Skip to main content
Erschienen in: Supportive Care in Cancer 4/2020

13.07.2019 | Original Article

The efficacy of placebo for the treatment of cancer-related fatigue: a systematic review and meta-analysis

verfasst von: Pedro Nazareth Aguiar Junior, Carmelia Maria Noia Barreto, Daniel de Iracema Gomes Cubero, Auro del Giglio

Erschienen in: Supportive Care in Cancer | Ausgabe 4/2020

Einloggen, um Zugang zu erhalten

Abstract

Purpose

Cancer-related fatigue (CRF) is a common symptom among patients with cancer. The efficacy of placebo, however, was never the main objective of any meta-analysis. Predicting the efficacy of placebo may facilitate researchers in designing future clinical trials for the treatment of CRF.

Methods

We performed a systematic review searching for prospective clinical trials comparing any treatment versus placebo for the treatment of CRF. We included studies that enrolled patients with any primary site of neoplasia and any stage of cancer. We excluded all studies that assessed fatigue related to any treatment. The primary endpoint of this study is the mean effect of placebo on fatigue according to the Functional Assessment of Chronic Illness (FACIT-F) and Brief Fatigue Inventory (BFI) scales. The secondary endpoint was the proportion of patients who reported improvement in fatigue (response rate).

Results

We found 520 studies, and 29 studies with 3758 participants were included in the meta-analysis. Placebo had a mean effect of + 4.88 (95%CI + 2.45 to + 7.29) using the FACIT-F scale, although it was statistically worse than the interventions studied (p = 0.005). Using the BFI scale, placebo had an average effect of + 0.64 (95%CI + 0.02 to + 1.30), although it was also worse than the other interventions studied (p = 0.002). In terms of the response rate, 29% (95%CI 25–32%) of patients taking a placebo reported a significant improvement in CRF compared with 36% of patients treated with other interventions (p = 0.030).

