AbstractBackgroundDry heat, immersive, and Hammam sauna baths have been shown to aid fluid removal in haemodialysis patients but require high ambient temperatures, large volumes of water and sufficient space, all of which limit their widespread use in India. We aimed to study the safety and efficacy of a commercially available, inexpensive, portable steam sauna bath for this purpose.MethodsIn this pilot phase II clinical trial, six adult prevalent haemodialysis patients each underwent 6 sauna sessions lasting 30-60 minutes, on all non-dialysis days, for 2 weeks. Weight, blood pressure, serum urea, creatinine, electrolytes, haematocrit, core body temperature, thermal comfort, and thirst visual analogue scale were measured before and after each session. Karnofsky performance status (KPS) and Dialysis Symptoms Index (DSI) were measured at the beginning and end of the intervention period. The primary end points were per session weight loss and interdialytic weight gain (IDWG).ResultsPatients experienced a median weight loss of 0.35 kg, median fall in systolic and diastolic BP of 10 mm Hg and 2 mm Hg respectively (p < 0.001 for all) without significant change in IDWG (p = 0.46). Mean thermal comfort was 5.41 ± 0.56 out of 8, there was no significant increase in thirst (p = 0.06) and no significant change in KPS and DSI scores (p = 1.00 and 0.32 respectively). No adverse events were noted.ConclusionsThe portable steam sauna is safe, but modestly effective for fluid removal in haemodialysis patients, and may not influence IDWG.Details of each author’s contributions
Intra-tumor injection of H101, a recombinant adenovirus, in combination with chemotherapy in patients with advanced cancers: A pilot phase II clinical trial