Compression Therapy for HIV-Associated Kaposi Sarcoma Leg Lymphedema: Results of the Kenyan Improvised Compression for Kaposi Sarcoma Randomized Controlled Trial

Abstract

Purpose: Evaluate the effectiveness of compression while receiving chemotherapy compared with chemotherapy alone in the treatment of HIV-associated Kaposi sarcoma (KS) lymphedema.

Methods: A randomized controlled trial was conducted in a single oncology clinic in western Kenya (NCT03404297). A computer-generated randomization schedule was used to allocate treatment arms. Randomized block design was used for stratification by lymphedema stage. Participants were HIV positive adults age ≥ 18 years on antiretroviral therapy with biopsy-proven KS associated with leg lymphedema and being initiated on chemotherapy. The intervention was 10 weeks of weekly clinic-based application of two-component paste compression bandages. The primary outcome was change in the Lower Extremity Lymphedema Index (LELI) score from week 0 to week 14. The secondary outcomes were change in the Lymphedema Quality of Life measure (LYMQOL) and change in the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 score from week 0 to week 14. Blinded outcome assessments were conducted.

Results: Of 30 participants randomly assigned, 25 eligible patients (chemotherapy [control], n = 13; compression plus chemotherapy [intervention], n = 12) returned at week 14. Change in LELI, LYMQOL, and EORTC QLQ-C30 scores between week 14 and week 0 did not significantly differ by arm. The mean (standard deviation) change in LELI score was -25.9 (34.6) for the control arm compared with -13.3 (29.5) for the intervention arm, P = .340. The difference (95% CI) in the change in LELI score was -12.6 (-39.3 to 14.1).

Conclusion: Future studies evaluating a 14-week change in LELI for KS lymphedema should assume a standard deviation of approximately 30. Lessons learned from this pilot trial should inform the development of a larger, multicenter trial to evaluate the effectiveness of compression for KS lymphedema.

Conflict of interest statement

Rakhi KarwaConsulting or Advisory Role: Abbott Laboratories, Direct Relief, Becton Dickinson Naftali BusakhalaResearch Funding: Lilly (Inst) Toby MaurerEmployment: Maurer Dermatology AssociatesLeadership: Maurer Dermatology AssociatesStock and Other Ownership Interests: Maurer Dermatology AssociatesHonoraria: Symposia MedicusConsulting or Advisory Role: Medweb Sonak D. PastakiaEmployment: Abbott Laboratories, Becton DickinsonConsulting or Advisory Role: Abbott Laboratories, Becton DickinsonNo other potential conflicts of interest were reported.

Figures

FIG 1

The two-component paste compression bandage system includes (A) an inner layer bandage composed of zinc oxide–impregnated gauze, together with (B) an outer layer of elastic crepe.

FIG 2

CONSORT flow diagram.

FIG 3

LELI score through week 14 by arm. A higher score indicates a higher severity of lymphedema. LELI, Lower Extremity Lymphedema Index.

FIG 4

(A) LYMQOL function, (B) appearance, (C) symptoms, and (D) mood scores through week 14 by arm. A higher score indicates a lower QOL rating. LYMQOL, Lymphedema Quality of Life.

FIG 5

EORTC CLC-Q30 score through week 14 by arm. A higher score indicates a higher QOL rating. EORTC, European Organisation for Research and Treatment of Cancer.