| Study ID | Methods | Participants | Interventions | Outcomes | Notes |
| Ahmed 2006
USA | 6 month parallel group trial
Blocked randomisation procedure with random number table and stratifying according to age and body fat
2 groups:
(1) weight training twice a week (n=23)
(2) control ‐ no weight training (n=23)
Withdrawn/excluded:
Not clear. It appears as though the analyses were only undertaken on women who had axillary dissection but the numbers vary from 22 to 23 in control group. Dropouts from original trial: (1) 4/42 (10%) ‐ 2 breast cancer recurrence, 2 personal reasons; (2) 3/43 7% ‐ 2 breast cancer recurrence, 1 personal reasons | Recruitment was between October 2001 and June 2002.
Breast cancer survivors living in the greater Minneapolis‐Saint Paul area.
All appear to have had axillary node dissection.
Only a proportion of the group had lymphoedema (measured by arm circumference measurements, self report of diagnosis and self report of symptoms)
(1)
Age: 52.3 (7.7) yrs
Self report of lymph diagnosis: 7 (30.4%)
Self report of lymph symptoms: 10 (43.4%)
Lymph by arm circ: 4 (17.4%)
Time since br ca diagnosis: 22.3 (7 to 43) mths
(2)
Age: 51.7 (7.5) yrs
Self report of lymph diagnosis: 6 (26.1%)
Self report of lymph symptoms: 7 (30.4%)
Lymph by arm circ: 4 (17.4%)
Time since br ca diagnosis: 21.9 (11 to 57) mths | (1) Weight training twice a week for 6 months for approx 1 hour
(2) Control ‐ not clearly described. It appears they had no weight training. | ‐ Change in arm circumference
‐ Incidence of lymphoedema at 6 months (measured by arm circumference or self report) | Only a proportion of the participants had lymphoedema at baseline (13%).
Trial does not use limb volume as the method of assessing change in size. |
| Bertelli 1991
Italy | 6 month parallel group trial
Method of randomisation not stated.
Two groups:
Group 1: Hosiery alone (n=37)
Group 2: Hosiery + electrically stimulated drainage (ESD) (n=37)
Withdrawn/excluded:
14/74
Group 1: 6/37
2 refused treatment
4 lost to follow‐up
Group 2: 8/37
2 refused treatment
1 had lymphangitis;
2 lost to follow‐up;
3 withdrawn because oedema worsened. | All had unilateral oedema of the upper limb following trt for breast ca.
All had axillary node dissection.
All had Delta value >10 cms <20 cms
Group 1:
Median (range)
Age = 64 (45‐77)
No. (%)
Radical mast = 17 (46)
Mod. radical mast = 12 (32.4)
Quandrantectomy = 8 (21.6)
Radiotherapy = 14 (37.8)
Chemotherapy = 10 (27)
Prev. trt for l'oedema = 19 (51.3)
Prev. lymphangitis = 12 (32.4)
Group 2:
Median (range)
age = 64 (48‐78)
No. (%)
Radical mast = 10 (27)
Mod. radical mast = 18 (48.7)
Quandrantectomy = 9 (24.3)
Radiotherapy = 14 (37.8)
Chemotherapy = 6 (16.2)
Prev. trt for l'oedema = 16 (43.2)
Prev. lymphangitis = 12 (32.4) | Group 1:
Compression sleeve worn for 6 hours a day
Group 2:
Compression sleeve worn for 6 hours a day
ESD 10x30 min over 2 weeks; gap of 5 weeks then same cycle repeated.
Both groups received advice of skin care and prevention of infection. | ‐ Change in size estimated by taking circumference measurements at 7 points along both swollen & normal limb, establishing the difference between them, and totalling these. the sum of the differences between swollen and normal were designated "Delta".
Response was determined by the %
change in the final Delta value compared to baseline. | Trial is long enough but does not use limb volume as the method of assessing change in size. |
| Didem 2005
Turkey | 4 week trial.
Randomisation by unmarked envelopes.
2 groups:
(1) Complex decongestive physiotherapy (CDP) (n=27)
(2) Standard physiotherapy (SP) (n=26)
Withdrawn/excluded:
There appear to be no withdrawals after randomisation. Prior to randomisation: 1/28 from group 1 withdrew because of br ca recurrence; 2/28 withdrew from group 2 because of arm infection. | All had developed lymphoedema after the first year from surgery (average duration of lymph at time of treatment was 3 years).
60% had moderate lymph; 40% had mild lymph (but this varied by randomised group (there are errors in the publication).
