Broccoli sprout supplementation in patients with advanced pancreatic cancer is difficult despite positive effects—results from the POUDER pilot study

• Published in: Investigational new drugs Vol. 38; no. 3; pp. 776 - 784
• Main Authors: Lozanovski, Vladimir J., Polychronidis, Georgios, Gross, Wolfgang, Gharabaghi, Negin, Mehrabi, Arianeb, Hackert, Thilo, Schemmer, Peter, Herr, Ingrid
• Format: Journal Article
• Language: English
• Published: New York Springer US 01.06.2020; Springer Nature B.V
• Subjects: Adenocarcinoma; Aged; Biological Products - therapeutic use; Brassica - chemistry; Broccoli; Carcinoma, Pancreatic Ductal; Chemotherapy; Dietary Supplements; Drug development; Epidemiology; Feasibility studies; Female; Glucosinolates - therapeutic use; Humans; Isothiocyanates - therapeutic use; Male; Malignancy; Medicine; Medicine & Public Health; Methylcellulose; Middle Aged; Nausea; Oncology; Oximes - therapeutic use; Pancreatic cancer; Pancreatic Neoplasms; Pancreatic Neoplasms - drug therapy; Patients; Pharmacology/Toxicology; Phase I Studies; Pilot Projects; Prospective Studies; Statistical analysis; Sulforaphane; Sulfoxides - therapeutic use; Supplements; Survival; Survival Rate; Vegetables; Vomiting; Clinical trial; POUDER trial [NCT01879878]; Broccoli sprouts; Sulforaphane; Pancreatic cancer
• ISSN: 0167-6997; 1573-0646
• DOI: 10.1007/s10637-019-00826-z

Summary Pancreatic ductal adenocarcinoma is a highly aggressive malignancy with short survival and limited therapeutic options. Broccoli sulforaphane is a promising new treatment due to the results of recent epidemiological, experimental and patient studies. Upon approval from the ethics committee and registration at ClinicalTrials.gov , 40 patients with palliative chemotherapy were placed into a placebo and treatment group in an unblinded fashion. Fifteen capsules with pulverized broccoli sprouts containing 90 mg/508 μmol sulforaphane and 180 mg/411 μmol glucoraphanin or methylcellulose were administered daily for up to 1 year. Twenty-nine patients were included in the treatment group and 11 patients were in the placebo group; these patients were followed for up to 1 year. The patient characteristics, overall survival and feasibility were assessed. Compared to those of the placebo group, the mean death rate was lower in the treatment group during the first 6 months after intake (day 30: 0%/18%, day 90: 0%/25%, and day 180: 25%/43%), and Kaplan-Meier analysis revealed a higher survival rate. There was a high drop-out rate (72% in the treatment group and 55% in the placebo group) after 1 year. We concluded from the Karnofsky index that the broccoli sprouts did not impact patient’s self-care and overall abilities severely. The intake of 15 capsules daily was difficult for some patients, and the broccoli sprouts sometimes increased digestive problems, nausea and emesis. We did not obtain statistically significant results ( p  = 0.291 for the endpoint at day 180), but the knowledge about the feasibility is the basis for the development of new sulforaphane drugs.