Table 1 Basic study data
From: Systematic review: conservative treatments for secondary lymphedema
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 |