OM are needed in this population.

Indexed as

Hematopoietic Stem Cell TransplantationTransplantation ConditioningAdolescentAdultCalcium PhosphatesChildChild, PreschoolFemaleHumansHypertonic SolutionsMaleMyeloablative AgonistsStomatitisTransplantation, HomologousTreatment OutcomeYoung Adultcalcium phosphateCalcium PhosphatesHypertonic SolutionsMyeloablative Agonists

Identifiers

PMID27875526
PMCPMC5220147
OpenAlexW2551083370

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-SA
Read underepoch 390

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.