Abstract
e14647 Background: Frail individuals with declining performance status, and people with very advanced cancer, are frequently excluded from clinical trials, making it difficult to test new therapeutics intended to improve longevity or quality of life (QOL) in the advanced cancer and palliative care settings. Is it feasible to conduct these trials at home and adhere to Good Clinical Practice (GCP)? Methods: KLT-PANC-001 is a 2:1 randomized study of gemcitabine (G) with or without Kanglaite (K) injection (extract of coix seed, a traditional Chinese medicine) in metastatic pancreatic cancer. Each 4-week cycle requires K infusions over >2 hours, 5 days weekly for 3 weeks (then 1 week off); G is infused in a clinic-based facility on days 1, 8, 15. After establishing infusion safety, K is administered in clinic or at home by GCP-trained nurses. Laboratory data are collected with standardized kits. Home patient-reported QOL and symptoms (PROs) are collected using tablet computers assigned to each patient. Results: 22 participants have been enrolled with metastatic pancreatic cancer. For 7 participants randomized to G, all infusions were received as intended except for protocol-related exclusions. 15 participants were randomized to K+G and 14 chose home infusions. Despite the intensive KLT treatment program, compliance with scheduled doses remained high and comparable between clinic and home settings; see Table: K+G compliance with planned doses (% of scheduled infusions administered on time), by cycle week, for all treatment cycles. Focusing on week 3 of the treatment cycle (most burdensome) 81-100% of intended pain PROs were collected in clinic, 86-92% at home. Conclusions: Home-based infusions by GCP-trained staff and data collection using patient-specific tablet computers can facilitate intensive clinical trials intended to enroll ill patients with advanced cancer. Protocol compliance with scheduled infusions and data collection was high. Treatment cycle week Proportion received in clinic (doses scheduled) Proportion received in home (doses scheduled) Week 1 94% (59) 94% (149) Week 2 87% (39) 91% (149) Week 3 87% (71) 92% (108) Author Disclosure Employment or Leadership Position Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Kanglaite, Inc. Kanglaite, Inc.
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