A pilot, multi-dose, placebo-controlled evaluation of american ginseng (panax quinquefolius) to improve cancer-related fatigue: NCCTG trial N03CA

9001 Background: Fatigue is one of the most common symptoms in people diagnosed with cancer. Ginseng is a popular herb for treatment of this. It has been termed an “adaptogen”, felt to be able to restore balance to the body; its potential anti-fatigue efficacy is supported by animal data. The purpose of this pilot trial was to evaluate three doses of American Ginseng versus placebo for cancer-related fatigue. Methods: Patients with a life expectancy = 6 months and a history of cancer-related fatigue who had been experiencing fatigue = 1 month were eligible. Exclusion criteria included prior use of ginseng, chronic systemic steroids and brain malignancies. Other etiologies for fatigue, such as pain, were also excluded. Participants were randomized to receive, in a double blind manner, placebo, 750 mg/d, 1,000 mg/d or 2,000 mg/d of American Ginseng in BID dosing for 8 weeks. Endpoints included The Brief Fatigue Inventory (BFI), the Vitality Subscale of the SF-36 and several numeric analogue questions of perceived benefit; endpoints were measured at baseline, 4 weeks and 8 weeks. Area under the curve (AUC) and change from baseline were calculated. Results: Two hundred eighty two patients (69–72 per arm) were enrolled from 10/21/2005 to 07/05/2006. Available 8-week data are provided in the table below; higher numbers are better. There were no statistically significant differences in any grade of toxicity between active and placebo arms, and an equivalent number of patients discontinued the study due to adverse events in each arm. Conclusion: This randomized pilot trial provided data to suggest that American Ginseng doses of 1000–2000 mg/d may be effective for alleviating cancer related fatigue. Therefore, further study of American Ginseng in cancer survivors appears warranted. No significant financial relationships to disclose. [Table: see text]

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Phase III evaluation of American ginseng (panax quinquefolius) to improve cancer-related fatigue: NCCTG trial N07C2.

Journal of Clinical Oncology ◽

10.1200/jco.2012.30.15_suppl.9001 ◽

2012 ◽

Vol 30 (15_suppl) ◽

pp. 9001-9001 ◽

Cited By ~ 3

Author(s):

Debra L. Barton ◽

Heshan Liu ◽

Shaker R. Dakhil ◽

Breanna M. Linquist ◽

Jeff A. Sloan ◽

...

Keyword(s):

Side Effects ◽

American Ginseng ◽

The Body ◽

Phase Iii ◽

Cns Lymphoma ◽

Negative Effects ◽

Double Blind ◽

Curative Intent ◽

Patients With Cancer ◽

Cancer Related Fatigue

9001 Background: Ginseng is popularly used as a treatment for fatigue, one of the most common and disabling symptoms in people diagnosed with cancer. It is termed an “adaptogen”, thought to help the body combat negative effects of stress. This trial was to evaluate 2,000 mg American Ginseng versus placebo for cancer-related fatigue (CRF). Methods: Patients with cancer undergoing or having completed curative intent treatment and experiencing fatigue, rated at least 4 on a numeric analogue fatigue scale (1-10) for ≥1 month, were eligible. Exclusion criteria included CNS lymphoma, brain malignancies, or prior use of ginseng or chronic systemic steroids. Other etiologies for fatigue, such as pain and sleep, were also excluded. Patients were randomized to receive, in a double blind manner, 2,000 mg/d of American Ginseng or placebo in BID dosing for 8 weeks. The primary endpoint was change from baseline in the general subscale of the Multidimensional Fatigue Symptom Inventory (MFSI) at 4 weeks. Other MFSI subscales and the fatigue-inertia subscale of the Profile of Mood States (POMS) were also analyzed. Data were transformed to a 0-100 scale. Results: 364 patients were enrolled from 10/2008 to 07/2011. Data at 4 and 8 weeks are provided for several fatigue endpoints in the table below; higher numbers are better. Mental, emotional and vigor subscales of the MFSI were not significantly different between arms. There were no statistically significant differences in any grade of toxicity or self reported side effects between ginseng and placebo. Conclusions: This trial provides data to support that American Ginseng reduces general and physical CRF over 8 weeks without side effects. The treatment did not provide significant reductions in fatigue at 4 weeks and did not impact mental, emotional, and vigor dimensions of fatigue. [Table: see text]

