Castro‐Sanchez 2011.

Methods	Parallel group randomised controlled trial.
Participants	Women aged 30 to 60, treated for breast cancer (stages not specified) including partial axillary dissection and adjuvant radiotherapy.
Interventions	Intervention group (n = 24) Elastic compression sleeve + manual lymph drainage 5 times a week for 6 months; Leduc method transthoracical and thoraco‐abdominal and manual lymph drainage of the arm. Control group (n = 24) Patient education
Outcomes	Primary outcome: Lymphoedema, defined as: between group mean difference in percentage upper arm volume difference (from circumference measurements) between affected vs non‐affected side (not reported). Secondary outcomes: Incident cases of lymphoedema, defined as > 2 cm increase in the circumferential measurements at 2 adjacent marked points in comparison with the corresponding contralateral arm. Volume of the arm. Body composition: fat‐free mass (g/kg/d), fat mass (kg), amount of extracellular water (l) as measured with bioimpedance measurements. Temperature of the back of the hand, anterior forearm and elbow. Health‐related quality of life (EORTC QLQ‐C30). Pain (10 point visual analogue scale). Functional Shoulder rating scale UCLA (composite score of self‐reported complaints and limitations, ROM measurements and strength measurements).
Follow up	8 months
Country, setting	Spain, 2 university hospitals
Year of conduct	2008 to 2009
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	A computer‐generated random number table was used.
Allocation concealment (selection bias)	Low risk	Randomisation cards were placed in opaque envelopes that were opened by a therapist who was not involved in baseline assessments.
Blinding of participants and personnel (performance bias) Objective outcomes	Unclear risk	Participants and personnel were not blinded for the intervention. The risk of contamination is unclear.
Blinding of participants and personnel (performance bias) Patient reported outcomes	Unclear risk	Participants and therapist were not blinded for the intervention. The risk of contamination is unclear.
Blinding of outcome assessment (detection bias) Measured outcomes	Low risk	Outcome assessor was blinded for group allocation.
Blinding of outcome assessment (detection bias) Patient reported outcomes	High risk	Self report for pain and HRQoL may be affected by participants' knowledge of group allocation.
Incomplete outcome data (attrition bias) Objective outcomes	Low risk	There is no loss to follow‐up.
Incomplete outcome data (attrition bias) Patient reported outcome	Low risk	There is no loss to follow‐up.
Selective reporting (reporting bias)	High risk	Reported incident cases with lymphoedema are based on a different criterion than defined in the methods section.
Other bias	High risk	At baseline, limb volume on the operated side was lower in the intervention group compared to the control group (307 mL vs 378 mL), no corrections were made to take this difference into account in the between‐group comparison of volume at follow‐up. At baseline, the intervention group had lower scores than the control group for the EORTC QLQ‐C30 domains of: Physical functioning (114 vs 123) Role functioning (88 vs 96) Social functioning (120 vs 126) Global health (73 vs 87) Constipation (4 vs 11) Diarrhoea (44 vs 53) Financial difficulties (5 vs 14) No corrections were made to take these differences into account. The intervention group had more contacts with a therapist, which may reinforce other behaviour such as compliance to exercises and self‐care measures.