This is a study investigating folate deficiency (lack of folic acid in the blood) in patients who take the drug olaparib to treat their advanced ovarian or breast cancer.
This is a study investigating folate deficiency (lack of folic acid in the blood) in patients who take the drug olaparib to treat their advanced ovarian or breast cancer. The primary goal of this study is to determine the frequency and timing of folate deficiency, and to learn more about whether giving folic acid supplementation (vitamin) will help delay or avoid deficiency in these patients. Deficiency can cause doctors to reduce or stop treatment with olaparib. In this case, patients are not getting the best treatment for their cancer due to the unwanted side effect.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Folic Acid 1 mg by mouth daily
Rush University Medical Center
Chicago, Illinois, United States
Number of Participants Who Have Developed Folate Deficiency (Serum Folate Level < 7 ng/ml) on Olaparib
The number of patients with ovarian and breast cancers who were treated with olaparib and developed folate deficiency was counted.
Time frame: Serum folate levels were measured in each enrolled subject: at baseline, then every 2 weeks X 3 months, then monthly X 9 months. Accrual occurred over a 2-year period.
Timing of Folate Deficiency Development
The number of weeks between the beginning of olaparib treatment and the development of folate deficiency
Time frame: From the beginning of olaparib treatment until the development of folate deficiency
The Number of Participants Who Developed Decreased Hemoglobin by ≥ 1 g/dl Relative to Baseline
To evaluate the effect of olaparib on hemoglobin level in both arms of the study as compared to baseline before the beginning of the olaparib treatment
Time frame: Hemoglobin levels were measured in each enrolled subject: at baseline, then every 2 weeks X 3 months, then monthly X 9 months. Accrual occurred over a 2-year period.
Serum Folate
To evaluate the effect of folic acid supplementation on serum folate levels as compared to the no Folate supplementation arm. Serum folate was measured every 2 weeks for the first 3 months, and then monthly for 9 months during olaparib therapy.
Time frame: Serum folate levels were measured in each enrolled subject: at baseline, then every 2 weeks X 3 months, then monthly X 9 months. Accrual occurred over a 2-year period.
Number of Participants Requiring Blood Transfusions
The number of patients requiring blood transfusions during olaparib treatment was counted.
Time frame: Over 12 months while on olaparib therapy.
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Number of Participants Requiring Olaparib Dose Interruptions
The number of subjects requiring interruptions in olaparib treatment for any reason was counted.
Time frame: Over 12 months while on olaparib therapy.
Number of Participants Requiring Olaparib Dose Reductions for Any Reason
The number of participants requiring olaparib dose reductions for any reason was counted.
Time frame: Over 12 months while on olaparib therapy.
Number of Participants Requiring Olaparib Discontinuation
The number of subjects who had their olaparib treatment discontinued was counted.
Time frame: Over 12 months while on olaparib therapy