Vignes et al. (2007)

Vignes et al. (2007)
Design: Prospective case series (therapy), evidence level: 2+
Country: France
Inclusion criteria:
Women referred with upper limb lymphoedema secondary to treatment for breast cancer
Exclusion criteria:
Past history of attempted lymphoedema treatment by any means
Population:
Number of patients = 537, Females = 537, Median age = 62 years, range = 34-91 years
Interventions:
The programme consisted of an 11-day hospitalisation (intensive phase) of CDT followed by maintenance therapy undertaken by the patient and family at home. During the hospital phase, patients and family members were given instruction on bandaging techniques and skin care.

Complete (complex) decongestive therapy (CDT): Manual lymphatic drainage (30 minutes), low stretch compressive bandage wrapped in 2–4 layers over foam covering (worn for 24 hours daily) with exercise and elastic sleeve.

The first day of hospitalisation was considered day 1 of the study.
Outcomes:
Lymphoedema volume before and after CDT.
Follow up:
Baseline data collection included breast cancer staging and treatment, BMI and lymphoedema volume. The latter was calculated for each 5cm segment of the limb utilising a formula for measurement of a truncated cone. Measurements of limb volume were made by the same operator at study inclusion, after CDT and at 6 and 12 months. Details of maintenance therapy undertaken at home were recorded.

Missing data resulted in 2 women being excluded from the final analysis. During the one-year follow-up phase 24 (4%) participants died from causes not detailed.
Results:
Lymphoedema volume prior to intensive CDT = 1054 ± 633ml
Lymphoedema volume following intensive CDT = 647 ± 351ml (P < 0.0001)
Mean absolute volume reduction = 407ml (95%CI: −440 to −374 ml)

Foam padding was used in 70% of patients and cotton in the other 30%. At discharge, 86% patients were fitted with class 3 elastic sleeves (20–36 mmHg) and 14% were given class 2 (15–19 mmHg).

After 6 months (n = 426):
Mean increase in lymphoedema volume = 78 ml
Number of patients whose volume increased by > 10% = 217 (51%)
Number of patients whose volume was stable = 85 (20%)
Number of patients whose volume decreased = 124 (29%)

After 12 months (n = 356):
Mean increase in lymphoedema volume compared with volume after CDT = 84 ml
Mean increase in lymphoedema volume compared with volume after 6 months = 22 ml
Number of patients whose volume increased by >10% compared with volume after CDT = 186 (52%)
Number of patients whose volume was stable ± 10% compared with volume after CDT = 71 (20%)
Number of patients whose volume decreased compared with volume after CDT = 124 (28%)
During the maintenance phase, the risk of increase in limb volume due to lymphoedema of > 10% was more than 50% likely in those women not using a low stretch bandage (RR = 1.55, 95%CI: 1.3–1.76 P < 0.0001) or elastic sleeve (RR = 1.61 95%CI: 1.25–1.81 P = 0.002) – these factors were independent of each other. In contrast, the risk was unchanged whether or not people used MLD during this phase.
General comments:
This prospective cohort study followed 537 women for a one year maintenance period following CDT. Lymphoedema volume was measured before and after CDT and at 6 and 12 months. Each of the three components of therapy were separately evaluated. Participants were recruited between January 2001 and December 2004 at a single centre. The attrition rates were 21% after 6 months and 33% after one year which are acceptable.

The authors felt that this study design ensured as much as possible that heterogeneity had been minimised such that the results were more likely to be attributable to the interventions. However, they also pointed out that participants were not randomly allocated and hence the observed treatment effects may have been due to some unidentified confounding factors.

Recommendations from this study were that during the maintenance phase, after decongestive physiotherapy, patients should be advised to wear elastic sleeves every day with self bandages applied in the evening and worn throughout the night. A frequency of three bandages per week was believed to be optimal.

From: Chapter 6, Management of specific problems

Cover of Advanced Breast Cancer
Advanced Breast Cancer: Diagnosis and Treatment.
NICE Clinical Guidelines, No. 81.
National Collaborating Centre for Cancer (UK).
Copyright © 2009, National Collaborating Centre for Cancer.

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