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Single Ingestion of Trehalose Enhances Prolonged Exercise Performance by Effective Use of Glucose and Lipid in Healthy Men

Nutrients ◽

10.3390/nu13051439 ◽

2021 ◽

Vol 13 (5) ◽

pp. 1439

Author(s):

Naomi Hamada ◽

Tsuyoshi Wadazumi ◽

Yoko Hirata ◽

Mayumi Kuriyama ◽

Kanji Watanabe ◽

...

Keyword(s):

Exercise Performance ◽

Prolonged Exercise ◽

Insulin Response ◽

Area Under The Curve ◽

Constant Load ◽

Bicycle Ergometer ◽

The Body ◽

Water Control ◽

Double Blind ◽

Healthy Men

Trehalose increases blood glucose levels slowly and induces a slight insulin response. The present study aimed to study the effect of trehalose on prolonged exercise performance. The participants were 12 healthy men (age: 21.3 ± 0.9 y). After an overnight fast (12 h), they first exercised with a constant load (intensity: 40% V˙O2peak) for 60 min using a bicycle ergometer. They continued to exercise with a constant load (40% V˙O2peak) for 30 min between four sets of the 30-s Wingate test. After the 1st set, each participant ingested 500 mL water (control), 8% glucose, or 8% trehalose in three trials. These three trials were at least one week apart and were conducted in a double-blind and randomized crossover manner. Blood was collected for seven biochemical parameters at 12 time points during the experiment. The area under the curve of adrenaline after ingestion of trehalose was significantly lower than that for water and tended to be lower than that for glucose in the later stage of the exercise. Lower secretion of adrenaline after a single dose of 8% trehalose during prolonged exercise reflected the preservation of carbohydrates in the body in the later stage of the exercise. In conclusion, a single ingestion of trehalose helped to maintain prolonged exercise performance.

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A randomized, double blind, placebo-controlled crossover trial of a sustained release methylphenidate in cancer-related fatigue.

Journal of Clinical Oncology ◽

10.1200/jco.2012.30.15_suppl.9072 ◽

2012 ◽

Vol 30 (15_suppl) ◽

pp. 9072-9072

Author(s):

Carmelita P. Escalante ◽

Christina A. Meyers ◽

James M. Reuben ◽

Xuemei Wang ◽

Wei Qiao ◽

...

Keyword(s):

Verbal Learning ◽

Female Breast Cancer ◽

Categorical Variables ◽

Serious Adverse Events ◽

Double Blind ◽

Cancer Related Fatigue ◽

Signed Rank ◽

Brief Fatigue Inventory ◽

The Mean ◽

Learning Test

9072 Background: Cancer-related fatigue (CRF) is common and distressing. This study assessed the efficacy of OROS methylphenidate 18 mg daily (OM) vs. placebo (P) for CRF reduction. Other objectives were to compare the effects of OM vs. P on other symptoms, cognitive function, work yield, patient (pt) perceptions and preferences, and an exploratory analysis of cytokines. Methods: Initially, pts were randomly assigned (1:1) to receive OM-P or P-OM for 4 weeks (wks). Pts were crossed to the other treatment after 2 wks. Assessments were done at baseline, 2 and 4 wks. Continuous and categorical variables were assessed using Wilcoxon signed rank tests and McNemar tests, respectively. The primary efficacy end point was the change of “fatigue worst” on the Brief Fatigue Inventory (BFI) at the end of each 2 wk period. Results: 42 female breast cancer pts were enrolled (3 ineligible, 6 unevaluable); 33 pts were studied. The mean age was 58 (range, 32-79), 30% had metastasis, 82% were receiving chemotherapy (ctx), 9% hormonal therapy (ht), and 9% both ctx and ht. 94% were ECOG <1 and 52% were employed. 45% were on pain medicines and none on antidepressants. The mean baseline BFI was 5.7 (range 4.1-8.6). Fatigue worst did not differ between OM and P (p= 0.54) or in other symptoms. There was significance in WAIS-III Digit Symbol between OM and P (p=0.01), and Hopkins Verbal Learning Test with BFI interfere and BFI active (p=0.04, p=0.03, respectively). Hours (hrs) missed due to health (p=0.03) and hrs worked (p=0.04) differed in OM vs. P. At study end, pts were asked if OM improved CRF and if they wanted to stay on OM. 64% felt improved. Of these, 58% wanted to continue. There were no serious adverse events due to OM. There were differences in serum IL6 (p=0.03), IL10 (p=0.0004), and TNFα (p=0.02) among OM and P. Conclusions: Low dose OM did not show improvement in CRF on fatigue worst of BFI. Pts taking OM had better cognition and less work absences. Pts tolerated OM well and a majority felt better and wanted to continue OM. Future studies examining higher doses or longer treatment duration with OM, pt preferences and impact on productivity are necessary. Changes in serum cytokine levels should be further explored.

