دورية أكاديمية
أعرض في EDS

Purified Dry Paullinia cupana (PC-18) Extract for Chemotherapy-Induced Fatigue: Results of Two Double-Blind Randomized Clinical Trials.

التفاصيل البيبلوغرافية
العنوان: Purified Dry Paullinia cupana (PC-18) Extract for Chemotherapy-Induced Fatigue: Results of Two Double-Blind Randomized Clinical Trials.
المؤلفون: Sette CVM; a Oncology Department , ABC Medical School , Santo Andre , Brazil., Ribas de Alcântara BB; a Oncology Department , ABC Medical School , Santo Andre , Brazil., Schoueri JHM; b ABC Medical School , Santo Andre , Brazil., Cruz FM; a Oncology Department , ABC Medical School , Santo Andre , Brazil., Cubero DIG; a Oncology Department , ABC Medical School , Santo Andre , Brazil., Pianowski LF; c Kyolab Laboratório Ltda , Valinhos , Brazil., Peppone LJ; d University of Rochester , Rochester , NY , USA., Fonseca F; b ABC Medical School , Santo Andre , Brazil., Del Giglio A; a Oncology Department , ABC Medical School , Santo Andre , Brazil.
المصدر: Journal of dietary supplements [J Diet Suppl] 2018 Sep 03; Vol. 15 (5), pp. 673-683. Date of Electronic Publication: 2017 Nov 30.
نوع المنشور: Journal Article; Randomized Controlled Trial
اللغة: English
بيانات الدورية: Publisher: Informa Healthcare Country of Publication: England NLM ID: 101249830 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1939-022X (Electronic) Linking ISSN: 19390211 NLM ISO Abbreviation: J Diet Suppl Subsets: MEDLINE
أسماء مطبوعة: Publication: London : Informa Healthcare
Original Publication: New York, NY : Informa Healthcare
مواضيع طبية MeSH: Paullinia* , Phytotherapy*, Antineoplastic Agents/*adverse effects , Fatigue/*drug therapy , Plant Extracts/*therapeutic use, Breast Neoplasms/drug therapy ; Double-Blind Method ; Fatigue/chemically induced ; Female ; Humans ; Magnesium/administration & dosage ; Magnesium/blood ; Middle Aged ; Placebos ; Seeds/chemistry ; Surveys and Questionnaires
مستخلص: Fatigue is frequent among oncologic patients. Unpurified Paullinia cupana dry extract showed encouraging results for chemotherapy-induced fatigue in our previous studies. We report two randomized, double-blind studies with a standardized dry purified Paullinia cupana extract named PC-18. For both studies, we recruited early breast cancer patients who had an increase in their fatigue scores after their first cycle of adjuvant chemotherapy. In the first study, we compared an oral dose of 37.5 mg of PC-18 twice daily with placebo. In the second study, we examined PC-18 at either 7.5 or 12.5 mg orally twice daily versus placebo. In both studies, PC-18 was not superior to placebo as assessed by both Chalder and Brief Fatigue Inventory (BFI) fatigue questionnaires, probably reflecting unexpectedly good placebo antifatigue activity. Since all capsules employed in both studies contained about 100 mg of magnesium silicate as an excipient, we retrospectively evaluated frozen serum samples from the second study and found a significant increase in magnesium levels after patients received placebo. By multivariate analysis, higher prerandomization magnesium levels and higher BFI scores together with the use of a 12.5 mg dose of PC-18 all correlated significantly with higher posttreatment BFI scores. We observed no significant toxicities in any of the trials. We conclude that the absence of differences between PC-18 and placebo may be due to the unexpectedly high antifatigue activity of the placebo in these studies. Further studies evaluating the role of magnesium supplementation for chemotherapy-induced fatigue are needed.
فهرسة مساهمة: Keywords: Paullinia cupana; breast cancer; chemotherapy-induced fatigue; randomized control trial
المشرفين على المادة: 0 (Antineoplastic Agents)
0 (Placebos)
0 (Plant Extracts)
I38ZP9992A (Magnesium)
تواريخ الأحداث: Date Created: 20171201 Date Completed: 20181105 Latest Revision: 20181105
رمز التحديث: 20231215
DOI: 10.1080/19390211.2017.1384781
PMID: 29190155
قاعدة البيانات: MEDLINE
الوصف
تدمد:1939-022X
DOI:10.1080/19390211.2017.1384781