Table 1.
Basic study data
| Study (Quality†) | Sample Size (Treatment + Control) | 1) Cause of SE 2) Definition of SE |
1) Time of SE Onset 2) Time of Tx initiation 3) Criteria to Start/stop Tx |
Other Inclusion/Exclusion Criteria |
|---|---|---|---|---|
| RCT | ||||
| Andersen 2000 [21] Denmark Fair (4) |
20 + 22 | 1) BCa Tx 2)≥ 200 ml volume or ≥ 2 cm circumference difference between arms |
1) After surgery 2)≥ 4 month post-BCa Tx 3) SE Dx/NR |
Exclusion: - bilateral BCa - SE Tx < 3 months - BCa recurrence - severe SE (volume difference > 30%) |
| Bertelli 1991 [22] Italy Fair (4) |
37 + 37 | 1) BCa Tx 2)> 10 cm and < 20 cm circumference difference between arms (mild SE) |
1) Limb circumference ≥ 25% compared to baseline 2) NS |
Inclusion: - no metastases or relapse - no Tx ≤ 6 months - no lymphangitis Exclusion: - wearing cardiac stimulator - currently receiving CT or RT |
| Bialoszewski 2009 [23] Poland Poor (3) |
12 + 12 | 1) Lower extremity SE post-leg lengthening surgery 2) Physical examination and radiographic images to Dx SE |
1) Following leg lengthening surgery 2) Post-surgery 3) Lower extremity SE/NR |
Inclusion: -age 15-40 years |
| Carati 2003 [11] Australia Good (8) |
37 + 27 | 1) BCa Tx 2)> 200 ml volume or ≥ 2 cm circumference difference between arms |
1) NR 2) NR 3) SE Dx/NR |
Inclusion: - female Exclusion: - co-morbidities present - significant change ≤ 3 months - unable to manipulate arm - primary SE |
| Damstra 2009 [24] Netherlands Good (6) |
18 + 18 | 1) BCa Tx 2) Moderate to severe SE (ISL definition) |
1) 3-50 month post-surgery 2)≥ 12 month post-surgery 3) SE Dx/NR |
Inclusion: -female -> 18 years -12 months post BCa Tx without reoccurrence Exclusion: -allergy to materials -systemic diseases -arterial/venous disease |
| Didem 2005 [25] Turkey Fair (5) |
27 + 26 | 1) BCa Tx 2) Arm circumference difference 2-5 cm |
1)> 1 year after surgery 2) 3 year post-surgery 3) SE Dx/NR |
Inclusion: - SE ≥ 1 year Exclusion: - psychiatric illness - pain in axillary region - cardiac disease - uncontrolled hypertension - malignancy |
| Dini 1998 [26] Italy Fair (5) |
40 + 40 | 1) BCa Tx 2) Arm circumference difference of 2-5 cm |
1)< 1 year 2)> 1 year after SE 3) SE Dx/difference in circumference > 10 cm in affected vs. unaffected limb/occurrence of harms |
Inclusion: - SE ≥ 1 year - no lymphangitis, no evidence of local or distant relapse, no other serious or psychiatric illness Exclusion: - prior SE therapy - bilateral breast surgery - bilateral axillary node dissection |
| Hayes 2009 [27] Australia Good (6) |
16 + 16 | 1) BCa Tx 2) Health professional diagnosis |
1) NR 2)≥ 6 month after BCa Tx 3) SE Dx/occurrence of harms |
Inclusion: -< 76 years - Unilateral BCa Tx ≥ 6 months ago - able to travel to clinic |
| Hou 2008 [28] China Poor (3) |
15 + 35 | 1) BCa Tx 2) NR |
1) NR 2)> 5 year post-surgery 3) SE Dx/NR |
Exclusion: - radiotherapy |
| Irdesel 2007 [29] Turkey Fair (5) |
10 + 11 |
1) BCa Tx 2) NR |
1) 3-60 month 2)> 4 month post-BCa surgery 3) SE Dx/NR |
Exclusion: -BCa operation < 4 months ago -recurrence or bilateral BCa -stage 4 BCa -elephantiasis -congestive heart failure -deep vein thrombosis -acute infection |
| Jahr 2008 [30] Germany Fair (5) |
11 + 10 | 1) BCa Tx 2) NR |
1) NR 2) ~4 year post-surgery 3) SE Dx/NR |
Inclusion: - age 18-80 years - living near study center -≥ 6 weeks since RT Exclusion: - Tx ≤ 3 months ago - acute inflammation - acute thrombosis - heart disease - electronic implant - pregnant - sensitivity to electric fields |
