Treish, I., Shord, S., Valgus, J., Harvey, D., Nagy, J., Stegal, J., & Lindley, C. (2003). Randomized double-blind study of the Reliefband as an adjunct to standard antiemetics in patients receiving moderately-high to highly emetogenic chemotherapy. Supportive Care in Cancer, 11, 516-521.

DOI Link

Intervention Characteristics/Basic Study Process

Adult cancer patients receiving moderately emetogenic chemotherapy (MEC) or highly emetogenic chemotherapy (HEC) were randomized to receive the active ReliefBand® or an inactive device. All patients received scheduled and as-needed antiemetics. Patients wore devices continuously for five days, except during showering and hand washing.

Sample Characteristics

  • The study consisted of 49 patients.
  • Mean age was 45 years.
  • Diagnoses included leukemia, non-Hodgkin lymphoma, sarcoma, breast, head and neck, and lung cancer.
  • A variety of chemotherapy regimens were reported that met criteria for MEC or HEC. Many subjects had three to four prior chemotherapy cycles. All received single- or multiday chemotherapy, including myeloablative chemotherapy, for bone marrow transplant.

Setting

All participants in this single-site study were inpatients at the University of North Carolina Hospitals.

Study Design

The study design was a randomized, prospective, double-blind, placebo-controlled trial.

Measurement Instruments/Methods

  • Patients recorded nausea, vomiting, retching episodes, and antiemetic medications use in diaries daily.
  • The Functional Living Index Emesis and tolerability survey were completed at the conclusion of the study.

Results

Patients wearing the ReliefBand experienced less vomiting, retching, and nausea severity over the five-day period than patients wearing the inactive device. Vomiting was statistically and significantly reduced during the delayed period, and nausea was significantly reduced during the acute and delayed periods. Functional Living Index Emesis scores did not differ between the two groups.

Limitations

  • Differences existed in risk factors for emesis, chemotherapy, and antiemetic regimens.
  • The sample size was small.
  • Patients with pacemakers, low life expectancy, and poor performance status (greater than three) were excluded.