TriCAM (NCT02976558) – a randomized controlled pilot study of complementary medicine in allogeneic stem cell transplantation to improve quality of life

Abstract

Background: Allogeneic stem cell transplantation (aSCT) frequently leads to prolonged impaired quality of life (Qol) and depression. To reduce symptom burden and improve Qol, we implemented a complementary medicine approach (TriCAM). Methods: In a randomized, controlled clinical trial (NCT02976558), we enrolled 36 patients undergoing aSCT. In addition to standard care, the intervention group received Traditional Chinese Medicine acupuncture (TCMA), music therapy (TaKeTiNa) and active clown role playing. FACT-G was used to assess Qol and HADS-D to asses anxiety and depression. We monitored safety of TCMA as well as typical complications during aSCT. Results: TCMA did not result in more hematomas, soft tissue infections or bacteriaema. Clinical depression was reduced in the intervention group compared to the control group (p = 0.01). There was a trend towards improvement of Qol over time (P = 0.10) and in reducing aGvHD (P = 0.084) in the intervention group compared to the control group. Conclusions: Our trial is the first to show TCMA to be safe in aSCT. TriCAM showed a trend towards mitigating the loss of QoL and significantly reduced depression in patients undergoing aSCT. The promising results of this pilot study give a first positive signal for safety and efficacy allowing for the design of larger studies to confirm the results and support this particularly vulnerable patient group. Trial registration: ClinicalTrials.gov NCT02976558. Registered 29 November 2016.