Early intervention with compression garments prevents progression in mild breast cancer-related arm lymphedema: a randomized controlled trial

Figures & data

Figure 1. Flowchart of recruitment of the participants and treatment allocation.

Table 1. Participant characteristics of women with mild breast cancer related arm lymphedema, in the compression group (CG) and noncompression group (NCG), (n = 70).

	CG N = 33	NCG N = 37	p-Value*
Age in years at diagnosis, mean (SD)	57.9 (13.8)	57.0 (12.5)	0.795
Education^a			0.067^c
Elementary school, n	2	5
Upper secondary school, n	10	18
University/college, n	21	13
Marital status, single/partner, n	9/24	12/25	0.638
BMI kg/m², mean (SD)	26.1 (4.8)	27.2 (5.4)	0.390
Surgery			0.033
Mastectomy and ALND, n (%)	20 (61)	13 (35)
Lumpectomy and ALND, n (%)	13 (39)	24 (65)
Reconstruction, n (%)	3 (9)	2 (5)	0.661^c
Lymph nodes
Removed at surgery, mean (SD)	14.9 (5.8)	16.0 (5.5)	0.397
With metastasis, mean (SD)	2.3 (3.0)	2.6 (2.4)	0.655
Affected side, right/left, n	18/15	19/18	0.789
Surgery dominant side^a, n (%)	19 (58)	17 (47)	0.390
Oncological treatment
Radiotherapy, n (%)	32 (97)	37 (100)	0.471^c
Chemotherapy, n (%)	27 (82)	33 (89)	0.499^c
Hormone therapy, n (%)	25 (76)	28 (76)	0.994
Lymphedema
Time from surgery to onset, months, mean (SD)	6.1 (5.5)	6.6 (5.2)	0.721
Duration, months, mean (SD)	1.0 (1.3)	1.0 (1.5)	0.834
Total arm volume, affected side, ml	2530 (447)	2498 (470)	0.771
Total arm volume, nonaffected side, ml	2421 (439)	2412 (477)	0.937
Absolute arm volume, ml	109 (88)	85 (100)	0.309
Relative volume, % adjusted^b, mean (SD)	4.4 (3.1)	3.8 (3.5)	0.456
TDC ratio highest value, mean (SD)	1.53 (0.21)	1.51 (0.30)	0.782

ALND: axillary lymph node dissection. *Significance level 0.05, bold values are significant, Pearson Chi-square test for nominal data, Mann–Whitney U-test for ordinal data, T-test for continuous data, ^amissing value:1, ^bAdjusted with +1.5%, if surgery in non-dominant side, and −1.5% if surgery in dominant side. ^cFisher’s exact test.

Table 2. Proportion of participants with no progression/ progression of lymphedema relative volume (LRV) over 6 months in the compression group (CG) and noncompression group (NCG), n = 70.

Start	CG N = 33	NCG N = 37	p-Value*
1 month:T1			0.005
Lost to follow up	N = 1	N = 2
No progression, n (%)	31 (97)	26 (74)
Progression LRV ≥ 2%, n (%)	0	8 (23)
Exceeding LRV 10%, n (%)	1 (3)	1 (3)
2 month:T2			0.013
Lost to follow up	N = 2	N = 0
No progression, n (%)	29 (94)	25 (68)
Progression LRV ≥ 2%, n (%)	1 (3)	10 (27)
Exceeding LRV 10%, n (%)	1 (3)	2 (5)
3 month:T3			0.057
Lost to follow up	N = 1	N = 0
No progression, n (%)	27 (84)	22 (60)
Progression LRV ≥ 2%, n (%)	4 (13)	12 (32)
Exceeding LRV 10%, n (%)	1 (3)	3 (8)
6 month:T6			0.001
Lost to follow up	N = 1	N = 0
No progression, n (%)	27 (84)	16 (43)
Progression LRV ≥ 2%, n (%)	4 (13)	17 (46)
Exceeding LRV 10%, n (%)	1 (3)	4 (11)

*Significance level 0.05, bold values are significant, Fisher’s exact test

Table 3. Lymphedema relative volume (LRV) measured with water displacement method over six months in the compression group (CG), and noncompression group (NCG), (n = 70).

