Exploring the Safety, Effectiveness, and Cost-Effectiveness of a Chinese Patent Medicine (Fufang E’jiao Syrup) for Alleviating Cancer-Related Fatigue: A Protocol for a Randomized, Double-Blinded, Placebo-Controlled, Multicenter Trial

Objective: To provide higher level evidence on the benefits of a Chinese patent medicine (CPM) (Fufang E’jiao Syrup, FFEJS) for alleviating cancer-related fatigue (CRF), this article describes a protocol for a randomized controlled trial. Methods/design: We designed a double-blind, placebo-controlled stratified permuted block randomization clinical trial on CRF among 3 types of cancer in China. Participants will be equally allocated to FFEJS group or placebo group according to the randomization sequence and the hospitals they were enrolled at. Each patient will receive 20 ml of either the study formula FFEJS or a placebo formula, 3 times a day for 6 weeks. The follow-up period will be another 4 weeks for safety evaluation. The primary outcome is the difference in improvement of fatigue as measured with the Revised Piper Fatigue Scale-Chinese Version (RPFS-CV). Secondary outcomes include change in fatigue (measured by routine blood panel and hormones in peripheral blood) and QoL (measured by Edmonton symptom assessment scale and Functional Assessment of Cancer Therapy). Patient safety will be measured by liver, renal or cardiac damage, and the risk of FFEJS having a tumor promotion and progression effect will be monitored throughout this study. Cost-effectiveness will also be evaluated mainly by incremental cost per each quality-adjusted life year gained. Discussion: This article describes the study design of a CPM for CRF in patients with advanced cancer through exploring the effectiveness, safety, and cost-effectiveness of FFEJS. Trial registration: ClinicalTrials.gov, NCT04147312. Registered on 1 Sep 2019.

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Dexamethasone (DM) for cancer-related fatigue: A double-blinded, randomized, placebo-controlled trial.

Journal of Clinical Oncology ◽

10.1200/jco.2012.30.15_suppl.9002 ◽

2012 ◽

Vol 30 (15_suppl) ◽

pp. 9002-9002 ◽

Cited By ~ 6

Author(s):

Sriram Yennurajalingam ◽

Susan Frisbee-Hume ◽

Marvin Omar Delgado-Guay ◽

Janet Bull ◽

Alexandria T. Phan ◽

...

Keyword(s):

Advanced Cancer ◽

Controlled Trial ◽

Symptom Assessment ◽

Primary Objective ◽

Controlled Study ◽

Advanced Cancer Patients ◽

Double Blind ◽

Cancer Related Fatigue ◽

Significant Difference ◽

Edmonton Symptom Assessment Scale

9002 Background: Cancer-related-fatigue (CRF) is the most common and distressing symptoms in patients with advanced cancer. Currently, there is no standard treatment for CRF. Although corticosteroids have been used in the treatment of CRF, there are no well-powered placebo-controlled trials that used a validated CRF outcome measure. The primary objective of this prospective, randomized, double-blind, placebo-controlled study is to compare the effect of DM versus placebo on CRF. Methods: Advanced cancer patients with fatigue ≥ 4/10 on the Edmonton Symptom Assessment Scale (ESAS) and at least 2 other CRF-related symptoms (pain, nausea, appetite, depression, anxiety or sleep disturbance ≥ 4/10), normal cognition, no infections and hemoglobin ≥ 9 g/L were eligible for enrollment. Patients were randomized to either receive dexamethasone 4 mg orally twice a day for 15 days (primary end point) or matching placebo. The primary outcome was the day 15 change in Functional Assessment of Chronic Illness-Fatigue (FACIT-F) subscale scores. Differences in the group means (normal distribution) were analyzed using the two-sample t-test. Results: In 83 evaluable patients (43 DM and 40 placebo), median age was 60 years, 61% were white, and 53% were female. There was no difference in the demographics and fatigue (FACIT-F subscale) between DM and placebo groups except for sex (p=0.02). The mean (SD) FACIT-F subscores at baseline and at day 15 for DM were 18 (11) and 27 (11) (p<0.001) and for placebo were 21 (9) and 24 (12) (p=0.06), respectively. Mean improvement in FACIT-F subscale was significantly higher in the DM group compared to placebo (9.6 (11) vs. 3.1 (9.7), p=0.005). We found a significant difference in ESAS physical distress (p=0.02), but no differences in ESAS overall symptom distress (p=0.11) and ESAS psychological distress (P=0.88) between DM and placebo. There were insignificantly higher numbers of grade ≥3 toxicities in patients who received DM than in patients who received placebo (20/42 vs. 18/47, p=0.37). Conclusions: Dexamethasone was more effective than placebo in reducing CRF in patients with advanced cancer. Long-term safety studies are needed.

