Supportive Care in Cancer

, Volume 11, Issue 8, pp 516–521 | Cite as

Randomized double-blind study of the Reliefband as an adjunct to standard antiemetics in patients receiving moderately-high to highly emetogenic chemotherapy

  • Imad Treish
  • Stacy Shord
  • John Valgus
  • Donald Harvey
  • Jessica Nagy
  • Jennifer Stegal
  • Celeste Lindley
Original Article

Abstract

Goals

Our goal was to evaluate the efficacy and tolerability of the Reliefband as an adjunct to standard antiemetics in patients receiving moderately-high to highly emetogenic chemotherapy.

Patients and methods

Forty-nine adult cancer patients receiving moderately-high or highly emetogenic chemotherapy were randomized to receive either the active Reliefband (n=26) or an inactive device (n=23). Patients continued to receive all scheduled and as needed antiemetic agents as prescribed. The device was worn the day of chemotherapy administration for 5 days (days 1–5). Patients maintained a daily dairy of nausea severity, vomiting and retching episodes, and antiemetic medications taken. Each patient completed a Functional Living Index Emesis (FLIE) and a tolerability survey at the conclusion of the study. A Wilcoxon rank sum test was used to compare the number of vomiting episodes, severity of nausea and FLIE scores between the two groups.

Main results

Patients wearing the active Relifband experienced less vomiting (Reliefband 1.9 versus inactive device 4.6 mean episodes; p=0.05), retching (1.4 versus 3.6 mean episodes; p=0.05), and nausea severity (0.91 versus 1.65 mean cm/day; p=0.01) over the 5-day period compared to patients wearing the inactive device. Vomiting was statistically significantly reduced during the delayed period (0.42 versus 1; p=0.032), whereas nausea was significantly reduced during the acute (0.71 versus 2.3; p=0.028) and delayed (1.8 versus 3.3; p=0.020) periods. FLIE scores did not differ between the two treatment groups (91 versus 80; p=0.088).

Conclusions

This study suggests that patients receiving moderately-high to highly emetogenic chemotherapy who experience nausea and vomiting despite scheduled antiemetics may benefit from the use of the Reliefband as an adjunct to antiemetics. Limitations of this study include differences in risk factors for emesis, chemotherapy, and antiemetic regimens. A larger, better, controlled randomized study is needed to better define optimal use of this device.

Keywords

Acustimulation Transcutaneous electrical stimulation Acupressure Nausea Vomiting Chemotherapy Reliefband 