All patients had undergone axillary dissection with a range of 2 ‐ 35 nodes removed.
(1)
Mild lymph: 7.4%
Moderate lymph: 92.3%
Mild: age 53.1 (3.1) yrs
Moderate: age 61.3 (7.2) yrs
Mild: weight 66.3 (9.8) kg
Moderate: weight 73.9 (13.2) kg
Mild: history of cellulites 8.3%
Moderate: history of cellulites 20%
(2)
Mild lymph: 73.1%
Moderate lymph: 26.9%
Mild: age 54.7 (12.1) yrs
Moderate: age 63.6 (0.7) yrs
Mild: weight 64.7 (11.4) kg
Moderate: weight 71.5 (6.8) kg
Mild: history of cellulites 0%
Moderate: history of cellulites 29.4% | Group 1:
CDP: lymph drainage, multilayer compression bandage, elevation, remedial exercises and skin care
Group 2:
SP: bandage, elevation, head‐neck and shoulder exercises and skin care
All patients had their physiotherapy once a day, 3 days a week for 4 weeks and they were blind to the intervention. | ‐ Edema of the arm (assessed by circumference measurements)
‐ Volume of the arm (assessed with water displacement)
‐ Shoulder mobility (assessed by extension‐flexion, abduction‐adduction, external rotation) | Trial does not follow the patients for long enough. The authors state that they plan to report on long term follow up (6 months, 12 months and 24 months). The authors were contacted but have not submitted their longer term follow up. |
| Dini 1998
Italy | 9 week parallel group trial
Randomisation achieved by phone call to Clinical trials office
Two groups
Group 1:
Pneumatic Compression Therapy [PCT] (n=40)
Group 2:
No PCT (n=40)
Withdrawn/excluded:
13 in all
Group 1 no. 8
2/40 recur ca.
3/40 refused PCT
3/40 lost to follow‐up
Group 2 no. 5
2/40 recurrence of cancer
3/40 lost to follow‐up | All particiants had unilateral upper limb oedema following "radical" breast surgery + axillary node dissection for stage I‐III breast ca.
All had "Delta" value of > 10cms.
Group 1:
Mean (+/‐)
Age = 62 (12)
duration of oed. (days) = 155 (38)
Baseline Delta = 16.6 (6.7)
No. (%)
Radical Mast = 4 (10)
Mod. radical Mast. = 20 (50)
Conservative surg = 16 (40)
Radiotherapy = 21 (52.5)
Adj. Chemo = 11 (27.5)
Prev. lymphangitis = 6 (15)
Group 2:
Mean (+/‐)
Age = 62 (10)
duration of oed. (days) = 236 (59)
Baseline Delta = 14.9 (4.6)
No. (%)
Radical Mast = 9 (22.5)
Mod. radical Mast. = 23 (57.5)
Conservative surg = 8 (20)
Radiotherapy = 14 (35)
Adj. Chemo = 8 (20)
Prev. lymphangitis = 10 (25) | Group 1:
Pneumatic compression (60mmHg) 2hr sessions 5 days a week for 2 wks; gap of 5 weeks then repeat of same schedule as before.
Group 2:
No treatment
Both groups received advice on care of skin & prevention of infection.
No other physical treatments were allowed. | ‐ Change in size estimated by taking circumference measurements at 7 points along both swollen & normal limb, establishing the difference between them, and totalling these. the sum of the differences between swollen and normal were designated "Delta".
Response was determined by the % change in the final Delta value compared to baseline. | Trial does not follow patients up for long enough (i.e. at least 6 months).
Also, does not use limb volume as the method of assessing change in size |
| Irdesel 2007
Turkey | 6 month parallel group trial
Randomisation method not clear from abstract
2 groups:
(1) exercises and compression garment, n=10
(2) exercises alone, n=9
Withdrawn/excluded: Not clear from abstract | Details not clear from abstract | Group 1:
Exercises and compression garment
Group 2:
Exercises alone | ‐ Reduction in lymphoedema volume (assessed by measurement of arm circumference)
‐ Improvement in shoulder range of motion
‐ Symptoms such as pain and tender points | Trial does not use limb volume as the method of assessing change in size |
| Johansson 1998
Sweden | 4 week parallel group trial in 2 parts
Part I all subjects received same treatment
Part II randomised to 2 different interventions
Method of randomisation not stated
2 groups
Group 1:
Manual Lymph Drainage [MLD] (n=14)
Group 2:
Sequential Pneumatic Compression [SPC] (n=14)
Withdrawn/excluded
End of Part 1 ‐ 1/28 because oedema resolved
Part 2 ‐ 4 in all, 2 from each group.
