This study is designed to investigate the response of unilateral upper extremity (arm) lymphedema, during pharmacologic treatment of lymphedema with oral placebo and oral acebilustat. Participants will receive "study drug" (Acebilustat or placebo), for 9 months. For 3 of these months, the participant will receive placebo; for 6 of these months, the participant will receive active ingredient, acebilustat. The study is blinded which means that the participant will not be told which study pill they are taking.
To enter this study, participants will have to meet requirements that will be evaluated during screening, Visit 1. If eligible, and if they choose to continue, Visit 2, treatment start, will take place 2-7 days later. Study visits are every (approximately) 90 days. Physical exam, including limb measurements and skin measurements (with tape measure and dermal ultrasound) are performed. Phlebotomy for research samples and clinical labs will be performed at study start and end of study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
By mouth, once a day, 100 mg capsule
Placebo to match acebilustat by mouth, once a day
Stanford University
Palo Alto, California, United States
Change in cutaneous thickness in the affected upper extremity, as measured by skin calipers.
Cutaneous thickness will be measured by skin calipers at three designated locations in the affected upper extremity.
Time frame: Comparison of the measurement of week 0 to week 12 and of week 12 to week 36
Change in cutaneous dimensions and architecture in the affected upper extremity, as measured by ultrasound
Cutaneous measurements will be derived from serial ultrasonographic examination at three designated locations in the affected upper extremity using a Terason 3200T device
Time frame: Comparison of the measurement of week 0 to week 12 and of week 12 to week 36
Change in the volume of the affected upper extremity.
Volume changes in the affected upper extremity will be calculated through circumferential measurements of the limb and quantitated with the truncated cone approximation.
Time frame: Comparison of the measurement of week 0 to week 12 and of week 12 to week 36.
Change in LymQoL score
Change in the LymQoL (Lymphedema Quality of Life) questionnaire score will be used to assess the impact of lymphedema on patients' quality of life. The LymQoL is a validated, disease-specific tool measuring physical, psychological, appearance, and functional domains (range 0-100; higher scores indicate worse QoL).
Time frame: Comparison of the measurement of week 0 to week 12 and of week 12 to week 36.
Change in LymVAS score
Change in the LymVAS (Lymphedema Visual Analog Scale) questionnaire score will be used to assess patient-perceived lymphedema severity (0 = none, 10 = worst).
Time frame: Comparison of the measurement of week 0 to week 12 and of week 12 to week 36.
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