Effect Of Nerve Stimulation Therapy On Chemotherapy Induced Emesis (Cie): A Randomized, Placebo Controlled Trial Evaluating The Efficacy Of The Reliefband (Rb) Device

Reviewer: Heather Jones, MD
The Abramson Cancer Center of the University of Pennsylvania
Last Modified: May 18, 2002

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Presenter: Imad M Treish
Presenter's Affiliation: University of North Carolina
Type of Session: Scientific

Background

    Despite the improvements made in treating chemotherapy-induced nausea and vomiting (CINV), they remain some of patients' most feared effects of cancer treatment. Approximately, 70% to 80% of all patients who receive chemotherapy experience nausea and vomiting. Anticipatory nausea and vomiting are experienced by approximately 10% to 44% of patients who receive chemotherapy. Studies have demonstrated that stimulation of the Neiguan (P6) point, located on the inner surface of the wrist, has been shown to alleviate the incidence and severity of CINV. Reliefbands (RB) is an FDA approved device for treatment of emesis associated with chemotherapy, pregnancy, and motion sickness. RB delivers intermittent electrical pulses ranging from 10-35 mAmps to the P6 point. The study looked at the use of RB nerve stimulation in the prevention of CINV.

Materials and Methods

  • This is a randomized, double-blind, placebo-controlled study
  • 50 adult patients were randomized to an active RB device or a placebo device for 5 days following chemotherapy in addition to standard antiemetic regimen as per ASCO guidelines
  • Patients on study received highly emetogenic chemotherapy including BMT regiments as well as, leukemia induction regimen, and other highly emetogenic chemotherapy regimens for solid tumors
  • A Mann-Whitney test was used to evaluate the difference between treatment arms in terms of the: number emetic episodes, severity of nausea on a visual analog scale(VAS), and Functional Living Index Emesis (FLIE)

Results

  • Patients randomized to active RB had significantly lesser number of emetic episodes (1.9 vs. 4.6 p=0.050)
  • They reported less nausea on a 10-point VAS (1.5 vs. 3.1 p=0.018)
  • They reported less retching (0.51 vs. 1.3 p=0.049) than those randomized to placebo RB
  • Mean FLIE scores for patients receiving active RB were higher than those receiving placebo RB (91 vs. 80 p=0.088).
  • None of the patients randomized to active RB experienced any serious side effects related to wearing the RB. However, 2 RB patients did complain of wrist irritation

Author's Conclusions

    The authors felt that the data demonstrated RB to be an effective adjunct therapy for the reduction of CINV symptoms.

Clinical/Scientific Implications

    While we have made important strides in treating chemotherapy-induced emesis with more active agents, our patients continue to indicate that we must do better. We should continue to look for novel and cost effective ways to treat nausea and vomiting in patients. It would seem that the use of Reliefbands reduces the severity of nausea and vomiting in this patient population. However, we should continue to strive for not only reduction but also prevention and elimination of these distressing side effects of therapy.

Oncolink's ASCO Coverage made possible by an unrestricted Educational Grant from Bristol-Myers Squibb Oncology.


News
Majority of randomized controlled oncology trials assess treatments available outside trials

Nov 2, 2010 - Most recent oncology randomized controlled trials evaluate drugs that are available "off-protocol therapy" in the United States, and this can adversely impact trial enrollment, according to a study published online Oct. 25 in the Journal of Clinical Oncology.


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