Folic Acid for Ovarian and Breast Cancer

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Waitlist Available

Sponsor: Rush University Medical Center

No Placebo Group

Prior Safety Data

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

I am a woman over 18 and have gone through menopause.

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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.

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Treatment Details

Interventions

Folic Acid (Vitamin)

Trial OverviewThe 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

2Treatment groups

Experimental Treatment

Active Control

Group I: Folic AcidExperimental Treatment1 Intervention

Folic Acid supplement 1 mg by mouth daily

Group II: No SupplementationActive Control1 Intervention