Table 2.

Trial inclusion and exclusion criteria

Inclusion criteria	Exclusion criteria
Age ≥18 years	Males
Histologically confirmed invasive or non-invasive primary breast cancer scheduled for surgical excision of breast cancer	Women having immediate reconstructive surgery
Considered high risk of developing shoulder problems after surgery defined by one or more of the following: Planned axillary node clearance Planned radiotherapy to the axilla and/or supraclavicular* Existing shoulder problems (based on PROSPER screening criteria)	Women having SLNB, with or without breast surgery, unless they fulfil other high-risk criteria
Obesity defined as body mass index >30	Women having bilateral breast surgery
Any subsequent axillary surgery related to primary surgery, eg, axillary lymph node clearance conducted after SLNB	Evidence of metastatic disease at time of recruitment
Able to provide written informed consent
Willing and able to comply with the protocol

*Includes women informed of need for radiotherapy to the axilla and/or supraclavicular within 6 weeks of surgery, thus potential late entry to the trial is allowed in this setting.

PROSPER, PRevention Of Shoulder ProblEms tRial; SLNB, sentinel lymph node biopsy.