| Johansson 1998 [31] Sweden Fair (4) |
14 + 14 | 1) BCa Tx 2)> 10% difference in affected vs. unaffected arm |
1) Median 9-10.5 month 2) Median 9-10.5 month 3) SE Dx/NR |
Exclusion: - previous contralateral breast disease - comorbidity affecting swollen arm - treatment ≤ 6 months (except compression sleeve) - SE resolved during initial compression sleeve use |
| Kaviani 2006 [32] Iran Fair (5) |
4 + 4 | 1) BCa Tx 2)≥ 2 cm swelling in affected arm |
1) 3 month 2) SE ≥ 3 month 3) SE Dx/NR |
Inclusion: - no contraindications to laser Exclusion: - metastatic disease |
| Kessler 2003 [33] Switzerland Poor (3) |
11 + 12 | 1) Ankle surgery 2) Clinically diagnosed post-operative swelling |
1) NR 2) 2nd day post-surgery 3) Post-operative swelling/NR |
- Age: 18-75 year - good physical condition - no contraindications for lymph drainage |
| Kozanoglu 2009 [34] Turkey Poor (3) |
25 + 25 | 1) BCa Tx 2) Difference > 2 cm at 3/7 measurement points on limb |
1)> 3 month 2) SE > 3 month 3) SE Dx/NR |
Inclusion: - arm SE ≥ 3 months Exclusion: - metastases or ongoing RT - cellulitis - venous thrombosis - inflammatory disease - history of severe trauma - photosensitivity - medications that affect electrolyte balance - limitation in UE joints - physical therapy other than skin care - home exercises for SE in past 6 months |
| Lau 2009 [35] China Good (6) |
11 + 10 | 1) BCa Tx 2) Arm volume difference > 200 ml |
1) 22-60 month post-BCa 2) Post-BCa Tx 3) SE Dx/NR |
Inclusion: -≥ 18 years - unilateral mastectomy + CT or RT Exclusion: - metastases - history of arm trauma - kidney, heart, or lung disorder - medications that alter body fluids - primary SE of lower limb - decrease shoulder movement - cellulitis ≤ 3 months |
| Maiya 2008 [36] India Fair (5) |
10 + 10 | 1) BCa Tx 2)≥ 2 cm difference at any 2 points between affected and unaffected limbs |
1) NR 2) 3-6 week post-mastectomy 3) SE Dx/NR |
Inclusion: - mastectomy or RT completion Exclusion: - primary SE - limb infection |
| McKenzie 2003 [37] Canada Poor (3) |
7 + 7 | 1) BCa Tx 2) Circumference difference is > 2 cm and < 8 cm |
1) NR 2)> 6 month post-cancer Tx 3) SE Dx/NR |
Exclusion: - stage III SE - bilateral disease - medications that affect swelling |
| McNeely 2004 [38] Canada Good (6) |
22 + 20 | 1) BCa Tx 2)≥ 150 ml difference between affected and unaffected arms |
1) NR 2) NR 3) SE Dx/NR |
Inclusion: - no sleeve use < 4 months -≥ 6 months since SE T XExclusion: - new cancer D X- receiving RT or CT - infection in SE limb - contraindications to T X- uncontrolled hypertension - heart disease - renal insufficiency - venous thrombosis |
| Pilch 2009 [39] Poland Poor (3) |
17 + 9 + 11 + 20 |
1) BCa Tx 2) NR |
1) NR 2) NR 3) SE Dx/NR |
Inclusion: -age 39-80 years |
| Radakovic 1998 [40] Yugoslavia Poor (1) |
18 + 18 | 1) BCa Tx 2) NR |
1) NR 2) post-RT 3) SE Dx/NR |
Inclusion: - no metastases |
| Schmitz 2009 [41] U.S. (companion Schmitz [42]) Good (7) |
71 + 70 | 1) BCa Tx 2)≥ 10% volume or circumference difference between affected and unaffected arms |
1) NR 2) 1-15 year post-BCa 3) SE Dx/SE exacerbation or cancer recurrence |
Inclusion: - 1-15 years since BCa D X- no evidence of cancer - unilateral SE - BMI < 50 kg/m2 - not actively trying to lose weight - no medical conditions to limit exercise - no weight lifting ≤ 1 year - removal of at least one lymph node |
| Shaw 2007 [43] U.K. Fair (5) |
11 + 10 | 1) BCa Tx 2) Affected arm volume ≥ 15% than unaffected arm |
1) NR 2)≥ 12 month post-CT or RT 3) SE Dx/completion of therapeutic regimen |