References

  1. 1.
    Abang AM, Takemoto MH, Pham T, Mandanas RA, Roy V, Selby GB, et al (2000) Efficacy and safety of oral granisetron versus i.v. granisetron in patients undergoing peripheral blood progenitor cell and bone marrow transplantation. Anticancer Drugs 11:(2)137–142Google Scholar
  2. 2.
    Anonymous (1995) Ondansetron versus granisetron, both combined with dexamethasone, in the prevention of cisplatin-induced emesis. Italian Group of Antiemetic Research. Ann Oncol 6:805–810PubMedGoogle Scholar
  3. 3.
    Anonymous (1999) ASHP Therapeutic guidelines on the pharmacologic management of nausea and vomiting in adult and pediatric patients receiving chemotherapy or radiation therapy or undergoing surgery. Am J Healthsystem Pharm 56:(8)729–764Google Scholar
  4. 4.
    Birch R, Weaver CH, Carson K, Buckner CD (1998) A randomized trial of once vs twice daily administration of intravenous granisetron with dexamethosone in patients receiving high-dose cyclophosphamide, thiotepa and carboplatin. Bone 22:(7)685–8Google Scholar
  5. 5.
    Bshunow PW, Matteson SE, Morrow G, Roscoe J (2002) Patients with intractable chemotherapy-induced nausea find acustimulation band helpful. Procedings of the annual meeting, Am Soc Clin Oncol 22: AbstractGoogle Scholar
  6. 6.
    Campos D, Pereira JR, Reinhardt RR, Carracedo C, Poli S, Vogel C, et al (2001) Prevention of cisplatin-induced emesis by the oral neurokinin-1 antagonist, MK-869, in combination with granisetron and dexamethasone or with dexamethasone alone. J Clin Oncol 15 19:(6)1759–1767Google Scholar
  7. 7.
    Cocquyt V, Van Belle S, Reinhardt RR, Decramer ML, O'Brien M, Schellens JH et al (2001) Comparison of L-758,298, a prodrug for the selective neurokinin-1 antagonist, L-754,030, with ondansetron for the prevention of cisplatin-induced emesis. Eur J Cancer 37:835–842CrossRefPubMedGoogle Scholar
  8. 8.
    Dundee JW. (1990) Belfast experience with P6 acupuncture antiemesis. Ulster Med J 59:63–70PubMedGoogle Scholar
  9. 9.
    Dundee JW, Ghaly RG, Fitzpatrick KT, Abram WP, Lynch GA. (1989) Acupuncture prophylaxis of cancer chemotherapy-induced sickness. J R Soc Med 82:268–271PubMedGoogle Scholar
  10. 10.
    Dundee JW, McMillan CM (1990) Clinical uses of P6 acupuncture antiemesis. Acupunct Electrother Res 15:211–215PubMedGoogle Scholar
  11. 11.
    Dundee JW, Yang J (1990) Prolongation of the antiemetic action of P6 acupuncture by acupressure in patients having cancer chemotherapy. J R Soc Med 83:360–362PubMedGoogle Scholar
  12. 12.
    Dundee JW, Yang J, Ghaly RG (1990) Vomiting and chemotherapy. Lancet 335:541Google Scholar
  13. 13.
    Dundee JW, Yang J, McMillan C (1991) Non-invasive stimulation of the P6 (Neiguan) antiemetic acupuncture point in cancer chemotherapy. J R Soc Med 84:210–212PubMedGoogle Scholar
  14. 14.
    Dranitsaris G, Leung P, Ciotti R, Ortega A, Spinthouri M, Liaropoulos L, et al (2001) A multinational study to measure the value that patients with cancer place on improved emesis control following cisplatin chemotherapy. Pharmacoeconomics 19(9):955–67PubMedGoogle Scholar
  15. 15.
    Gralla RJ, Osoba D, Kris MG, Kirkbride P, Hesketh PJ, Chinnery LW, et al (1999) Recommendations for the use of antiemetics: evidence-based, clinical practice guidelines. American Society of Clinical Oncology. [erratum appears in J Clin Oncol 1999 Dec;17(12):3860; J Clin Oncol 2000 Aug;18(16):3064]. J Clin Oncol 17:2971–2994PubMedGoogle Scholar
  16. 16.
    Griffin AM, Butow PN, Coates AS, Childs AM, Ellis PM, Dunn SM, et al (1996) On the receiving end. V: Patient perceptions of the side effects of cancer chemotherapy in 1993. Ann Onc 7:(2)189–195Google Scholar
  17. 17.
    Grunberg SM, Boutin N, Ireland A, Miner S, Silveira J, Ashikaga T (1996) Impact of nausea/vomiting on quality of life as a visual analogue scale-derived utility score. Support Care Cancer 4:(6)435–439Google Scholar
  18. 18.
