Purified dry extract of Paullinia cupana (guaraná) (PC-18) for chemotherapy-related fatigue in patients with solid tumors: An early discontinuation study.

Abstract

e20680 Background: Paullinia cupana (guaraná) is an Amazonian plant that has been previously shown to be effective in treating chemotherapy-related fatigue (CRF) in patients with breast cancer. We aimed to evaluate the efficacy of a purified dry extract of P. cupana (PC-18) in patients with various solid tumors treated with chemotherapy. Methods: We included 40 patients with solid tumors who showed increases in their Brief Fatigue Inventory (BFI) questionnaire scores after one week of systemic chemotherapy. PC-18 was administered at 37.5 mg by mouth two times per day (PO bid), starting after one week of chemotherapy, for three weeks (induction phase). Patients who had an improvement in or stabilization of their BFI scores were randomized to receive either PC-18 at the same dose or placebo for the following three weeks (maintenance phase). Results: After PC-18 treatment, the BFI fatigue scores improved or stabilized in 36 out of the 40 patients (mean BFI score difference = 2.503; 95% CI: 1.716 – 3.375, P = 0.0002). Three weeks after randomization (16 patients on PC-18 and 17 on placebo), we observed no significant differences in the BFI, FACIT, HADS, and PSQI scores between patients randomized to PC-18 versus placebo. Conclusions: We conclude that the PC-18 extract is effective for the treatment of CRF in patients with a variety of solid tumors. A conditioning effect, which was observed in patients with early positive effects of PC-18 on CRF, may explain the better than expected fatigue scores of the placebo-treated patients.

Placebo response in trials of drug treatments for cancer-related fatigue: a systematic review, meta-analysis and meta-regression

“…In further exploration at data extraction, seven more studies were rejected for one or more of the reasons listed above. The final number of trials included for qualitative analysis was 30 22–51 (figure 1). In 11 trials, some of the data needed for meta-analysis were not published in the trial paper; therefore, we sought contact with authors.…”

Cancer-related fatigue: ESMO Clinical Practice Guidelines for diagnosis and treatment

“…The first one in patients with breast cancer undergoing ChT showed an improvement in CRF 72 ; the second one in patients with various solid tumours treated with ChT showed no difference compared with placebo. 73 Mistletoe was administrated as an aqueous extract in 352 breast cancer patients during ChT with cyclophosphamide, methotrexate and fluorouracil (CMF). The results showed an improvement in QoL, fatigue and other symptoms for mistletoe compared with placebo.…”

Screening, evaluation, and management of cancer‐related fatigue: Ready for implementation to practice?

“…253 In a large, rigorously conducted, double-blind, placebocontrolled trial in cancer survivors, Wisconsin ginseng (an 8-week course of 2000 mg daily) improved fatigue outcomes and was well tolerated. 254 However, inconsistent effects on fatigue outcomes have been observed in studies of other nutritional supplements and herbal remedies, including vitamin supplements, 255-258 multicomponent nutritional supplementation, [259][260][261] coenzyme Q10, 262 levocarnitine, [263][264][265][266][267][268][269] lectin-standardized mistletoe, 270 omega-3 fatty acid supplements in combination with megestrol acetate, 271 protein supplementation in combination with nutritional counseling, 272 gaurana, [273][274][275] Chinese herbal medicine, 276 essiac, 277 and valerian. 278 There is preliminary evidence that expressive writing [279][280][281][282] ; art, music, dance, or animal-assisted therapy [283][284][285][286][287][288][289][290] ; exposure to nature and green space 291 ; moxibustion 227,292 ; distraction-virtual reality immersion [293][294][295][296]…”

“…In a large, rigorously conducted, double‐blind, placebo‐controlled trial in cancer survivors, Wisconsin ginseng (an 8‐week course of 2000 mg daily) improved fatigue outcomes and was well tolerated . However, inconsistent effects on fatigue outcomes have been observed in studies of other nutritional supplements and herbal remedies, including vitamin supplements, multicomponent nutritional supplementation, coenzyme Q10, levocarnitine, lectin‐standardized mistletoe, omega‐3 fatty acid supplements in combination with megestrol acetate, protein supplementation in combination with nutritional counseling, gaurana, Chinese herbal medicine, essiac, and valerian …”