2 patients had recurrent cancer;
1 patient had erysipelas;
1 patient could not attend for follow‐up | Recruitment was over a 2.5 year period.
Patients attending Dept. of physical therapy with unilateral breast ca‐related upper limb lymphoedema.
All had axillary node dissection.
Lymphoedema defined as excess limb vol >10%
Group 1:
Median (q1‐q3)
Age = 64 (52.5‐69.5)
Duration of oedema (months) 14.0 (3.0‐76.5)
No.
Partial mastectomy = 1
Mastectomy = 11
Radiotherapy = 10
Group 2:
Median (q1‐q3)
Age = 57.5 (47.5‐69.5)
Duration of oedema (months) 6.0 (2.3‐68.3)
No.
Partial mastectomy = 2
Mastectomy = 10
Radiotherapy = 8 | All participants began with 2 weeks of wearing a compression sleeve
3rd week
Group 1:
Received MLD for 45 mins/day; 5/7 for 2 weeks at same time each day
Group 2 :
Received sequential pneumatic compression therapy with the Lympha‐Press 2hrs/day (40‐60 mmHg)
Both groups continued to wear a compression sleeve. | ‐ % reduction in excess limb volume
measured by water displacement
‐ Body weight
‐ Passive mobility of shoulder measured by goniometer
‐ Isometric muscle strength measured by dynamometer
‐ Patient's subjective assessment of: pain, heaviness, tension, function, paresthesia. | Trial does not follow patients up for long enough (i.e. at least 6 months) |
| Johansson 2005
Sweden | 5 day crossover trial.
Randomisation method not stated.
2 groups:
(1) arm exercises with compression sleeve (n=16 first)
(2) arm exercises without compression sleeve (n=15 first)
Withdrawn/excluded:
4/42 withdrew because of personal reasons; 7/42 did not reach the eligibility criteria of at least a 10% greater arm volume in the affected arm (after randomisation) | Recruitment was in September 2002.
Patients from the physiotherapists registry of lymphoedema patients at the Physiotherapy Department of Vaxjo Central Hospital and the Lymphedema Unit, Lund University Hospital, Lund Sweden.
Lymphoedema defined as 10‐40% greater arm volume in affected arm.
Demographic characteristics not given separately by group.
Age: 55.3 (7.3) yrs
Surgery: partial n=13; mastectomy n=18
No of axillary nodes dissected: 13.3 (5.2)
Duration of edema: 66.7 (51.7) months
BMI: 25.9 (3.2) | All participants wore a compression sleeve for 2 weeks before the trial.
Trial was over 5 days:
Training exercise on day 1, assessments before, immediately after and 24 hours after.
Then training exercise on day 3 with assessments before, immediately after and 24 hours after. The participants appear to be crossed over to the alternate treatment for the 2nd training session. | ‐ Arm volume (measured by water displacement method and multiple frequency bioelectrical impedance analysis)
‐ Borg's scale for perceived exertion | Trial does not follow patients up for long enough (at least 6 months) |
| McKenzie 2003
Canada | 8 week parallel group trial.
Randomisation method not stated.
2 groups:
(1) Exercise, n=7
(2) Control (no exercise), n=7
Withdrawn/excluded:
There did not appear to be any withdrawals from the trial. | Recruitment details not provided.
Lymphoedema defined as unilateral and between 2 and 8 cm on at least one measurement point.
Group 1:
Age: 56.4 (10.4) yrs
Weight: 77.8 (20.6) kg
BMI: 29.1 (6.6)
Group 2:
Age: 56.9 (8.2) yrs
Weight: 67.3 (9.1) kg
BMI; 25.6 (3.3) | A compression sleeve was used daily by all participants.
(1) 8 week exercise program (resistance training 3 times per week plus aerobic exercise using a Monark Rehab Trainer arm ergometer)
(2) No specific exercise instruction | ‐ Arm circumference
‐ Arm volume (assessed by water displacement)
‐ SF36 | Trial does not follow patients for long enough (at least 6 months). |
| McNeely 2004
Canada | 4 week parallel group trial.
Randomisation by computer generated code.
2 groups:
(1) MLD plus multi‐layered compression bandaging, n=25
(2) Compression bandaging alone, n=25
Withdrawn/excluded:
5/50 did not complete the study. 2 withdrew because of adverse events (1 from group 1 because of a skin reaction to bandaging, 1 from group 2 because of elbow discomfort from bandaging), 3 from group 2 withdrew (1 because of personal reasons, 2 because of dissatisfaction with treatment response). 1 additional participant from group 1 withdrew from the assessment of arm volume because of an error in measurement. | Recruitment from November 2000 to December 2001 from Cross Cancer Institute in Edmonton, Canada.
