Lung Cancer
Conditions
Keywords
Lung cancer, vitamin D, pharmacokinetics
Brief summary
Hypovitaminosis D is highly prevalent in people with lung cancer, and may have adverse clinical consequences. The long and variable pharmacokinetic half-life of vitamin D makes prompt vitamin D replacement problematic. This is an open, one-armed therapeutic intervention using a loading dose of vitamin D that will be predicted to increase plasma 25-hydroxyvitamin D concentrations of every patient well into the normal range (\> 100 nmol/L) within 2 or 3 weeks and monitored after 2 and 3 weeks of loading and maintenance dose. Preliminary data will also be obtained to identify potentially clinical important outcome benefits for future investigation. The outcomes are 1. plasma 25OHD concentration 2. Vitamin D binding protein and other plasma concentrations 3. Mood and symptom
Interventions
DIETARY_SUPPLEMENTvitamin D
vitamin D3 20,000 IU per day for 14 days followed by 10,000 IU per day for a further 7 days
Sponsors
Jewish General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Any patient with advanced lung cancer whether or not receiving specific anti-cancer therapy 2. Mentally competent (but need not be fluent in French or English if capable neutral translator available) 3. Self report of reduced food intake and/or involuntary weight loss of any extent at time of enrollment: does not have to be documented
Exclusion criteria
1. Current diagnosis of primary hyperparathyroidism 2. Nephrocalcinosis 3. Current or suspected active tuberculosis, histoplasmosis, sarcoidosis, or other granulomatous disease 4. Current using a vitamin D supplement providing \> 1000 IU/day 5. Current prescribed calcitriol in any dose 6. History of extensive sunlight exposure (\> 30 min summer sunlight exposure per day for more than 5 days per week) in previous 3 months 7. Expected to die within next 2 months 8. Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma 25-hydroxyvitamin D concentration | 3 weeks | Plasma 25OHD concentration measured within 24 h prior to commencing vitamin D therapy, and again after 14 and 21 days of continuous vitamin D therapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mood | 3 weeks | Two validated brief mood assessment questionnaires measured 1. On two occasions (one week apart) at baseline prior to staring therapy 2. After 2 weeks of therapy 3. After 3 weeks of therapy |
| Symptoms | 3 weeks | As with mood questionnaire, a symptom questionnaire (Edmonton Symptom Assessment System) will be administered two times (one week apart) prior to starting vitamin therapy and after 14 and 21 days of continuous vitamin D administration |
Countries
Canada
Outcome results
None listed