Quality of life in a phase 2 trial of short-course hyperthermic intraperitoneal chemotherapy (HIPEC) at interval debulking surgery for high tumor burden ovarian cancer.


Journal

Revista do Colegio Brasileiro de Cirurgioes
ISSN: 1809-4546
Titre abrégé: Rev Col Bras Cir
Pays: Brazil
ID NLM: 7809515

Informations de publication

Date de publication:
2020
Historique:
received: 19 03 2020
accepted: 27 04 2020
entrez: 16 7 2020
pubmed: 16 7 2020
medline: 28 7 2020
Statut: ppublish

Résumé

to evaluate the effect of short-course (i.e.: 30 minutes) HIPEC on health-related quality of life (HRQoL) in our feasibility study; NCT02249013. a prespecified secondary end-point of our open-label, multicenter, single-arm, phase 2 trial on safety and efficacy was assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30, version 3.0). Patients were required to complete the HRQoL questionnaire at baseline, after HIPEC, and after the end of the treatment. Changes of HRQoL over time were assessed by median scores for each domain and analyzed by Friedman`s test at a significant two-sided level of 0.05. fifteen patients with high tumor burden EOC were recruited from our public health system between February 2015 and July 2019. A baseline EORTC QLQ-C30 questionnaire and at least one follow-up questionnaire was received from all of the patients. No significant difference over time in the QLQC30 summary scores was observed (p>0.05). The transitory impairment on patients HRQoL immediately after the short-course HIPEC trended to return to baseline at the end of the multimodal treatment. we found no significant impairment of short-course HIPEC on patients HRQoL into the context of our comprehensive treatment protocol.

Identifiants

pubmed: 32667582
pii: S0100-69912020000100184
doi: 10.1590/0100-6991e-20202534
pii:
doi:

Banques de données

ClinicalTrials.gov
['NCT02249013']

Types de publication

Clinical Trial, Phase II Journal Article Multicenter Study

Langues

por eng

Sous-ensembles de citation

IM

Pagination

e20202534

Auteurs

Roberto JosÉ Costa Lustosa (RJC)

Departamento de Cirurgia, Instituto de Medicina Integral Professor Fernando Figueira, Recife, PE, Brazil.

Thales Paulo Batista (TP)

Departamento de Cirurgia, Instituto de Medicina Integral Professor Fernando Figueira, Recife, PE, Brazil.

VandrÉ Cabral Gomes Carneiro (VCG)

Departamento de Cirurgia / Oncologia, Instituto de Medicina Integral Professor Fernando Figueira, Recife, PE, Brazil.

Levon Badiglian-Filho (L)

Departamento de Ginecologia, AC Camargo Cancer Center, São Paulo, SP, Brazil.

Ronaldo LÚcio Rangel Costa (RLR)

Departamento de Ginecologia, Instituto Brasileiro de Controle do Câncer, São Paulo, SP, Brasil.

AndrÉ Lopes (A)

Departamento de Ginecologia, Instituto Brasileiro de Controle do Câncer, São Paulo, SP, Brasil.

Bruno JosÉ DE Queiroz Sarmento (BJQ)

Departamento de Oncologia Cirúrgica, Instituto Hospital de Base do Distrito Federal, Brasília, DF, Brasil.

Jurema Telles DE Oliveira Lima (JTO)

Departamento de Oncologia Clínica, Instituto de Medicina Integral Professor Fernando Figueira, Recife, PE, Brazil.

Maria Julia GonÇalves DE Mello (MJG)

Departamento de Pesquisa Clínica, Instituto de Medicina Integral Professor Fernando Figueira, Recife, PE, Brazil.

Cristiano Souza LeÃo (CS)

Departamento de Cirurgia, Instituto de Medicina Integral Professor Fernando Figueira, Recife, PE, Brazil.

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