← Back to Search

Folic Acid Tablet for Ovarian 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
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
Female, post-menopausal, ≥18 years of age inclusive, at the time of signing the consent form
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 2 years
Awards & highlights

Study Summary

This trial is investigating whether giving folic acid supplements to patients with ovarian or breast cancer who are taking the drug olaparib will help delay or avoid deficiency.

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.Check my eligibility
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.See study design
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a woman over 18 and have gone through menopause.
Select...
I have ovarian or breast cancer and am recommended to start olaparib.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Frequency of Folate Deficiency
Timing of Folate Deficiency
Secondary outcome measures
Complete Blood Count (CBC)
Number of olaparib discontinuations
Number of olaparib dose interruptions
+5 more

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

Find a Location

Who is running the clinical trial?

Rush University Medical CenterLead Sponsor
418 Previous Clinical Trials
162,489 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the results of past studies done on the effects of Folic Acid Tablet?

"There are currently 14 Folic Acid Tablet clinical trials ongoing with 2 in Phase 3. Most trials are based in Hangzhou, Zhejiang but there are 36 total locations for these trials."

Answered by AI

For what medical reasons is this pill most often prescribed?

"The recommended course of treatment for those with nutritional deficiencies, folate deficiency, and vitamin deficiencies is Folic Acid Tablet."

Answered by AI

Who else is applying?

What state do they live in?
Wisconsin
How old are they?
18 - 65
What site did they apply to?
Rush University Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
~1 spots leftby Sep 2024