Pilot study evaluating broccoli sprouts in advanced pancreatic cancer (POUDER trial) - study protocol for a randomized controlled trial
Lozanovski VJ, Houben P, Hinz U, Hackert T, Herr I, Schemmer P
Trials · 33 citas
Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Eventos clínicos como enfermedad o muerte
- Consumo medido con
- No se indica
Quién lo pagó
- Financiación
- Financiación independiente
- Organización sin fines de lucro
- Heidelberger Stiftung Chirurgie
Según 1 financiador declarado y la declaración de financiación del texto completo.
Publicación
- Publicado
- 2014-06-03 · Trials · vol. 15 · número 1 · pág. 204
- Editorial
- Springer Science+Business Media
- Citado
- 49 citas · más que el 87% de estudios similares · 1.9× el promedio de su campo
- Referencias
- 42 trabajos
- Acceso
- Acceso abierto (revista) · CC-BY
- Áreas de investigación
- Pancreatic and Hepatic Oncology Research · Genomics, phytochemicals, and oxidative stress · Pineapple and bromelain studies
- Palabras clave
- broccoli sprouts, sulforaphane, isothiocyanates, pancreatic ductal adenocarcinoma, advanced pancreatic cancer, cancer stem cells, palliative chemotherapy, dietary supplements, serum tumor markers, CA19-9, carcinoembryonic antigen, quality of life, overall survival, clinical feasibility
- MeSH
- humans, brassica, carcinoma, pancreatic ductal, pancreatic neoplasms, antineoplastic agents, survival rate, follow-up studies, prospective studies, pilot projects, double-blind method, research design, adult, neoplastic stem cells, biomarkers, tumor
6 autores
- Vladimir J. Lozanovski🇩🇪Heidelberg University; University Hospital Heidelberg
- Philipp Houben🇩🇪Heidelberg University; University Hospital Heidelberg
- Ulf Hinz🇩🇪Heidelberg University; University Hospital Heidelberg
- Thilo Hackert🇩🇪Heidelberg University; University Hospital Heidelberg
- Ingrid Herr🇩🇪 · autor de correspondenciaHeidelberg University; University Hospital Heidelberg
- Peter Schemmer🇩🇪 · autor de correspondenciaHeidelberg University; University Hospital Heidelberg
Resumen
El texto original del estudio, en el idioma en que se publicó.
Background
Pancreatic ductal adenocarcinoma (PDA) is one of the most aggressive malignancies with marked resistance to chemo- and radiotherapy. PDA-cancer stem cells (CSCs) are not targeted by current therapies and may be a reason for poor prognosis. Studies indicate that diets rich in cabbage, broccoli, and cauliflower offer cancer preventative and therapeutic benefits. Recent experimental studies have confirmed these findings and demonstrated that isothiocyanate, sulforaphane, and the polyphenol, quercetin, effectively reduced tumor growth and enhanced the sensitivity of the cancer cells to current chemotherapeutics. The aim of the present study is to test the feasibility of a randomized controlled trial on the application of freeze-dried broccoli sprouts in patients with advanced PDA.
Methods and study design
The study is designed as a prospective randomized, double-blinded pilot trial with a treatment and a placebo-controlled arm in a single center setting. A total number of forty patients (18 years or older) in two parallel groups with advanced, surgically non-resectable PDA under palliative chemotherapy are planned for recruitment. Patients in the treatment group will receive fifteen capsules of the study substance per day (90 mg of active sulforaphane) during the chemotherapy treatment course. Patients in the placebo group will receive the same capsule size and portion distribution with inactive substances (mainly methylcellulose). The follow-up duration is one year. Feasibility of the study substance, adverse effects, and patient compliance, as well as levels of serum tumor markers (CEA, CA 19-9), quality of life, and patient overall survival rates will be assessed at defined points of time.
Discussion
The POUDER trial is expected to transfer promising experimental and epidemiological data into a clinical pilot study to assess the effectiveness of broccoli sprout extracts in the treatment of advanced PDA. The study objectives will provide data on the clinical feasibility and acceptability of a supportive treatment option accompanying palliative chemotherapy. Based on these results, future clinical studies to create further evidence in this field are possible.
Trial registration
The POUDER trial has been registered at ClinicalTrials.gov with an ID NCT01879878 and WHO with an ID U1111-1144-2013 on June 13th 2013.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial (CC BY).
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