Fife, C.E., Davey, S., Maus, E.A., Guilliod, R., & Mayrovitz, H.N. (2012). A randomized controlled trial comparing two types of pneumatic compression for breast cancer-related lymphedema treatment in the home. Supportive Care in Cancer: Official Journal of the Multinational Association of Supportive Care in Cancer, 20(12), 3279–3286.

DOI Link

Study Purpose

To determine whether an advanced pneumatic compression device provides better results in reducing arm lymphedema than a standard compression device

Intervention Characteristics/Basic Study Process

Patients with confirmed upper-extremity lymphedema were randomly assigned to home treatments with either the standard or advanced device for 12 weeks. Study measurements were done at baseline and at week 12. The assigned device was used 1 hour per day in addition to routine care, including compression garment wear for 23 hours per day. The standard device was a gradient sequential pneumatic compressor that attaches to an arm garment. The advanced device attaches to three garments that treat the full upper extremity, including the arm and adjacent chest and truncal quadrant. Measures of outcome included local tissue water measurement using the tissue dielectric constant method and arm circumferences measured with a no stretch retractable tape measure calibrated to 4 oz of tension.

Sample Characteristics

  • The study sample (N = 36) was comprised of femal patients who had breast cancer surgery with node dissection.
  • Mean age was 56.8 years.
  • The majority of patients had adjunctive chemotherapy and radiation therapy.  
  • All patients had at least 5% edema volume of the arm. 
  • All treatment was completed at least three months prior to study entry.

 

Setting

The study took place across multiple sites in the United States in home settings.
 

Phase of Care and Clinical Applications

Patients were undergoing the transition stage of care after initial treatment. The study has clinical applicability for late effects and survivorship.
 

Study Design

The study used a randomized controlled trial design.

Measurement Instruments/Methods

  • Arm circumference was measured.
  • A tissue water measurement was taken.
     

Results

Total edema volume was not statistically different between groups at baseline or at 12 weeks; however, there was a group by time difference in repeated measures analysis in favor of the advanced device (p = 0.05).  The advanced device edema mean volume went from 556 ml at baseline to 438 ml at week 12.  Device compliance was 95% in the advanced group and 99% in the standard device group. Adverse events that were considered to be possibly or definitely device related included increased arm swelling, breast inflammation, pain, fibrosis and infection, increased hand swelling, arm pain, finger numbness, increased swelling of torso, pain in axilla and back in the standard device group, and increased swelling of the lymph nodes in the contralateral axilla in the advanced device group. The prevalence of these events is not reported.

Conclusions

Findings suggest that the use of the advanced pneumatic compression device may provide better outcomes in terms of arm edema. Further research is needed to evaluate adverse events

Limitations

  • The sample size was small, with less than 100 patients.
  • There were no patient-centered outcome measures to determine if differences in arm volume were associated with less patient discomfort.
  • The follow-up was relatively short.
  • The study has a potential of bias because of no blinding.
     

Nursing Implications

The use of this advanced type of pneumatic compression may provide better results in terms of arm edema reduction. It is not clear if the differences seen here would continue to be significant long term or if the patients’ experience of arm discomfort and the acceptance of the treatment would also be better.