Lymphoedema defined as a minimum of a 150ml difference between affected and unaffected arms.
Group 1:
Age: 58 (13) yrs
No lymph nodes removed: 12 (6)
Type of lymph: mild 31%, moderate 52%, severe 17%
Early lymp 35%
Chronic lymph 65%
Group 2:
Age: 63 (13) yrs
No lymph nodes removed: 10 (5)
Type of lymp: mild 24%, moderate 52%, severe 24%
Early lymph: 48%
Chronic lymph: 52% | All participants had standard education on proper arm and skin care.
(1) 45 minutes of daily MLD 5 times per week (Vodder method) plus short stretch bandaging
(2) Short stretch bandaging alone | ‐ Reduction in arm lymphoedema volume (assessed by water displacement volumetry and arm circumference)
This outcome was assessed by independent assessors blinded to subject treatment assignment. | Trial does not follow patients for long enough (at least 6 months). |
| Sitzia 2002
UK | 2 week parallel group trial .
Randomisation by computer‐generated code managed by non‐clinical researcher.
Two groups
Group 1: MLD (n=15);
Group 2: SLD (n=13).
Withdrawn/excluded:
1 pt from Group 2 only treated for 5 days.
No adverse events | Recruited from all new referrals to l'oedema clinic from Jan '96 to June '99.
All were female, with unilateral upper limb oedema following trt for breast ca.
95 referred;
40 fulfilled inclusion criteria;
12 declined;
28 consented.
Group 1
Mean (SD):
age = 68 (10.8)
% Excess Volume at start = 68.3 (39.5)
No. (%)
Mastectomy & axillary clearance = 11(73)
Lumpectomy & axillary clearance = 2 (13)
Fine needle aspiration = 1 (7)
No surgery = 1 (7)
Radiotherapy = 13 (87)
Group 2
Mean (SD):
age = 75 (10.2)
% Excess Volume at start = 58.5 (26.7)
No. (%)
Mastectomy & axillary clearance = 11(85)
Lumpectomy & axillary clearance = 2 (15)
Fine needle aspiration = 0
No surgery = 0
Radiotherapy = 10 (77) | Group 1:
MLD given for 40‐80 mins 5 days a week for 2 weeks;
Group 2:
SLD performed by same therapist 20 mins 5 days a week for 2 weeks
Following massage limbs in both groups were bandaged using multi‐layer technique | ‐ % Reduction in excess limb volume at 2 weeks. ‐ Limb volume calculated from surface measurements. | Trial does not follow patients up for long enough (i.e. for at least 6 months) |
| Szuba 2002
USA | 6 month crossover trial.
Randomisation method not stated.
First phase of study: 10 day RCT with 30 day follow up of IPC + DLT vs DLT.
Second phase of study: 2 month crossover RCT with 6 month follow up of IPC + DLT vs DLT.
2 groups:
(1) Intermittent pneumatic compression (IPC) + decongestive lymphatic therapy (DLT) first, DLT alone second, n=13
(2) DLT alone first, IPC + DLT second, n=12
(Each participant had both treatments in a random order)
Excluded/withdrew:
2/27 did not complete the study. After the 2 month RCT, 20/25 continued using IPC and 19 were still using IPC at end of follow up. | Recruitment from patients presenting to Stanford Centre for Lymphatic and Venous Disorders with stable treated lymphoedema.
Lymphoedema was defined as presence of an increase of at least 20% in the volume of the swollen limb compared to the volume of the contralateral arm.
Demographic data not reported by group.
All participants:
Age: 65.9 (43 to 81) yrs
Average duration of lymph: 60 (3 to 480) mths
Average time from surgery: 113.7 mths | All participants had completed an initial course of intensive DLT btwn 1 and 12 months prior to enrolment.
(1) IPC, 1 hr daily administered at home + daily DLT (MLD for 30 to 60 minutes (Vodder type), compressive bandaging and decongestive exercises
(2) Daily DLT alone | ‐ Arm volume (assessed by water displacement method)
‐ Tissue tonometry (to assess elasticity of the skin)
‐ Goniometry (to measure joint mobility) | All participants were free to continue with IPC after 2 months of treatment, so assessment at 6 month follow up was not of randomised groups. |
| Wilburn 2006
USA | 6 week crossover trial.
Randomisation method not stated.
