What is the mechanism of action of this treatment?

The most common treatments for ovarian cancer include chemotherapy agents such as paclitaxel, topotecan, and pegylated liposomal doxorubicin, which work by interfering with the cancer cells' ability to divide and grow. Angiogenesis inhibitors like bevacizumab target the blood vessels that supply the tumor, effectively starving the cancer cells. For patients treated with olaparib, a PARP inhibitor, folic acid supplements are studied to prevent folate deficiency, which can be a side effect of the treatment. Preventing folate deficiency is crucial as it allows patients to continue their cancer therapy without interruptions, ensuring they receive the most effective treatment for their condition.

What side effects are associated with this type of intervention?

Common treatments for ovarian cancer include chemotherapy, targeted therapy, and PARP inhibitors like olaparib. Chemotherapy can cause side effects such as nausea, vomiting, hair loss, fatigue, and increased risk of infection. Targeted therapies may lead to side effects like high blood pressure, fatigue, and gastrointestinal issues. PARP inhibitors, including olaparib, can cause nausea, fatigue, anemia, and folate deficiency, which may necessitate folic acid supplementation to prevent treatment interruptions.

What prior FDA approvals exist?

The FDA has approved several PARP inhibitors for the treatment of ovarian cancer, particularly for patients with BRCA mutations or those with platinum-sensitive recurrent disease. Olaparib, rucaparib, and niraparib are notable examples. Olaparib was one of the first PARP inhibitors approved and has shown efficacy in improving progression-free survival (PFS) in patients with BRCA-mutated ovarian cancer. Rucaparib and niraparib have also been approved for similar indications, demonstrating significant benefits in PFS for patients with both BRCA-mutated and homologous recombination deficiency (HRD) positive ovarian cancer. These approvals highlight the importance of targeted therapies in the management of ovarian cancer.

What other types of research exist?

Promising alternatives to folic acid supplements for preventing folate deficiency in ovarian cancer patients may include bioactive forms of folate like methylfolate, dietary interventions rich in natural folate, and combination therapies with vitamins B12 and B6.

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Folic Acid for Ovarian and Breast Cancer

Phase 2 & 3

Waitlist Available

Research Sponsored by Rush University Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 2 years

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects from the intervention (folic acid tablet) may include allergic reactions for those sensitive to its components. However, since it's a vitamin supplement being tested alongside olaparib therapy rather than a new medication itself, significant side effects are not commonly expected.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Frequency of Folate Deficiency

Timing of Folate Deficiency

Secondary study objectives

Complete Blood Count (CBC)

Number of olaparib discontinuations

Number of olaparib dose interruptions

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for ovarian cancer include chemotherapy agents such as paclitaxel, topotecan, and pegylated liposomal doxorubicin, which work by interfering with the cancer cells' ability to divide and grow. Angiogenesis inhibitors like bevacizumab target the blood vessels that supply the tumor, effectively starving the cancer cells. For patients treated with olaparib, a PARP inhibitor, folic acid supplements are studied to prevent folate deficiency, which can be a side effect of the treatment. Preventing folate deficiency is crucial as it allows patients to continue their cancer therapy without interruptions, ensuring they receive the most effective treatment for their condition.