Date

2018-06-07

Protocol

Protocol changed

Item Changed

Intervention(s) planned

Previous Version

Study Settings (Sri Lanka): Pohlena, Walgama and Madihe suburbs, Galle District Snowball sampling method will be used to complete recruitment. Study design: This (LEDOXY-SL) trial is designed as a randomized, controlled, observer-, provider- and patient-blinded multicenter superiority trial with two parallel groups and a primary endpoint of change in grade of lymphedema at 24 months. The population will be stratified according to the Grade (Early Grade 1-3; Late Grade 4-6). Randomization will be performed as block randomization within each center in blocks of (N=4-10) for each of the groups (early and late). Intervention Intervention arm will receive doxycycline hyclate tablets 200mg/daily for six weeks (100mg/day for ages 14-18 years and body weight 40-50kg) Control arm will receive identical placebo tablets 100mg – 2 tablets/day for six weeks (1 tablet/day for ages 14-18 years and body weight 40-50kg) Standard lymphedema management protocols based on the use of simple measures of hygiene (regular washing with soap and water, skin and nail care), use of topical antibiotics or antifungal agents, exercise and footwear will be continued in both arms.

Next Version

Study Settings (Sri Lanka): Galle and Matara Districts; Snowball sampling method will be used to complete recruitment. Study design: This (LEDOXY-SL) trial is designed as a randomized, controlled, observer-, provider- and patient-blinded multicenter superiority trial with two parallel groups and a primary endpoint of change in grade of lymphedema at 24 months. The population will be stratified according to the Grade (Early Grade 1-3; Late Grade 4-6). Randomization will be performed as block randomization within each center in blocks of (N=4-10) for each of the groups (early and late). Intervention Intervention arm will receive doxycycline hyclate tablets 200mg/daily for six weeks (100mg/day for ages 14-18 years and body weight 40-50kg) Control arm will receive identical placebo tablets 100mg – 2 tablets/day for six weeks (1 tablet/day for ages 14-18 years and body weight 40-50kg) Standard lymphedema management protocols based on the use of simple measures of hygiene (regular washing with soap and water, skin and nail care), use of topical antibiotics or antifungal agents, exercise and footwear will be continued in both arms.