Conclusions

Placebo treatments had a significant effect on CRF, and predicting these effects may help design future studies for CRF.
Anhänge
Nur mit Berechtigung zugänglich
Literatur
2.
Zurück zum Zitat Mock V, Atkinson A, Barsevick A et al (2000) NCCN practice guidelines for cancer-related fatigue. Oncology (Williston Park) 14:151–161 Mock V, Atkinson A, Barsevick A et al (2000) NCCN practice guidelines for cancer-related fatigue. Oncology (Williston Park) 14:151–161
10.
Zurück zum Zitat Higgins J, Green S (2011) Cochrane handbook for systematic reviews of interventions. The Cochrane Collaboration Higgins J, Green S (2011) Cochrane handbook for systematic reviews of interventions. The Cochrane Collaboration
11.
16.
Zurück zum Zitat Balk J, Day R, Rosenzweig M, Beriwal S (2009) Pilot, randomized, modified, double-blind, placebo-controlled trial of acupuncture for cancer-related fatigue. J Soc Integr Oncol 7:4–11PubMed Balk J, Day R, Rosenzweig M, Beriwal S (2009) Pilot, randomized, modified, double-blind, placebo-controlled trial of acupuncture for cancer-related fatigue. J Soc Integr Oncol 7:4–11PubMed
17.
Zurück zum Zitat da Costa Miranda V, Trufelli DC, Santos J, Campos MP, Nobuo M, da Costa Miranda M, Schlinder F, Riechelmann R, del Giglio A (2009) Effectiveness of guaraná (Paullinia cupana ) for postradiation fatigue and depression: results of a pilot double-blind randomized study. J Altern Complement Med 15:431–433. https://doi.org/10.1089/acm.2008.0324 CrossRefPubMed da Costa Miranda V, Trufelli DC, Santos J, Campos MP, Nobuo M, da Costa Miranda M, Schlinder F, Riechelmann R, del Giglio A (2009) Effectiveness of guaraná (Paullinia cupana ) for postradiation fatigue and depression: results of a pilot double-blind randomized study. J Altern Complement Med 15:431–433. https://​doi.​org/​10.​1089/​acm.​2008.​0324 CrossRefPubMed
19.
Zurück zum Zitat Richard PO, Fleshner NE, Bhatt JR, Hersey KM, Chahin R, Alibhai SMH (2015) Phase II, randomised, double-blind, placebo-controlled trial of methylphenidate for reduction of fatigue levels in patients with prostate cancer receiving LHRH-agonist therapy. BJU Int 116:744–752. https://doi.org/10.1111/bju.12755 CrossRefPubMed Richard PO, Fleshner NE, Bhatt JR, Hersey KM, Chahin R, Alibhai SMH (2015) Phase II, randomised, double-blind, placebo-controlled trial of methylphenidate for reduction of fatigue levels in patients with prostate cancer receiving LHRH-agonist therapy. BJU Int 116:744–752. https://​doi.​org/​10.​1111/​bju.​12755 CrossRefPubMed
24.
Zurück zum Zitat Chen HW, Lin IH, Chen YJ, et al (2012) A novel infusible botanically-derived drug, PG2, for cancer-related fatigue: a phase II double-blind, randomized placebo-controlled study. Clin Investig Med 35:1–11CrossRef Chen HW, Lin IH, Chen YJ, et al (2012) A novel infusible botanically-derived drug, PG2, for cancer-related fatigue: a phase II double-blind, randomized placebo-controlled study. Clin Investig Med 35:1–11CrossRef
25.
Zurück zum Zitat Yennurajalingam S, Frisbee-Hume S, Palmer JL, Delgado-Guay MO, Bull J, Phan AT, Tannir NM, Litton JK, Reddy A, Hui D, Dalal S, Massie L, Reddy SK, Bruera E (2013) Reduction of cancer-related fatigue with dexamethasone: a double-blind, randomized, placebo-controlled trial in patients with advanced cancer. J Clin Oncol 31:3076–3082. https://doi.org/10.1200/JCO.2012.44.4661 CrossRefPubMed Yennurajalingam S, Frisbee-Hume S, Palmer JL, Delgado-Guay MO, Bull J, Phan AT, Tannir NM, Litton JK, Reddy A, Hui D, Dalal S, Massie L, Reddy SK, Bruera E (2013) Reduction of cancer-related fatigue with dexamethasone: a double-blind, randomized, placebo-controlled trial in patients with advanced cancer. J Clin Oncol 31:3076–3082. https://​doi.​org/​10.​1200/​JCO.​2012.​44.​4661 CrossRefPubMed
26.