2 groups:
(1) Flexitouch (mechanical device which simulates MLD) first, massage second, n=5
(2) Massage first, Flexitouch second, n=5
All participants used a compression garment daily
Withdrawn/excluded:
There do not appear to be any withdrawals. | Recruitment from patients presenting to Stanford Centre for Lymphatic and Venous Disorders.
Lymphoedema defined as an increase of at least 10% in the measured volume of the affected arm when compared with the contralateral limb.
Demographic data not reported by group.
All participants:
Age: 60 (7) yrs
Duration since initial cancer Rx: 103 (87) mths
Onset of arm swelling prior to enrolment: 34 (34) mths
Weight: 75 (12) kg | (1) Flexitouch self administered for 1 hour daily for 14 consecutive days
(2) Self administered massage for 1 hour daily for 14 consecutive days
1 week washout period between treatments where the use of the compression garment only was permitted. | ‐ Limb volume (assessed by surface measurements and a simplified formula for a ftrustum)
‐ SF36 | Trial does not follow patients up for long enough (i.e. for at least 6 months). |
| Williams 2002
UK | 9 week crossover trial.
Method of randomisation not stated
Two trial groups
Group 1: MLD first self‐administered massage [SAM] second (no=15)
Group 2: SAM first, MLD second (n=16)
Withdrawn/excluded:
2/31 both from Group 2, 1 had pulmonary embolus, 1 herpes zoster in affected area. | All patients had unilateral upper limb lymphoedema as a result of trt for breast ca.
All had excess limb vol > 10%, 2 consecutive stable arm measurements, evidence of trunk oedema.
Group 1:
Mean (SD calculated from SE)
Age = 59.7 (8.1)
Baseline % Ex Vol = 30.1 (18.9)
Duration of oedema (months) = 82.5 (56.9)
Weight (kg) = 70.8 (12.0)
No. (%)
Local excision = 9 (60)
Mastectomy = 6 (40)
Axillary sampling = 8 (53)
Axillary clearance = 6 (40)
no surgery = 1 (7%)
Radiotherapy to breast = 12 (80)
Radiotherapy to axilla = 10 (67)
Chemo = 3 (20)
Tamoxifen = (7 (47)
Group 2:
Mean (SD calculated from SE)
Age = 59.3 (9.6)
Baseline % Ex Vol = 39.5 (17.6)
Duration of oedema (months) = 118.4 (88)
Weight (kg) = 72.7 (13.6)
No. (%)
Local excision = 8 (50)
Mastectomy = 8 (50)
Axillary sampling = 12 (75)
Axillary clearance = 4 (25)
no surgery = 0
Radiotherapy to breast = 14 (88)
Radiotherapy to axilla = 11 (69)
Chemo = 6 (38)
Tamoxifen = 7 (19) | Group 1:
15 x 1 hour sessions of MLD over 3 weeks, performed by therapists followed by 6 weeks washout period of no trt, then 3 weeks of 20 mins daily SAM.
Group 2:
3 weeks of 20 mins daily SAM. followed by 6 weeks washout period of no trt, then 15 x 1 hour sessions of MLD over 3 weeks, performed by therapists.
Both groups wore compression sleeves during the day throughout the study. | Changes in excess limb volume. Volume measured electronically by Perometer and also calculated from surface measurements taken by hand.
Changes in caliper creep on right and left axillary folds, measured by modified Harpenden skin calipers.
Changes in dermal depth on affected side, measured by skin ultrasound.
Changes in quality of life measured by EORTC QLQ C30
Changes in movement & function using validated assessment tool.
Subjective assessment of changes in altered sensation.
Change in arm and trunk swelling assessed subjectively by "pinch test".
Subjective assessment of change in areas of fibrosis.
Record of infection.
Patients perceptions of treatment based on diaries and interviews. | Trial does not follow patients up for long enough (i.e. for at least 6 months) |
| Adj. Chemo:
EORTC QLQ C30:
CDP:
DLT:
ESD:
IPC:
L'oedema:
Mast:
Mins:
Oed:
Plt:
q:
SAM:
SD:
SE:
SLD:
SP
Surg:
Trt:
V: | Adjuvant chemotherapy
European organisation for Research and Treatment of Cancer Core 30 Quality of Life Questionnaire
Complex decongestive physiotherapy
Decongestive lymphatic therapy
Electrically stimulated drainage
Intermittent pneumatic compression
Lymphoedema
Mastectomy
Minutes
Oedema
P
Quartile
Self administered massage
Standard deviation
Standard error
Simple lymph drainage
Standard physiotherapy
Surgery
Treatment
Volume | | | | |