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Absorption Kinetics of Berberine and Dihydroberberine and Their Impact on Glycemia: A Randomized, Controlled, Crossover Pilot Trial

Nutrients ◽

10.3390/nu14010124 ◽

2021 ◽

Vol 14 (1) ◽

pp. 124

Author(s):

Jessica M. Moon ◽

Kayla M. Ratliff ◽

Anthony M. Hagele ◽

Richard A. Stecker ◽

Petey W. Mumford ◽

...

Keyword(s):

Standardized Test ◽

Venous Blood ◽

Pilot Trial ◽

Area Under The Curve ◽

Preliminary Evidence ◽

Crossover Fashion ◽

Double Blind ◽

Fourth Dose ◽

Study Participants ◽

The Impact

Berberine is a natural alkaloid used to improve glycemia but displays poor bioavailability and increased rates of gastrointestinal distress at higher doses. Recently, dihydroberberine has been developed to combat these challenges. This study was designed to determine the rate and extent to which berberine appeared in human plasma after oral ingestion of a 500 mg dose of berberine (B500) or 100 mg and 200 mg doses of dihydroberberine (D100 and D200). In a randomized, double-blind, crossover fashion, five males (26 ± 2.6 years; 184.2 ± 11.6 cm; 91.8 ± 10.1 kg; 17.1 ± 3.5% fat) completed a four-dose supplementation protocol of placebo (PLA), B500, D100, and D200. The day prior to their scheduled visit, participants ingested three separate doses with breakfast, lunch, and dinner. Participants fasted overnight (8–10 h) and consumed their fourth dose with a standardized test meal (30 g glucose solution, 3 slices white bread) after arrival. Venous blood samples were collected 0, 20, 40, 60, 90, and 120 minutes (min) after ingestion and analyzed for BBR, glucose, and insulin. Peak concentration (CMax) and area under the curve (AUC) were calculated for all variables. Baseline berberine levels were different between groups (p = 0.006), with pairwise comparisons indicating that baseline levels of PLA and B500 were different than D100. Berberine CMax tended to be different (p = 0.06) between all conditions. Specifically, the observed CMax for D100 (3.76 ± 1.4 ng/mL) was different than PLA (0.22 ± 0.18 ng/mL, p = 0.005) and B500 (0.4 ± 0.17 ng/mL, p = 0.005). CMax for D200 (12.0 ± 10.1 ng/mL) tended (p = 0.06) to be different than B500. No difference in CMax was found between D100 and D200 (p = 0.11). Significant differences in berberine AUC were found between D100 (284.4 ± 115.9 ng/mL × 120 min) and PLA (20.2 ± 16.2 ng/mL × 120 min, p = 0.007) and between D100 and B500 (42.3 ± 17.6 ng/mL × 120 min, p = 0.04). Significant differences in D100 BBR AUC (284.4 ± 115.9 ng/mL×120 min) were found between PLA (20.2 ± 16.2 ng/mL × 120 min, p = 0.042) and B500 (42.3 ± 17.6 ng/mL × 120 min, p = 0.045). Berberine AUC values between D100 and D200 tended (p = 0.073) to be different. No significant differences in the levels of glucose (p = 0.97) and insulin (p = 0.24) were observed across the study protocol. These results provide preliminary evidence that four doses of a 100 mg dose of dihydroberberine and 200 mg dose of dihydroberberine produce significantly greater concentrations of plasma berberine across of two-hour measurement window when compared to a 500 mg dose of berberine or a placebo. The lack of observed changes in glucose and insulin were likely due to the short duration of supplementation and insulin responsive nature of study participants. Follow-up efficacy studies on glucose and insulin changes should be completed to assess the impact of berberine and dihydroberberine supplementation in overweight, glucose intolerant populations.

