Randomized controlled trial to evaluate locally sourced two-component compression bandages for HIV-associated Kaposi sarcoma leg lymphedema in western Kenya: The Kenyan Improvised Compression for Kaposi Sarcoma (KICKS) study protocol

Abstract

Background: HIV-associated Kaposi sarcoma (KS), among the most frequent cancers seen in sub-Saharan Africa, is associated with a high prevalence of lymphedema. Lymphedema causes progressive functional impairment marked by swelling, physical discomfort, disfiguring changes, skin hardening from fibrosis, poor wound healing, and recurrent skin infection. While compression therapy is considered a major component of lymphedema management, this intervention has never been evaluated in HIV-associated KS lymphedema. Methods/design: The Kenyan Improvised Compression for Kaposi Sarcoma (KICKS) study is a randomized, controlled trial. Due to variable lymphedema stage, we will use block randomization with a 1:1 allocation to assign participants to one of two groups: “Immediate compression” or “Delayed compression.” Those randomized to “Immediate compression” intervention arm will receive weekly two-component compression bandages while receiving chemotherapy, whereas those in the “Delayed compression” control arm will be followed during chemotherapy and then receive compression after chemotherapy is completed. The primary outcome is change in Lower Extremity Lymphedema Index from enrollment at Week 0 to blinded outcome assessment at Week 14 between intervention and control arms. Secondary outcomes are change in leg lymphedema-specific quality of life (LYMQOL) and change in overall health quality of life in cancer (EORTC QLQ C30). Discussion: This represents the first study in sub-Saharan Africa to assess a lymphedema-directed intervention for KS, and the intervention—locally sourced two-component compression bandages—is affordable and available. Thus, the KICKS study is an important step towards developing an evidence-based path for regionally relevant management of HIV-associated KS lymphedema. Trial registration: This trial was registered at ClinicalTrials.gov on January 19, 2018: identifier NCT03404297. Keywords: Kaposi sarcoma, Lymphedema, Compression, Unna boot, Paste bandage, Randomized controlled trial