Evidence map›Paper›PMID 37608354›Full record

ArticleTrials2023

Complex physical therapy employing self-adjusting garment (ReadyWrap®) in breast cancer-related lymphedema cases in Brazilian women: a protocol for a randomized controlled trial.

Jéssica Malena Pedro da Silva, Raul Denner Duarte Araújo, Francisca Cristina da Silva Santos, Erica Alves Nogueira Fabro, Marcus Vinicius de Mello Pinto, Suzana Sales de Aguiar, Luiz Claudio Santos Thuler, Anke Bergmann

2 registry-linked trialsOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2023. 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 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.7field-weighted citation impact, top 23% 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.

NCT04881604 nacompletednot on this map

Compressive Therapy by Adjustable Compression Garment (Ready Wrap®) in Breast Cancer-related Lymphedema: Randomized Clinical Trial

TypeinterventionalSponsorInstituto Nacional de Cancer, BrazilRan2021 to 2023Enrolled72ConditionsBreast Cancer Related Lymphedema, Lymphedema, Secondary, Lymphedema of Upper Arm, Breast NeoplasmsArmsAdjustable Compression Wrap, Compression Sleeve
NCT04934098 nacompletednot on this map

Compressive Therapy by Adjustable Compression Garment (Ready Wrap®) in Breast Cancer-related Lymphedema: Randomized Clinical Trial

TypeinterventionalSponsorInstituto Nacional de Cancer, BrazilRan2021 to 2024Enrolled72ConditionsBreast Cancer Related Lymphedema, Lymphedema, Secondary, Lymphedema of Upper Arm, Breast NeoplasmsArmsAdjustable Compression Wrap, Compression Bandage
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 3 citations in OpenAlex.

  1. 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

8 authors at 1 institution in 1 country.

Jéssica Malena Pedro da SilvaDivision of Clinical Research and Technological Development, Brazilian National Cancer Institute (INCA), Rio de Janeiro, RJ, Brazil.
Raul Denner Duarte AraújoDivision of Clinical Research and Technological Development, Brazilian National Cancer Institute (INCA), Rio de Janeiro, RJ, Brazil.
Francisca Cristina da Silva SantosDivision of Clinical Research and Technological Development, Brazilian National Cancer Institute (INCA), Rio de Janeiro, RJ, Brazil.
Erica Alves Nogueira FabroDivision of Clinical Research and Technological Development, Brazilian National Cancer Institute (INCA), Rio de Janeiro, RJ, Brazil.
Marcus Vinicius de Mello PintoInstitute Celulare, Rio de Janeiro, RJ, Brazil.
Suzana Sales de AguiarDivision of Clinical Research and Technological Development, Brazilian National Cancer Institute (INCA), Rio de Janeiro, RJ, Brazil.
Luiz Claudio Santos ThulerDivision of Clinical Research and Technological Development, Brazilian National Cancer Institute (INCA), Rio de Janeiro, RJ, Brazil.
Anke BergmannDivision of Clinical Research and Technological Development, Brazilian National Cancer Institute (INCA), Rio de Janeiro, RJ, Brazil. abergmann@inca.gov.br.ORCID http://orcid.org/0000-0002-1972-8777
Instituto Nacional de Câncer - INCA · BR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundLymphedema is a common complication following breast cancer treatment. The aim of this study is to evaluate the effectiveness of a self-adjusting compression garment (ReadyWrap®) in reducing (phase 1) and maintaining (phase 2) upper limb volume in women presenting breast cancer-related lymphedema.

methodsThis study will comprise a randomized, controlled, single-blind clinical trial concerning women with breast cancer-related lymphedema undergoing treatment at a public cancer treatment reference hospital in the city of Rio de Janeiro, Brazil. The intervention will be carried out by adapting self-dressing versus the standard treatment of compressive bandaging (phase 1) and compressive mesh (phase 2). Both groups will be assessed at the beginning and end of intensive treatment and followed up for up to 12 months to evaluate immediate and late outcomes. Assessments will be carried out by physical upper limb examination (inspection, palpation, volume, dynamometry, and thermography) and questionnaires application to assess patient's quality of life pertaining to the health, functionality, and symptoms of the affected upper limb, as well adverse effects and adherence to treatment. Data will be analyzed descriptively and analytically through univariate and multiple linear regressions. P values < 0.05 will be considered statistically significant. DISCUSSION: This study will evaluate the effectiveness of a self-adjustable garment (ReadyWrap®) in the treatment of lymphedema secondary to breast cancer in Brazilian women compared to the gold standard treatment for limb volume reduction (phase 1) and maintenance (phase 2) phases comprising, respectively, a compressive bandaging and a compressive mesh. The outcome results will provide data based on both quantitative responses and self-reported participant outcomes. The study will also assess the cost-effectiveness of the ReadyWrap® treatment versus standard care. Finally, we expect to reaffirm one more product/therapy as a treatment for this extremely complex and impactful condition following the data analysis.

trial registrationNCT04934098 [Clinical trials phase 1]. Registered on June 22, 2021. NCT04881604 [Clinical trials phase 2]. Registered on May 11, 2021.

Indexed as

Breast Cancer LymphedemaBreast NeoplasmsLymphedemaBrazilFemaleHumansPhysical Therapy ModalitiesQuality of LifeRandomized Controlled Trials as TopicSingle-Blind MethodBreast cancer lymphedemaCompression bandagesPhysiotherapyRehabilitation medicine

Identifiers

PMID37608354
PMCPMC10464195
OpenAlexW4386048114

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.