Hansen, P.B., & Penkowa, M. (2017). Bismuth adjuvant ameliorates adverse effects of high-dose chemotherapy in patients with multiple myeloma and malignant lymphoma undergoing autologous stem cell transplantation: A randomised, double-blind, prospective pilot study. Supportive Care in Cancer, 25, 1279–1289.

To study the effects of oral bismuth in patients prior to autologous stem cell transplantation on reducing the adverse effects of high-dose chemotherapy, including mucositis, neutropenia, and bacteremia.

Randomized, double-blind controlled study either to intervention or placebo group. Bismuth or placebo was 1,000 mg × 2 orally daily for 5 days, followed by 10 days with a daily dose of 500 mg × 2 orally. The first 5 days of bismuth or placebo treatment were prior to the start of chemotherapy regimens, which started on day −3 (multiple myeloma) and day −7 (lymphoma) before ASCT (day 0). The 10 days on the lower dose of bismuth or placebo also started on day −3 (multiple myeloma) and day −7 (lymphoma). On day +4, all patients received 6 mg pegfilgrastim to reduce neutropenia.

• N = 50   
• AGE: 32-73 years
• MALES: 66%  
• FEMALES: 34%
• CURRENT TREATMENT: Chemotherapy
• KEY DISEASE CHARACTERISTICS: Diagnosis of multiple myeloma or lymphoma 
• OTHER KEY SAMPLE CHARACTERISTICS: Autologous stem cell transplantation candidates

• SITE: Single site   
• SETTING TYPE: Inpatient    
• LOCATION: Copenhagen, Denmark

• PHASE OF CARE: Active anti-tumor treatment
• APPLICATIONS: Palliative care

• Randomized, double-blind study to one of two groups receiving oral bismuth or a placebo 

Laboratory results: Hemoglobin, leukocytes, differential count, thrombocytes, and reticulocytes. Stomatitis, diarrhea, fever, febrile neutropenia and documented infections based on the Common Criteria for Adverse Events, version 3.0.

Results showed a reduction in grade 2 stomatitis, febrile neutropenia, and infections caused by high-dose chemotherapy. Bismuth reduced significantly the incidence of grade 2 stomatitis, as it occurred only in 2 of 13 patients (15%, two-tailed p = 0.001)

Oral bismuth is shown to be effective in certain patient groups. Oral bismuth may be effective in reducing high-dose chemotherapy effects of mucositis, neutropenia, and infections. The study indicates that there may be a gender difference in side effects; therefore, more studies are warranted to determine the impact of gender differences of treatment and prevention of cytotoxic effects of the treatment.

Small sample (< 100)

First study to use this intervention in hematologic inpatients. More research is needed on the preventative properties of oral bismuth.