Letellier, M., Towers, A., Shimony, A., & Tidhar, D. (2014). Breast cancer-related lymphedema: A randomized controlled pilot and feasibility study. American Journal of Physical Medicine & Rehabilitation, 93, 751–763.

DOI Link

Study Purpose

To assess whether conducting a larger randomized, controlled trial of aqua lymphatic therapy (ALT) would be feasible and to estimate the extent to which ALT combined with home-based exercise compared with home-based exercise alone would reduce arm disability in patients with breast cancer-related lymphedema

Intervention Characteristics/Basic Study Process

Twenty-five women were randomly assigned to one of two groups, either ALT combined with home-based exercises or home-based exercises alone. Each woman was assessed before the intervention and after the 12-week intervention with pool-based therapy exercises. Arm volume, arm disability, pain, and quality of life were measured.

Sample Characteristics

  • N = 25  
  • AGE = Control group: 53.4 years (SD = 9.35 years), ALT group: 56.4 years (SD = 9.76 years)
  • FEMALES: 100%
  • KEY DISEASE CHARACTERISTICS: Breast cancer-related lymphedema
  • OTHER KEY SAMPLE CHARACTERISTICS: In remission from stage I or II breast cancer, wearing a well-fitted compression garment, at least two months after radiation or chemotherapy, and at least six months after surgery

Setting

  • SITE: Single-site    
  • SETTING TYPE: Outpatient    
  • LOCATION: McGill University Health Center, Montreal, Quebec

Phase of Care and Clinical Applications

  • APPLICATIONS: Elder care, palliative care 

Study Design

Single-blinded, randomized, controlled pilot study

Measurement Instruments/Methods

  • Participants' arm fluid volume was measured by water displacement volumetry and circumferential measurements.
  • Grip strength was measured using a baseline hand hydraulic dynamometer.
  • Pain was assessed using the short-form McGill Pain Questionnaire (MPQ).
  • Upper extremity function was measured using the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire.
  • Quality of life was assessed using the Functional Assessment of Cancer Therapy- Breast Cancer (FACT-B) version 4

Results

No reductions were found in limb volume in either group. Participants in the ALT group showed significant beneficial changes after 12 weeks of treatment, specifically on the Palliative Prognostic Index (PPI) score when compared to the control group (p = 0.025). There were no other significant improvements between groups. Within groups, there were significant improvements pre- and postintervention in healthy arm grip strength (p = .001 for both groups), affected arm grip strength (p = .008 for both groups), DASH scores (p = .016 in ALT group), FACT-B scores (p = .021 in ALT group), and PPI scores (p = .025 in ALT group).

Conclusions

A larger randomized, controlled trial would be feasible. ALT showed significant improvement in grip strength and DASH, FACT, and PPI scores after 12 weeks of ALT treatment. The intervention did not make lymphedema volume worse, and therefore it may be a safe alternative to land-based treatments of breast cancer-related lymphedema.

Limitations

  • Small sample (< 30)
  • Other limitations/explanation: Patients with open wounds would not be able to receive this intervention.

Nursing Implications

In this study, ALT showed no benefit in arm volume reduction over the control group. ALT was, however, effective at reducing pain intensity scores in the experimental group. Nurses should be aware that ALT does not appear to worsen limb volume in women with breast cancer who have been diagnosed with lymphedema, but it also does not improve limb volume. Nurses should note that ALT may be one potential intervention to help reduce the intensity of pain in breast cancer survivors with lymphedema.