Zurück zum Zitat Yennurajalingam S, Tannir NM, Williams JL, Lu Z, Hess KR, Frisbee-Hume S, House HL, Lim ZD, Lim KH, Lopez G, Reddy A, Azhar A, Wong A, Patel SM, Kuban DA, Kaseb AO, Cohen L, Bruera E (2017) A double-blind, randomized, placebo-controlled trial of panax ginseng for cancer-related fatigue in patients with advanced cancer. J Natl Compr Cancer Netw 15:1111–1120. https://doi.org/10.6004/jnccn.2017.0149 CrossRef Yennurajalingam S, Tannir NM, Williams JL, Lu Z, Hess KR, Frisbee-Hume S, House HL, Lim ZD, Lim KH, Lopez G, Reddy A, Azhar A, Wong A, Patel SM, Kuban DA, Kaseb AO, Cohen L, Bruera E (2017) A double-blind, randomized, placebo-controlled trial of panax ginseng for cancer-related fatigue in patients with advanced cancer. J Natl Compr Cancer Netw 15:1111–1120. https://​doi.​org/​10.​6004/​jnccn.​2017.​0149 CrossRef
27.
Zurück zum Zitat Barton DL, Soori GS, Bauer BA, Sloan JA, Johnson PA, Figueras C, Duane S, Mattar B, Liu H, Atherton PJ, Christensen B, Loprinzi CL (2010) Pilot study of Panax quinquefolius (American ginseng) to improve cancer-related fatigue: a randomized, double-blind, dose-finding evaluation: NCCTG trial N03CA. Support Care Cancer 18:179–187. https://doi.org/10.1007/s00520-009-0642-2 CrossRefPubMed Barton DL, Soori GS, Bauer BA, Sloan JA, Johnson PA, Figueras C, Duane S, Mattar B, Liu H, Atherton PJ, Christensen B, Loprinzi CL (2010) Pilot study of Panax quinquefolius (American ginseng) to improve cancer-related fatigue: a randomized, double-blind, dose-finding evaluation: NCCTG trial N03CA. Support Care Cancer 18:179–187. https://​doi.​org/​10.​1007/​s00520-009-0642-2 CrossRefPubMed
29.
Zurück zum Zitat Berenson JR, Yellin O, Shamasunder HK, Chen CS, Charu V, Woliver TB, Sanani S, Schlutz M, Nassir Y, Swift RA, Andreu-Vieyra C, Vescio R (2015) A phase 3 trial of armodafinil for the treatment of cancer-related fatigue for patients with multiple myeloma. Support Care Cancer 23:1503–1512. https://doi.org/10.1007/s00520-014-2486-7 CrossRefPubMed Berenson JR, Yellin O, Shamasunder HK, Chen CS, Charu V, Woliver TB, Sanani S, Schlutz M, Nassir Y, Swift RA, Andreu-Vieyra C, Vescio R (2015) A phase 3 trial of armodafinil for the treatment of cancer-related fatigue for patients with multiple myeloma. Support Care Cancer 23:1503–1512. https://​doi.​org/​10.​1007/​s00520-014-2486-7 CrossRefPubMed
37.
Zurück zum Zitat Mar Fan HG, Clemons M, Xu W, Chemerynsky I, Breunis H, Braganza S, Tannock IF (2008) A randomised, placebo-controlled, double-blind trial of the effects of d-methylphenidate on fatigue and cognitive dysfunction in women undergoing adjuvant chemotherapy for breast cancer. Support Care Cancer 16:577–583. https://doi.org/10.1007/s00520-007-0341-9 CrossRefPubMed Mar Fan HG, Clemons M, Xu W, Chemerynsky I, Breunis H, Braganza S, Tannock IF (2008) A randomised, placebo-controlled, double-blind trial of the effects of d-methylphenidate on fatigue and cognitive dysfunction in women undergoing adjuvant chemotherapy for breast cancer. Support Care Cancer 16:577–583. https://​doi.​org/​10.​1007/​s00520-007-0341-9 CrossRefPubMed
38.
Zurück zum Zitat Heckler CE, Garland SN, Peoples AR, Perlis ML, Shayne M, Morrow GR, Kamen C, Hoefler J, Roscoe JA (2016) Cognitive behavioral therapy for insomnia, but not armodafinil, improves fatigue in cancer survivors with insomnia: a randomized placebo-controlled trial. Support Care Cancer 24:2059–2066. https://doi.org/10.1007/s00520-015-2996-y CrossRefPubMed Heckler CE, Garland SN, Peoples AR, Perlis ML, Shayne M, Morrow GR, Kamen C, Hoefler J, Roscoe JA (2016) Cognitive behavioral therapy for insomnia, but not armodafinil, improves fatigue in cancer survivors with insomnia: a randomized placebo-controlled trial. Support Care Cancer 24:2059–2066. https://​doi.​org/​10.​1007/​s00520-015-2996-y CrossRefPubMed
39.
Metadaten
Titel
The efficacy of placebo for the treatment of cancer-related fatigue: a systematic review and meta-analysis
verfasst von
Pedro Nazareth Aguiar Junior
Carmelia Maria Noia Barreto
Daniel de Iracema Gomes Cubero
Auro del Giglio
Publikationsdatum
13.07.2019
Verlag
Springer Berlin Heidelberg
Erschienen in
Supportive Care in Cancer / Ausgabe 4/2020
Print ISSN: 0941-4355
Elektronische ISSN: 1433-7339
DOI
https://doi.org/10.1007/s00520-019-04977-w

Weitere Artikel der Ausgabe 4/2020

Supportive Care in Cancer 4/2020 Zur Ausgabe

Update Onkologie

Bestellen Sie unseren Fach-Newsletter und bleiben Sie gut informiert.