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Sipjeondaebo-tang in patients with breast cancer with fatigue: a protocol for a pilot, randomised, double-blind, placebo-controlled, cross-over trial

BMJ Open ◽

10.1136/bmjopen-2017-021242 ◽

2018 ◽

Vol 8 (7) ◽

pp. e021242 ◽

Cited By ~ 6

Author(s):

Chunhoo Cheon ◽

Sohyeon Kang ◽

Youme Ko ◽

Mia Kim ◽

Bo-Hyoung Jang ◽

...

Keyword(s):

Breast Cancer ◽

Outcome Measurement ◽

Secondary Outcome ◽

Scientific Conference ◽

Double Blind ◽

European Organization ◽

Double Blind Placebo ◽

Cancer Related Fatigue ◽

Institutional Review ◽

Brief Fatigue Inventory

IntroductionCancer-related fatigue is a frequent symptom in patients with cancer and one of the most distressing symptoms in patients with breast cancer. Sipjeondaebo-tang (Juzen-taiho-to in Japanese or Shi-Quan-Da-Bu-Tang in Chinese) is a widely used herbal medicine for the treatment of fatigue in Korea, China and Japan. The purpose of the present study is to evaluate the feasibility of Sipjeondaebo-tang for cancer-related fatigue.Methods and analysisThe present study is a randomised, double-blind, placebo-controlled, cross-over study. Forty-eight patients with breast cancer who are indicated for doxorubicin and cyclophosphamide will be recruited. The participants will receive 3 g of Sipjeondaebo-tang or a placebo three times a day for 56 days. The primary outcome measurement is the change in the Brief Fatigue Inventory scores. The secondary outcome measurements include the changes in the Visual Analogue Scale (VAS) of fatigue, and quality of life measured by the European Organization for Research and Treatment of Cancer—QLQ-C30 and QLQ-BR23. VAS of fatigue will be measured on every visit, and other outcomes will be measured on visits 2, 4, 6 and 7. The total study period is 14 weeks.Ethics and disseminationThis study has been approved by the Institutional Review Board of the Catholic Kwandong University International St Mary’s Hospital (reference IS16MNSI0011). The results of this study will be published in a peer-reviewed journal and presented at a scientific conference.Trial registration numberNCT02858856; Pre-results.

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A Randomized, Double-Blind, Controlled Clinical Study on the Curative Effect of Huaier on Mild-to-Moderate Psoriasis and an Experimental Study on the Proliferation of Hacat Cells

BioMed Research International ◽

10.1155/2018/2372895 ◽

2018 ◽

Vol 2018 ◽

pp. 1-9 ◽

Cited By ~ 4

Author(s):

Dongqiang Su ◽

Xuening Zhang ◽

Likun Zhang ◽

Jin Zhou ◽

Feng Zhang

Keyword(s):

Cell Cycle ◽

Cell Proliferation ◽

Life Quality ◽

The Body ◽

Control Group ◽

Hacat Cells ◽

Antitumor Effects ◽

Double Blind ◽

Keratinocyte Proliferation ◽

Number Of Patients

The antitumor effects of Huaier have been recently revealed. However, no research has been conducted on the effects of Huaier on keratinocyte proliferation and for the treatment of psoriasis. Hacat cells were treated with different concentrations of Huaier for different periods of times. The effects on cell proliferation and vitality and on the cell cycle were detected. Patients with mild-to-moderate psoriasis were randomized and divided into two groups in a double-blind manner. The experimental group was given sugar-free Yinxie granules and Huaiqihuang (HQH) granules, and the control group was given sugar-free Yinxie granules and placebo. After 4 weeks, various therapeutic indexes were compared. Huaier significantly inhibited Hacat cell proliferation, suppressed vitality, and blocked the cell cycle in the G1 phase compared with the control group (P < 0.01, respectively). After treatment for 4 weeks, the number of patients between the two groups that experienced a 50% reduction in the Psoriasis Area and Severity Index (PASI 50), PASI 75 and PASI 90, was significantly different (P <0.01). The body surface area (BSA) affected by psoriasis and static physician’s global assessment (sPGA) was significantly reduced (P < 0.01); additionally, a significant improvement in the Dermatology Life Quality Index (DLQI) (P < 0.01) was observed. Huaier has shown promising effects in both clinical and experimental setting in this preliminary study and it might provide some benefit in the treatment of psoriasis vulgaris in the future.

