A randomized, double-blind, placebo controlled, phase II study to evaluate the efficacy of ginseng in reducing fatigue in patients treated for head and neck cancer

Guglielmo, Mauro; Alfieri, Salvatore; Bergamini, Cristiana; Platini, Francesca; Ripamonti, Carla; Orlandi, Ester; Iacovelli, Nicola Alessandro; Licitra, Lisa; Maddalo, Marta; Bossi, Paolo

doi:10.1007/s00432-020-03300-z

Cited by 13 publications

(39 citation statements)

References 34 publications

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“… a All MID values are based on the publication Nordin et al 22 except for Boele et al 28 and Guglielmo et al 31 where MID is based on half of the standard deviation of the baseline values. 23 …”

Section: Resultsmentioning

confidence: 99%

“…The literature search identified 9880 records. Eventually, 15 RCTs were included in the qualitative synthesis, [26][27][28][29][30][31][32][33][34][35][36][37][38][39][40] of which five were included in the meta-analysis. 26,28,29,34,35 Details of the literature search and RCT selection can be found in Figure 1.…”

Section: Study Selectionmentioning

confidence: 99%

“…The sample size among included RCTs ranged from 18 to 443, with 13 RCTs (86.7%) recruiting less than 100 participants. [26][27][28][30][31][32][33][34][35][36][37][38][39] Among three RCTs providing related information, the average duration after completing cancer treatment ranged from 1.9 to 6.5 years.…”

Section: Characteristics Of Included Rctsmentioning

confidence: 99%

“…Types of pharmacological interventions included psychostimulant and wakefulness agents (5 RCTs), 26,28,29,34,35 natural products (5 RCTs), 27,[30][31][32][33] hormonal therapies (2 RCTs), 36,37 acetylcholinesterase inhibitor (1 RCT), 39 antidepressants (1 RCT), 38 and somatostatin analog (1 RCT). 40 Placebo was adopted as the control in all but two RCTs, 26,[28][29][30][31][32][33][34][35][36][38][39][40] of which no treatment was offered to control group patients in these two RCTs. 27,37 Intervention duration ranged from 1 to 52 weeks.…”

Section: Types Of Cancermentioning

confidence: 99%

“…The majority of RCTs presented some concerns of bias arising from the randomization process and selection of the reported results. Detailed results on risk except for Boele et al 28 and Guglielmo et al 31 where MID is based on half of the standard deviation of the baseline values. 23 of bias assessment along with supports for judgments are reported in Supplemental File, Appendix 4.…”

Section: Risk Of Bias Of Included Rctsmentioning

confidence: 99%

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Pharmacological Interventions for the Management of Cancer-Related Fatigue Among Cancer Survivors: Systematic Review and Meta-Analysis

et al. 2021

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Objective: Current guidelines have different recommendations on applying pharmacological interventions for managing cancer-related fatigue (CRF) among cancer survivors. This systematic review aims to synthesize clinical evidence on pharmacological interventions for managing CRF. Methods: Five databases were searched for potential randomized controlled trials (RCTs) from their inception until October 2020. RCTs assessing the effect of pharmacological treatments for CRF among cancer survivors were considered eligible. Clinical significance was determined by comparing the estimated effect with that of minimal important difference (MID). The risk of bias of each included RCT was appraised using the Cochrane risk of bias tool for randomized trials 2. Data were synthesized using random-effect pairwise meta-analyses. Results: A total of 15 RCTs (1238 participants) were included. The majority presented some concerns of bias arising from the randomization process and selection of the reported results. Meta-analysis showed that psychostimulant and wakefulness agents had statistically significant while clinically insignificant effects on the treatment of CRF (pooled weighted mean difference [WMD]: 2.8, 95% confidence interval [CI]: 0.2-5.4, I2: 0%, 3 RCTs, MID: 3.0-6.0). Three natural products, including Renshen Yangrong Tang (mean difference [MD]: −16.1, 95% CI: −8.9 to −23.3, MID: −17.3 to −11.4), Tualang honey (MD: 11.2, 95% CI: 7.1-15.3, MID: 3.0-6.0), and Shenmai injection plus Peptisorb (MD: −1.6, 95% CI: −2.1 to −1.1, MID: −1.1 to −0.8) demonstrated statistically and clinically significant effect in reducing CRF. Conclusions: Existing evidence showed promising effects of 3 natural products in reducing CRF among cancer survivors. The results from this study need to be further confirmed with well-designed and adequately powered RCTs that use validated instruments for the measurement of CRF.

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Section: Resultsmentioning

confidence: 99%

Section: Study Selectionmentioning

confidence: 99%

Section: Characteristics Of Included Rctsmentioning

confidence: 99%

Section: Types Of Cancermentioning

confidence: 99%

Section: Risk Of Bias Of Included Rctsmentioning

confidence: 99%

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Pharmacological Interventions for the Management of Cancer-Related Fatigue Among Cancer Survivors: Systematic Review and Meta-Analysis

et al. 2021

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Interventions for head and neck cancer survivors: Systematic review

et al. 2022

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Background Interventions for head/neck cancer (HNC) survivors may not address their cancer‐related and general health needs. Methods Preferred Reporting Items for Systematic Reviews and Meta‐Analysis (PRISMA) guided this systematic review of studies from 2000 to 2021 of interventions targeting cancer survivors treated with curative‐intent, using MEDLINE, Embase, Emcare, and PsycINFO. Interventions were categorized into domains of the Quality of Cancer Survivorship Care Framework to characterize the scope and quality of interventions. Results We identified 28 studies for inclusion: 13 randomized and 15 non‐randomized. Most targeted surveillance/management of physical effects (n = 24) including 13 that also targeted psychosocial effects. Four studies addressed prevention/surveillance for recurrence/new cancers, one addressed health promotion/disease prevention, and one addressed chronic medical conditions. Most studies (n = 27) had medium‐high risk of bias. Conclusions There are few high‐quality studies addressing HNC survivorship. Future rigorously designed studies should address broader areas of care, including chronic disease management and health promotion/disease prevention.

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