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 rando mized 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