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Acupuncture for cancer-related fatigue in lung cancer patients: a randomized, double blind, placebo-controlled pilot trial

Supportive Care in Cancer ◽

10.1007/s00520-017-3812-7 ◽

2017 ◽

Vol 25 (12) ◽

pp. 3807-3814 ◽

Cited By ~ 14

Author(s):

Chien-shan Cheng ◽

Lian-yu Chen ◽

Zhou-yu Ning ◽

Chen-yue Zhang ◽

Hao Chen ◽

...

Keyword(s):

Lung Cancer ◽

Cancer Patients ◽

Pilot Trial ◽

Double Blind ◽

Double Blind Placebo ◽

Lung Cancer Patients ◽

Cancer Related Fatigue

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A Double-blind, Placebo-controlled Evaluation of the Effects of RW94 on the Body Weight of Both Overweight and Obese Healthy Volunteers

Current Medical Research and Opinion ◽

10.1185/03007999809113365 ◽

1998 ◽

Vol 14 (4) ◽

pp. 243-249 ◽

Cited By ~ 5

Author(s):

A. R. Williams

Keyword(s):

Body Weight ◽

Healthy Volunteers ◽

The Body ◽

Double Blind ◽

Double Blind Placebo ◽

Controlled Evaluation

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Safety and Efficacy of Injectable Pentigetide: Double-Blind, Placebo-Controlled Study in Patients with Allergic Rhinitis

American Journal of Rhinology ◽

10.2500/105065889782009651 ◽

1989 ◽

Vol 3 (3) ◽

pp. 155-161

Author(s):

Bruce M. Prenner ◽

Kathryn F. Rangus ◽

Michael A. Eldon

Keyword(s):

Allergic Rhinitis ◽

Controlled Trial ◽

Pilot Trial ◽

Placebo Treatment ◽

Controlled Study ◽

Double Blind ◽

Safety And Efficacy ◽

Double Blind Placebo ◽

Number Of Patients ◽

Study Completion

Pentigetide is a synthetic pentapeptide derived from the Fc region of human IgE reported to inhibit IgE-mediated allergic responses. A randomized, double-blind, placebo-controlled trial was conducted to evaluate the safety and efficacy of subcutaneously administered pentigetide in the treatment of allergic rhinitis. After a 3-day baseline period, 55 patients received 5 injections of either 20 mg of pentigetide for injection (n = 31) or placebo solution (n = 24), one injection every 3 to 4 days for 14 days. Physician assessment of frequency and severity of sneezing, rhinorrhea, congestion, nasal itching, and 3 non-nasal symptoms obtained at baseline, after 1 week, and study completion were compared between pentigetide and placebo treatment groups. The physician's assessment of therapeutic response made at study completion showed that 71% of patients receiving pentigetide were improved, whereas 37% of patients receiving placebo had improved, a difference which was statistically (chi square, p = 0.013) as well as clinically significant. Mean symptom scores indicated that the frequency and severity of sneezing, rhinorrhea, and nasal itching decreased after 1 week of pentigetide treatment and remained decreased until study completion, whereas congestion was unchanged or slightly increased. In contrast, the frequency and severity of sneezing, rhinorrhea, and nasal itching increased after placebo treatment, with congestion essentially unchanged. No clinical or statistical differences in safety parameters between pentigetide and placebo treatments were observed. The results of this pilot trial suggested that subcutaneous pentigetide is safe and effective in the treatment of allergic rhinitis and justified expanded safety and efficacy studies in a greater number of patients treated for a longer period of time.

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