Post-HSCT care at home: Can maintaining the patient’s microbiome prevent GVHD, improve other outcomes, decrease costs, and reduce the risk of COVID-19?
Can receiving all posttransplant care at home benefit patients undergoing hematopoietic stem cell transplant (HSCT)? Researchers are conducting phase 2 trials to find out.
Dr. Sung outlined the process of receiving post-HSCT care at home and discussed Duke's clinical trials assessing the impact of home care on costs, quality of life, the microbiome, and graft-versus-host disease (GVHD).
Dr. Sung also discussed another Duke trial investigating whether a probiotic can prevent COVID-19.
Post-HSCT care at home: How it works
- Cell collection (if applicable), conditioning, and HSCT all take place in the outpatient setting.
- From day 1 after transplant onward, the patient receives all care at home.
- A nurse practitioner or physician assistant visits the patient every morning to draw labs, which are run at the hospital.
- A nurse visits every afternoon to give the patient supportive care.
- Patients are given the tools to video chat with physicians.
- Patients must live within 1 hour of Duke’s transplant center or relocate to furnished apartments near the transplant center.
Phase 1 trial: Feasible and safe
- Dr. Sung and colleagues have completed a phase 1 trial, which suggested that post-HSCT care at home was feasible and safe.
- Outcomes were similar to outcomes in patients who do not receive post-HSCT care at home.
- The results were presented at ASH 2017 (Blood. 2017;130:74 5; https://bit.ly/2UelgVo).
Phase 2 trials: Microbiome, GVHD, and other outcomes
- With one phase 2 trial (NCT01725022), Dr. Sung and colleagues aim to determine if:
- Patients can maintain their normal bowel microbiota by receiving post-HSCT care at home, as opposed to outpatient or inpatient care.
- Treatment-related morbidities and mortality are similar between the groups.
- Care at home improves quality of life and reduces costs.
- Trial details can be found here: https://bit.ly/2JRnY0Y.
- In the other phase 2 trial (NCT02218151), the main goal is to compare the incidence of grade 2-4 acute GVHD at 6 months in patients receiving care at home vs. inpatient or outpatient care.
- The theory is that maintaining the microbiome will reduce the risk of GVHD.
- A case of GVHD can add $100,000 to the cost of care, Dr. Sung noted.
- Trial details can be found here: https://bit.ly/32vr8y3.
COVID-19 and the microbiome
- Dr. Sung and colleagues are also conducting a trial of Lactobacillus rhamnosus GG (LGG) as prophylaxis for COVID-19 (NCT04399252).
- Research has shown that giving LGG to mice with Pseudomonas aeruginosa pneumonia can:
- Help prevent lung injury and significantly improve survival (Shock. 2013;40:496-503; https://bit.ly/3khQBRr).
- Help modulate the microbiome and immune system, leading to decreased inflammation, TNF-alpha, IL-2, and IL-6, as well as increased regulatory T cells (Clin Nutr. 2017;36:1549-1557; https://bit.ly/35lENJZ).
- Dr. Sung noted that TNF-alpha, IL-2, and IL-6 have also been implicated in COVID-19 and associated with increased lung injury.
- Dr. Sung and colleagues have theorized that LGG could decrease lung injury and the symptoms of COVID-19 and perhaps even prevent COVID-19.
- The researchers are conducting a randomized trial of LGG in household contacts of patients with COVID-19 (https://bit.ly/2GRSC9x).
- For more details on the trial, email email@example.com or visit https://bit.ly/2IsLjWh.
Dr. Sung and Dr. Henry have no relevant disclosures. Duke's transplant trials are funded by grants from the National Institutes of Health. Funding for the COVID-19 trial is provided by the Duke Microbiome Center and philanthropic giving. The LGG and placebo used in the trial are provided by DSM.
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