None listed
Conditions
Brief summary
Selenium is a trace mineral commonly taken by people hoping to prevent or treat cancer. However certain types of selenium could be harmful, especially at the high doses that show promise in reducing side effects of radiotherapy or chemotherapy without reducing their effectiveness. It is important to know which form of selenium can be most safely used at higher doses and have the best effect. In this clinical research study we will compare the effects of three different types of selenium in people with cancer or chronic lymphocytic leukaemia, looking at their safety and beneficial effects on the cancer.
Interventions
Cohort 1
Arm 1: sodium selenite taken orally at doses of 400 mcg elemental selenium daily for eight weeks
Arm 2: L-selenomethionine taken orally at doses of 400 mcg elemental selenium daily for eight weeks
Arm 3: Se-methyl-selenocysteine taken orally at doses of 400 mcg elemental selenium daily for eight weeks.
Cohort 2
Arm 1: sodium selenite taken orally dosed at 1600 mcg of elemental selenium daily for 4 weeks then escalating to 6400mcg daily for a further 4 week in absence of dose-limiting
Cohort 1 Arm 1: sodium selenite taken orally at doses of 400 mcg elemental selenium daily for eight weeks Arm 2: L-selenomethionine taken orally at doses of 400 mcg elemental selenium daily for eight weeks Arm 3: Se-methyl-selenocysteine taken orally at doses of 400 mcg elemental selenium daily for eight weeks. Cohort 2 Arm 1: sodium selenite taken orally dosed at 1600 mcg of elemental selenium daily for 4 weeks then escalating to 6400mcg daily for a further 4 week in absence of dose-limiting toxicities Arm 2: L-selenomethionine taken orally dosed at 1600 mcg of elemental selenium daily for 4 weeks then escalating to 6400mcg daily for a further 4 week in absence of dose-limiting toxicities Arm 3: Se-methyl-selenocysteine taken orally dosed at 1600 mcg of elemental selenium daily for 4 weeks then escalating to 6400mcg daily for a further 4 week in absence of dose-limiting toxicities.
Sponsors
Waikato District Health Board
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subjects with either chronic lymphocytic leukaemia (peripheral blood lymphocyte count > 10 x 10^9/l) or metastatic cancer, in whom the use of chemotherapy is not anticipated in the next 3 months 2. Adequate liver, renal and bone marrow function 3. ECOG performance status 0-2 4. Life expectancy over 6 months
Exclusion criteria
1. Subjects treated within the last 4 weeks with cytotoxic chemotherapy, anticancer biological therapy (excluding hormonal therapy for prostate cancer) or radiotherapy 2. Unable to swallow or absorb study tablets 3. Concurrent selenium supplements over 100 mcg/day
Outcome results
None listed