Inclusion: - remission - BMI ≥ 25 kg/m2 |
| Shaw 2007 [44] U.K. Fair (5) |
19 + 17 + 15 | 1) BCa Tx 2) Affected arm volume ≥ 20% than unaffected arm |
1) NR 2)≥ 12 month post-cancer Tx 3) SE Dx/NR |
Inclusion: - remission |
| Sitzia 2002 [45] U.K. Fair (5) |
15 + 13 | 1) BCa Tx 2) Moderate or severe edema (≥ 20%) |
1) NR 2) NR 3) SE Dx/NR |
Inclusion: -≥ 18 years - no active disease - no Tx except support garment |
| Szuba 2002 [46] U.S. Fair (4) |
12 + 11 | 1) BCa Tx 2) Affected arm volume ≥ 20% than unaffected arm |
1) NR 2)≥ 3 month from BCa Tx 3) SE Dx/NR |
Inclusion: -≥ 12 week post T XExclusion: - active infection - recurrence - venous occlusion |
| Szuba 2002 [47]†† U.S. Fair (4) |
12 + 13 | 1) BCa Tx 2) NR |
1) NR 2) 1-12 month 3) SE Dx/NR |
Inclusion - CDT completed 1-12 months ago Exclusion: - active infection - recurrence - venous occlusion - bilateral SE |
| Tsai 2009 [48] China Good (6) |
20 + 21 | 1) BCa Tx 2) Affected arm circumference ≥ 2 cm than unaffected arm |
1)≥ 3 month post-BCa Tx 2) 4 week after control period 3) SE Dx/NR |
Inclusion: - unilateral SE ≥ 3 months Exclusion: - active cancer - use of diuretics or other SE influencing drugs - skin disease - decreased arm motion |
| Wilburn 2006 [49]†† U.S. Good (7) |
5 + 5 | 1) BCa Tx 2) Affected arm volume ≥ 20% than unaffected arm |
1) 34 ± 34 month 2) 0-5 month after SE onset 3) SE Dx/NR |
Exclusion: - bilateral SE - active cancer or infection - venous obstruction or active thrombophlebitis - pulmonary edema - congestive heart failure - history of pulmonary embolism - contraindications to Tx |
| Williams 2002 [50]†† U.K. Fair (4) |
15 + 16 | 1) BCa Tx 2)> 10% excess volume measured two times |
1)> 3 month 2)> 3 month 3) SE Dx/NR |
Exclusion: - active cancer - use of edema-influencing drugs |
| Observational | ||||
| Balzarini 1993 [51] Italy Good (8) |
50 + 100 | 1) BCa Tx 2)% difference between arms: ≤ 6.5% (mild), 6.5 to 13% (moderate), ≥ 13% (severe) |
1) IG: 3-52 month; CG: 5-57 month 2) NR 3) SE Dx/NR |
Exclusion: - Tx with regional RT |
| Berlin 1999 [50] Sweden Fair (6) |
28 + 8 +19 | 1) BCa Tx 2) Affected arm volume ≥ 100 ml than unaffected arm |
1) NR 2) NR 3) SE Dx/NR |
NR |
| Brambilla 2006 [53] Italy Good (8) |
50 + 15 | 1) SE due to Kaposi's sarcoma 2) Grade II SE according to ISL |
1) NR 2) NR 3) SE Dx/NR |
Inclusion: - SE below knee |
| Frischenschlager 1991 [54] Austria Fair (5) |
15 + 15 | 1) BCa Tx 2) NR |
1) ~5 year post-BCa Tx 2) NR 3) SE Dx/NR |
Inclusion: -female |
| Johansson 1999 [55] Sweden Fair (6) |
20 + 18 | 1) BCa Tx 2) Affected arm volume ≥ 10% than unaffected arm |
1) NR 2) NR 3) SE Dx/arm swelling resolution |
Exclusion: - previous contralateral breast disease - comorbidity affecting swollen arm - treatment ≤ 6 months (except compression sleeve) |
| Pinell 2007 [56] U.S. Good (7) |
16 + 56 | 1) BCa Tx 2) Affected arm circumference ≥ 2 cm than unaffected arm |
1) NR 2) NR 3) SE Dx/NR |
Inclusion: - referral to specific clinics |
BCa Breast Cancer; BMI Body Mass Index; CDT Complex Decongestive Therapy; CG control group; CT chemotherapy; Dx Diagnosis; IG intervention group; ISL International Society of Lymphology; mo: months; NR Not Reported; RT Radiation Therapy; RCT Randomized Control Trial; SE Secondary Lymphedema; Tx Treatment; UE: Upper extremity; wk week; yr year
†Rating (scale score)-RCT Jadad: poor (1-3), fair (4-5), good (6-8); Observational NOS: poor (0-3), fair (4-6), good (7-9)
††Crossover RCT (all other RCTs were randomized, parallel group)