Manual lymphatic drainage adds no further volume reduction to Complete Decongestive Therapy on breast cancer-related lymphoedema: a multicentre, randomised, single-blind trial

Mette Tambour, Marianne Holt, Anette Speyer, Robin Christensen, Bibi Gram*

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Resumé

Background: We investigated the comparability of Complete Decongestive Therapy (CDT) including manual lymphatic drainage (MLD) vs. without MLD in the management of arm lymphoedema in patients with breast cancer. Methods: Patients randomised into either treatment including MLD (T+MLD) or treatment without MLD (T−MLD) received treatment 2×weekly for 4 weeks. The primary outcome was the volume reduction (%) of arm lymphoedema at 7-month follow-up. The secondary outcomes were volume reduction after the end of treatment, circumference of the arm, patient experience of heaviness and tension, and health status. Results: Despite difficulties enrolling the planned number of patients (160), 77 were randomised and 73 (38 in T+MLD, 35 in T−MLD) completed the trial. In both groups, the volume of lymphoedema decreased significantly, with no difference between groups (1.0% [95% CI, −4.3;2.3%]): the precision in the 95% confidence interval indicates that the efficacy was comparable; the mean (SE) changes at month 7 were −6.8%(1.2) and −5.7% (1.2) in the T+MLD and T−MLD, respectively. There were no statistically significant differences with respect to any of the secondary outcomes. The results were robust and the conclusion was not sensitive even to various alternative assumptions or analytic approaches to data analysis. Conclusion: Manual lymphatic drainage adds no further volume reduction in breast cancer patients.

OriginalsprogEngelsk
TidsskriftBritish Journal of Cancer
Vol/bind119
Udgave nummer10
Sider (fra-til)1215–1222
ISSN0007-0920
DOI
StatusUdgivet - 13. nov. 2018

Fingeraftryk

Lymphedema
Breast Cancer Lymphedema
Confidence Intervals

Citer dette

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title = "Manual lymphatic drainage adds no further volume reduction to Complete Decongestive Therapy on breast cancer-related lymphoedema: a multicentre, randomised, single-blind trial",
abstract = "Background: We investigated the comparability of Complete Decongestive Therapy (CDT) including manual lymphatic drainage (MLD) vs. without MLD in the management of arm lymphoedema in patients with breast cancer. Methods: Patients randomised into either treatment including MLD (T+MLD) or treatment without MLD (T−MLD) received treatment 2×weekly for 4 weeks. The primary outcome was the volume reduction ({\%}) of arm lymphoedema at 7-month follow-up. The secondary outcomes were volume reduction after the end of treatment, circumference of the arm, patient experience of heaviness and tension, and health status. Results: Despite difficulties enrolling the planned number of patients (160), 77 were randomised and 73 (38 in T+MLD, 35 in T−MLD) completed the trial. In both groups, the volume of lymphoedema decreased significantly, with no difference between groups (1.0{\%} [95{\%} CI, −4.3;2.3{\%}]): the precision in the 95{\%} confidence interval indicates that the efficacy was comparable; the mean (SE) changes at month 7 were −6.8{\%}(1.2) and −5.7{\%} (1.2) in the T+MLD and T−MLD, respectively. There were no statistically significant differences with respect to any of the secondary outcomes. The results were robust and the conclusion was not sensitive even to various alternative assumptions or analytic approaches to data analysis. Conclusion: Manual lymphatic drainage adds no further volume reduction in breast cancer patients.",
author = "Mette Tambour and Marianne Holt and Anette Speyer and Robin Christensen and Bibi Gram",
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Manual lymphatic drainage adds no further volume reduction to Complete Decongestive Therapy on breast cancer-related lymphoedema : a multicentre, randomised, single-blind trial. / Tambour, Mette; Holt, Marianne; Speyer, Anette; Christensen, Robin; Gram, Bibi.

I: British Journal of Cancer, Bind 119, Nr. 10, 13.11.2018, s. 1215–1222.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

TY - JOUR

T1 - Manual lymphatic drainage adds no further volume reduction to Complete Decongestive Therapy on breast cancer-related lymphoedema

T2 - a multicentre, randomised, single-blind trial

AU - Tambour, Mette

AU - Holt, Marianne

AU - Speyer, Anette

AU - Christensen, Robin

AU - Gram, Bibi

PY - 2018/11/13

Y1 - 2018/11/13

N2 - Background: We investigated the comparability of Complete Decongestive Therapy (CDT) including manual lymphatic drainage (MLD) vs. without MLD in the management of arm lymphoedema in patients with breast cancer. Methods: Patients randomised into either treatment including MLD (T+MLD) or treatment without MLD (T−MLD) received treatment 2×weekly for 4 weeks. The primary outcome was the volume reduction (%) of arm lymphoedema at 7-month follow-up. The secondary outcomes were volume reduction after the end of treatment, circumference of the arm, patient experience of heaviness and tension, and health status. Results: Despite difficulties enrolling the planned number of patients (160), 77 were randomised and 73 (38 in T+MLD, 35 in T−MLD) completed the trial. In both groups, the volume of lymphoedema decreased significantly, with no difference between groups (1.0% [95% CI, −4.3;2.3%]): the precision in the 95% confidence interval indicates that the efficacy was comparable; the mean (SE) changes at month 7 were −6.8%(1.2) and −5.7% (1.2) in the T+MLD and T−MLD, respectively. There were no statistically significant differences with respect to any of the secondary outcomes. The results were robust and the conclusion was not sensitive even to various alternative assumptions or analytic approaches to data analysis. Conclusion: Manual lymphatic drainage adds no further volume reduction in breast cancer patients.

AB - Background: We investigated the comparability of Complete Decongestive Therapy (CDT) including manual lymphatic drainage (MLD) vs. without MLD in the management of arm lymphoedema in patients with breast cancer. Methods: Patients randomised into either treatment including MLD (T+MLD) or treatment without MLD (T−MLD) received treatment 2×weekly for 4 weeks. The primary outcome was the volume reduction (%) of arm lymphoedema at 7-month follow-up. The secondary outcomes were volume reduction after the end of treatment, circumference of the arm, patient experience of heaviness and tension, and health status. Results: Despite difficulties enrolling the planned number of patients (160), 77 were randomised and 73 (38 in T+MLD, 35 in T−MLD) completed the trial. In both groups, the volume of lymphoedema decreased significantly, with no difference between groups (1.0% [95% CI, −4.3;2.3%]): the precision in the 95% confidence interval indicates that the efficacy was comparable; the mean (SE) changes at month 7 were −6.8%(1.2) and −5.7% (1.2) in the T+MLD and T−MLD, respectively. There were no statistically significant differences with respect to any of the secondary outcomes. The results were robust and the conclusion was not sensitive even to various alternative assumptions or analytic approaches to data analysis. Conclusion: Manual lymphatic drainage adds no further volume reduction in breast cancer patients.

U2 - 10.1038/s41416-018-0306-4

DO - 10.1038/s41416-018-0306-4

M3 - Journal article

C2 - 30353049

AN - SCOPUS:85055564491

VL - 119

SP - 1215

EP - 1222

JO - B J C

JF - B J C

SN - 0007-0920

IS - 10

ER -