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Traditional Chinese patent medicine for prophylactic treatment of migraine: a meta-analysis of randomized, double-blind, placebo-controlled trials

European Journal of Neurology ◽

10.1111/ene.12581 ◽

2014 ◽

Vol 22 (2) ◽

pp. 361-368 ◽

Cited By ~ 9

Author(s):

Y. Xiao ◽

L. Yuan ◽

Y. Liu ◽

X. Sun ◽

J. Cheng ◽

...

Keyword(s):

Prophylactic Treatment ◽

Meta Analysis ◽

Controlled Trials ◽

Double Blind ◽

Double Blind Placebo ◽

Chinese Patent Medicine ◽

Chinese Patent ◽

Traditional Chinese Patent Medicine ◽

Patent Medicine

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Effects of high-dose Asian ginseng (Panax ginseng) to improve cancer-related fatigue: Results of a double-blind, placebo-controlled randomized controlled trial.

Journal of Clinical Oncology ◽

10.1200/jco.2016.34.26_suppl.209 ◽

2016 ◽

Vol 34 (26_suppl) ◽

pp. 209-209 ◽

Cited By ~ 1

Author(s):

Sriram Yennu ◽

Nizar M. Tannir ◽

Janet L. Williams ◽

Kenneth R. Hess ◽

Susan Frisbee-Hume ◽

...

Keyword(s):

Functional Assessment ◽

Controlled Trial ◽

Depression Scale ◽

Primary Objective ◽

High Dose ◽

Cancer Type ◽

Double Blind ◽

Ginseng Extract ◽

Cancer Related Fatigue ◽

Edmonton Symptom Assessment Scale

209 Background: Cancer related fatigue (CRF) is the most common and disabling symptom in cancer.Panax ginseng extract (PG) is frequently used as a nutraceutical treatment for fatigue. There are no well-powered placebo-controlled trials that used validated CRF outcome measures to investigate of PG effects in cancer patients. The primary objective of this trial was to evaluate the effects oral PG versus Placebo (PL) for CRF. Methods: Patients with cancer fatigue ≥ 4/10 on Edmonton Symptom Assessment Scale (ESAS) were eligible. Patients were randomized to either 400mg of standardized PG or matching PL orally twice a day for 28 days. The primary endpoint was change in the Functional Assessment of Chronic Illness-Fatigue (FACIT-F) fatigue subscale from baseline to Day 28. Secondary outcomes were Functional Assessment of Cancer Therapy-General (FACT-G), Hospital Anxiety and Depression Scale (HADS), and ESAS. Results: Total evaluable patients were 112 (56 for PG and PL groups). No significant differences in baseline characteristics between the two groups except cancer type (p = 0.002). There was significant improvement in FACIT fatigue and ESAS fatigue scores in PG and PL groups at Day 15 and Day 29. The mean (SD) of FACIT-F fatigue scores at baseline, Day 15, and Day 29 were 22.6 (10.4), 29.8(10.7), 30.1 (11.6) and 23.8 (9.1), 30.0 (10.1), 30.4 (11.6) for PG and PL respectively. Mean (SD) improvement in the FACIT-F subscale at Day 29 was not significantly different in PG than in the PL group [7.5 (12.7) vs 6.5 (9.9), P = 0.67]. Mean (SD) improvement in the ESAS fatigue, FACT-G, and HADS at Day 29 were also not significantly different in PG than in the PL group. In a multiple linear model analysis, the change in FACIT-F fatigue from Day 0 to Day 29 was negatively correlated with baseline FACIT-F fatigue (p = 0.0005), baseline HADS score (p = 0.032), and male gender (p = 0.023). There were a significantly higher number of any grade of toxicities in PL group than in PG group (33/62 vs. 28/64, p = 0.024). Conclusions: Both PG and Placebo result in a significant improvement in CRF at Day 15 and Day 29. PG was not significantly superior to placebo after 4 weeks of treatment. Further studies are needed. Clinical trial information: NCT01375114.

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