LRV %^a	CG^b	NCG^c	p-Value*
Diagnosis/start	N = 33	N = 37
Mean ± SD	4.4 ± 3.1	3.8 ± 3.5	0.456
1 month	N = 32	N = 35
Mean ± SD	2.4 ± 4.4	4.1 ± 3.1	0.080
Change from start
Mean diff (CI)	−1.9 (−3.1, −0.7)	0.3 (−0.7,1.3)	0.005
2 months	N = 31	N = 28
Mean ± SD	1.6 ± 3.5	4.7 ± 3.0	<0.001
Change from start
Mean diff (CI)	−2.6 (−3.9, −1.4)	−0.1 (−1.0,1.1)	0.001
3 months	N = 31	N = 25
Mean ± SD	1.8 ± 2.8	4.6 ± 3.3	0.001
Change from start
Mean diff (CI)	−2.6 (−3.7,−1.6)	−0.1 (−1.1,1.0)	0.001
6 months	N = 30	N = 22
Mean ± SD	0.7 ± 3.0	4.8 ± 4.2	<0.001
Change from start
Mean diff (CI)	−3.8 (−5.0,−2.5)	0.1 (−1.2,1.3)	<0.001

*Significance level 0.05, bold values are significant, T-test ^a Adjusted with +1.5%, if surgery in non-dominant side, and −1.5% if surgery in dominant side. ^bParticipants not included in analyses after the time when exceeded 10%. ^cParticipants not included in analyses after the time when progressed in LRV ≥2% from baseline or exceeded 10%.

Table 4. Local tissue water measured with Tissue Dielectric Constant (TDC) over 6 months in the compression group (CG), and noncompression group (NCG), (n = 70).

TDC ratio highest value, Same site followed	CG^a	NCG^b	p-Value*
Start	N = 33	N = 37
Median (min–max)	1.50 (1.09–1.96)	1.55 (1.05–2.15)	0.805
Mean ± SD	1.53 (0.21)	1.51 (0.30)
1 month	N = 30	N = 34
Median (min–max)	1.21 (0.86–1.98)	1.27 (0.91–1.89)	0.736
Mean ± SD	1.30 (0.28)	1.33 (0.28)
Change from start
Median diff (min–max)	−0.23 (−0.84–0.29)	−0.20 (−0.94–0.43)	0.609
2 months	N = 28	N = 27
Median (min–max)	1.13 (0.91–1.84)	1.25 (0.95–2.10)	0.074
Mean ± SD	1.23 (0.27)	1.35 (0.31)
Change from start
Median diff (min–max)	−0.29 (−0.81–0.28)	−0.16 (−0.94–0.94)	0.059
3 months	N = 30	N = 25
Median (min–max)	1.21 (0.90–1.77)	1.26 (1.00–1.91)	0.314
Mean ± SD	1.24 (0.22)	1.33 (0.29)
Change from start
Median diff (min–max)	−0.30 (−0.94–0.28)	−0.07 (−0.99–0.64)	0.053
6 months	N = 29	N = 20
Median (min–max)	1.12 (0.77–1.84)	1.25 (0.93–1.90)	0.211
Mean ± SD	1.23 (0.24)	1.34 (0.31)
Change from start
Median diff (min–max)	−0.28 (−1.04–0.30)	−0.10 (−1.00–0.40)	0.025
TDC ratio highest value, By any site followed	CG	NCG^a	p-Value*
Start	N = 33	N = 37
Median (min–max)	1.50 (1.09–1.96)	1.55 (1.05–2.15)	0.805
Mean ± SD	1.53 (0.21)	1.51 (0.30)
1 month	N = 32	N = 36
Median (min–max)	1.29 (1.00–1.98)	1.35 (1.04–1.89)	0.442
Mean ± SD	1.38 (0.26)	1.41 (0.24)
Change from start
Median diff (min–max)	−0.06 (−0.84–0.29)	−0.07 (−0.85–0.43)	0.685
2 months	N = 31	N = 28
Median (min–max)	1.29 (0.99–1.84)	1.37 (1.04–2.10)	0.595
Mean ± SD	1.35 (0.24)	1.40 (0.29)
Change from start
Median diff (min–max)	−0.16 (−0.56–0.28)	−0.09 (−0.94–0.94)	0.298
3 months	N = 31	N = 25
Median (min–max)	1.29 (1.05–1.77)	1.32 (1.01–2.01)	0.792
Mean ± SD	1.34 (0.19)	1.40 (0.31)
Change from start
Median diff (min–max)	−0.22 (−0.71–0.28)	−0.05 (−0.92–0.84)	0.149
6 months	N = 30	N = 21
Median (min–max)	1.26 (1.02–1.84)	1.25 (1.05–1.90)	0.781
Mean ± SD	1.34 (0.23)	1.37 (0.27)
Change from start
Median diff(min–max)	−0.20 (−0.62–0.30)	−0.02 (−1.00–0.40)	0.052

*Significance level 0.05, bold values are significant, Mann–Whitney U-test.

^aParticipants not included in analyses after the time when LRV exceeded 10%.

^bParticipants not included in analyses after the time when progressed in LRV ≥2% from baseline or exceeded 10%.

Data availability statement

The data that supports the findings of this study are available on request from the corresponding author, (KB).