Folic Acid for Ovarian and Breast Cancer

Overseen By Lois Winkelman, RN

Age: 18+

Sex: Female

Trial Phase: Phase 2 & 3

Sponsor: Rush University Medical Center

Must be taking: Olaparib

Must not be taking: Folic acid, Strong CYP3A inhibitors

Disqualifiers: Folic acid deficiency, Other malignancy, Cardiac conditions, Brain metastases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: Up to approximately 2 years

10 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing if folic acid supplements can help patients with advanced ovarian or breast cancer who are taking olaparib. The goal is to prevent folate deficiency, which can cause interruptions in their cancer treatment. Olaparib is a medication approved for use in patients with advanced ovarian cancer.

Eligibility Criteria

This trial is for post-menopausal women over 18 with advanced ovarian or breast cancer starting olaparib treatment. They must have normal organ and bone marrow function, no recent blood transfusions, a life expectancy of at least 16 weeks, and be able to swallow pills. Excluded are those with certain other cancers, recent participation in another clinical study, known hypersensitivity to folic acid or olaparib, previous PARP inhibitor treatment including Olaparib, current folic acid deficiency or supplementation.

Inclusion Criteria

I have ovarian or breast cancer and am recommended to start olaparib.

Willing and able to provide signed informed consent

Patients must have normal organ and bone marrow function measured within 28 days prior to administration of study treatment as defined below: Haemoglobin ≥ 9 g/dL with no blood transfusion in the past 28 days, Absolute neutrophil count (ANC) ≥ 1.5 x 109/L, Platelet count ≥ 100 x 109/L, Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN), Aspartate aminotransferase (AST) (Serum Glutamic Oxaloacetic Transaminase (SGOT)) / Alanine aminotransferase (ALT) (Serum Glutamic Pyruvate Transaminase (SGPT)) ≤ 2.5 x institutional upper limit of normal unless liver metastases are present in which case they must be ≤ 5x ULN, Patients must have creatinine clearance estimated of ≥51 mL/min, Eastern Cooperative Oncology Group (ECOG) performance status 0-1), Patients must have a life expectancy ≥ 16 weeks, At least one lesion (measurable and/or non-measurable) that can be accurately assessed at baseline by CT and is suitable for repeated assessment

Exclusion Criteria

I have been cancer-free for over 5 years, except for certain skin, cervical, breast, or endometrial cancers.

I am not currently using, or have stopped using certain strong or moderate medications as required before starting olaparib.

I had major surgery more than 2 weeks ago and have recovered.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive olaparib and are monitored for folate deficiency. Folic acid supplementation is provided to some participants.

Up to approximately 2 years

Every 2 weeks for the first 3 months, then monthly

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Folic Acid

Trial Overview The study tests if taking folic acid tablets can prevent folate deficiency in patients using the drug olaparib for treating advanced ovarian or breast cancer. Folate deficiency can lead to reduced or stopped cancer treatment; this study aims to see if supplements help avoid that.

Participant Groups

Group I: Folic Acid Experimental Treatment 1 Intervention

Folic Acid supplement 1 mg by mouth daily

Group II: No Supplementation Active Control 1 Intervention

Who Is Running the Clinical Trial?

Rush University Medical Center

Lead Sponsor

Trials

448

Recruited

247,000+