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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether folic acid can benefit individuals with advanced ovarian or breast cancer who are beginning treatment with olaparib. Researchers aim to determine if folic acid can address low folate levels in the blood during this treatment. Participants will either take a daily folic acid supplement or no supplement to compare outcomes. Women with ovarian or breast cancer recommended for olaparib and not already taking folic acid may be suitable for this study. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to important findings.

Is there any evidence suggesting that folic acid is likely to be safe for humans?

Research has shown that folic acid, or vitamin B9, has mixed effects on cancer. Some studies suggest that higher folic acid intake might reduce breast cancer risk. However, other research indicates that folic acid could increase ovarian cancer risk, particularly in women with endometriosis.

Folic acid is generally safe and well-tolerated, with many people taking it as a dietary supplement without issues. However, like any treatment, monitoring for side effects is important.

This study is in the advanced stages of clinical trials, indicating that earlier studies have reviewed its safety. Always consult a healthcare provider before joining a trial to understand the potential benefits and risks. ^{1 2 3 4 5}

Why are researchers excited about this study treatment for cancer?

Researchers are excited about using folic acid for ovarian and breast cancer because it offers a potential new approach to treatment. Unlike traditional chemotherapy and hormone therapies, which can come with significant side effects, folic acid is a vitamin supplement that is generally well-tolerated and may enhance the body's natural repair processes. The idea is that folic acid could support healthy cell function and potentially inhibit cancer cell growth, offering a gentler alternative to existing treatments. This could be a game-changer for patients seeking less toxic cancer care options.

What evidence suggests that folic acid might be an effective treatment for ovarian and breast cancer?

Research shows that people taking olaparib for advanced ovarian or breast cancer often have low folate levels. Folate, or folic acid, is a vitamin crucial for maintaining healthy cells. One study found that almost all patients on olaparib had low folate levels. Some research suggests that increasing folate intake might reduce ovarian cancer risk, although results are mixed. In this trial, participants will receive either a folic acid supplement or no supplementation. Folic acid supplements could help address folate deficiencies in these patients. ^{4 6 7 8 9}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10935767/

Folic acid: friend or foe in cancer therapy - PubMed Central - NIH In this review article, we describe contradictory data regarding the role of folic acid in cancer development and progression.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0006497124080558

A Prospective Trial of Serum Folate Levels in Women with ... Conclusions: We discovered that folate deficiency occurred in nearly all patients who were started on olaparib for breast or ovarian cancer ...

3. nature.com nature.com/articles/s41416-022-02031-x

Folate receptor alpha in ovarian cancer tissue and patient ... Survival rates for ovarian cancer remain poor, and monitoring and prediction of therapeutic response may benefit from additional markers.

4. academic.oup.com academic.oup.com/jnci/article/96/5/396/2521157

Dietary Folate Intake and Incidence of Ovarian Cancer Conclusion: A high dietary folate intake may play a role in reducing the risk of ovarian cancer, especially among women who consume alcohol. Topic: ethanol ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10390886/

Folate Intake and Ovarian Cancer Risk among Women with ... Higher dietary folate intake was associated with an increased risk of ovarian cancer for women with endometriosis [OR, 1.37 (1.01–1.86)] but not for women ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6132377/

Folate and Its Impact on Cancer Risk - PMC Studies have demonstrated increased risk, no effect, and decreased risk. This review summarizes findings of mixed results between folate intake, serum levels, ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0002916523293867

Folate intake, alcohol use, and postmenopausal breast ... Several epidemiologic studies suggest that higher folate intakes are associated with lower breast cancer risk, particularly in women with moderate alcohol ...

8. journals.sagepub.com journals.sagepub.com/doi/10.1177/03000605231223064

Folic acid: friend or foe in cancer therapy In this review article, we describe contradictory data regarding the role of folic acid in cancer development and progression.

9. journals.lww.com journals.lww.com/md-journal/fulltext/2021/01220/the_effect_of_folate_intake_on_ovarian_cancer.1.aspx

The effect of folate intake on ovarian cancer risk Our meta-analysis demonstrates that folate intake had no significant association on the risk of ovarian cancer.