    Herrington JD, Kwan P, Young RR, Lagow E, Lagrone L, Riggs MW (2000) Randomized, multicenter comparison of oral granisetron and oral ondansetron for emetogenic chemotherapy. Pharmacotherapy 20:1318–1323PubMedGoogle Scholar
  19. 19.
    Hesketh PJ, Gralla RJ, Webb RT, Ueno W, DelPrete S, Bachinsky ME, et al (1999) Randomized phase II study of the neurokinin 1 receptor antagonist CJ-11, 974 in the control of cisplatin-induced emesis. J Clin Oncol 17:(1)338–343Google Scholar
  20. 20.
    Hesketh PJ, Kris MG, Grunberg SM, Beck T, Hainsworth JD, Harker G, et al (1997) Proposal for classifying the acute emetogenicity of cancer chemotherapy. J Clin Oncol 15:103–109PubMedGoogle Scholar
  21. 21.
    Pearson J, Blumentals W, Martin A, Carides A, Horgan K, Wittreich J, et al (2000) Validation of Functional Living Index-Emesis (FLIE) Quality-of-life questionnaire for acute and delayed chemotherapy-induced emesis. Proceedings of the annual meeting, Am Soc Clin Oncol 20:2384Google Scholar
  22. 22.
    Laszlo J (1983) Nausea and vomiting as major complications of cancer chemotherapy. Drugs [Suppl 1] 25:1–7Google Scholar
  23. 23.
    Lindley CM, Hirsch JD, O'Neill CV, Transau MC, Gilbert CS, Osterhaus JT (1992) Quality of life consequences of chemotherapy-induced emesis. Qual Life Res 1:331–340PubMedGoogle Scholar
  24. 24.
    Navari RM, Reinhardt RR, Gralla RJ, Kris MG, Hesketh PJ, Khojasteh A, et al (1999) Reduction of cisplatin-induced emesis by a selective neurokinin-1-receptor antagonist. L-754, 030 Antiemetic Trials Group. New Eng J Med 340:(3)190–195Google Scholar
  25. 25.
    Orchard PJ, Rogosheske J, Burns L, Rydholm N, Larson H, DeFor TE, et al (1999) A prospective randomized trial of the anti-emetic efficacy of ondansetron and granisetron during bone marrow transplantation. Biol Blood Marrow Transplant 5:(6)386–393Google Scholar
  26. 26.
    Osoba D, Zee B, Warr D, Latreille J, Kaizer L, Pater J (1997) Effect of postchemotherapy nausea and vomiting on health-related quality of life. The quality of life and symptom control committees of the National Cancer Institute of Canada Clinical Trials Group. Support Care Cancer 5:(4)307–313Google Scholar
  27. 27.
    Osowski CL, Dix SP, Lynn M, Davidson T, Cohen L, Miyahara T, et al (1998) An open-label dose comparison study of ondansetron for the prevention of emesis associated with chemotherapy prior to bone marrow transplantation. Support Care Cancer 6:511–517CrossRefPubMedGoogle Scholar
  28. 28.
    Oyama H, Kaneda M, Katsumata N, Akechi T, Ohsuga M. (2000) Using the bedside wellness system during chemotherapy decreases fatigue and emesis in cancer patients. J Med Syst 24:173–182CrossRefPubMedGoogle Scholar
  29. 29.
    Pearl ML, Fischer M, McCauley DL, Valea FA, Chalas E. (1999) Transcutaneous electrical nerve stimulation as an adjunct for controlling chemotherapy-induced nausea and vomiting in gynecologic oncology patients. Cancer Nurs 22:307–311PubMedGoogle Scholar
  30. 30.
    Saller R, Hellenbrecht D, Buhring M, Hess H. (1986) Enhancement of the antiemetic action of metoclopramide against cisplatin-induced emesis by transdermal electrical nerve stimulation. J Clin Pharmacol 26:115–119PubMedGoogle Scholar
  31. 31.
    Sigsgaard T, Herrstedt J, Handberg J, Kjaer M, Dombernowsky P (2001) Ondansetron plus metopimazine compared with ondansetron plus metopimazine plus prednisolone as antiemetic prophylaxis in patients receiving multiple cycles of moderately emetogenic chemotherapy. J Clin Onc 19:(7)2091–2097Google Scholar
  32. 32.
    Vincent CA, Richardson PH (1986) The evaluation of therapeutic acupuncture: concepts and methods. Pain. 24:(1)1–13Google Scholar

Copyright information

© Springer-Verlag 2003

Authors and Affiliations

  • Imad Treish
    • 1
  • Stacy Shord
    • 1
  • John Valgus
    • 1
  • Donald Harvey
    • 1
  • Jessica Nagy
    • 1
  • Jennifer Stegal
    • 1
  • Celeste Lindley
    • 1
    • 2
  1. 1.University of North Carolina HospitalsChapel HillUSA
  2. 2.University of North Carolina School of PharmacyUniversity of North CarolinaChapel HillUSA

Personalised recommendations