Folic Acid Tablet for Breast Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Rush University Medical Center, Chicago, IL
Breast Cancer+3 More
Folic Acid Tablet - Drug
Eligibility
18+
Female
Eligible conditions
Select

Study Summary

This study is evaluating whether folic acid supplements can help prevent folate deficiency in patients who take olaparib.

See full description

Eligible Conditions

  • Breast Cancer
  • Folic Acid Deficiency
  • Ovarian Cancer

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Folic Acid Tablet will improve 2 primary outcomes and 8 secondary outcomes in patients with Breast Cancer. Measurement will happen over the course of Up to approximately 2 years.

Year 2
Complete Blood Count (CBC)
Frequency of Folate Deficiency
Number of olaparib discontinuations
Number of olaparib dose interruptions
Number of olaparib dose reductions
Number of required blood tranfusions
Progression-free survival (PFS)
Response Rate to olaparib
Serum folate
Timing of Folate Deficiency

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

2 Treatment Groups

No Supplementation
1 of 2
Folic Acid
1 of 2
Active Control
Experimental Treatment

This trial requires 75 total participants across 2 different treatment groups

This trial involves 2 different treatments. Folic Acid Tablet is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 & 3 and have had some early promising results.

Folic Acid
Drug
Folic Acid supplement 1 mg by mouth daily
No Supplementation

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to approximately 2 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to approximately 2 years for reporting.

Who is running the study

Principal Investigator
L. U.
Prof. Lydia Usha, Associate Professor of Medicine
Rush University Medical Center

Closest Location

Rush University Medical Center - Chicago, IL

Eligibility Criteria

This trial is for female patients aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Willing and able to provide signed informed consent
Female, post-menopausal, ≥18 years of age inclusive, at the time of signing the consent form
Individuals who have ovarian cancer or breast cancer who are recommended to start olaparib
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).

Patient Q&A Section

What are common treatments for folic acid deficiency?

"The most common treatment is increased dietary intake of folate to prevent megaloblastic anemia. Occasionally, vitamin B6 supplementation is used. While there are several other treatments for megaloblastic anemia, none is as commonly prescribed as folic acid." - Anonymous Online Contributor

Unverified Answer

How many people get folic acid deficiency a year in the United States?

"About 10% of United States female teens, and almost 0.9% of high school girls are folic acid deficient. This is in contrast to many other countries." - Anonymous Online Contributor

Unverified Answer

Can folic acid deficiency be cured?

"There is tentative evidence that the risk for neural tube defects may be reduced with a supplement of 100 μg to 1 mg of folic acid in women of child-bearing age who have a history of neural tube defects, but there is insufficient evidence for vitamin B6 supplementation. We are unable to reach a conclusive conclusion as to whether there are any long term effects of supplementation. Until further research is completed, folic acid supplements should only be recommended for young or adolescent women, or for women who do not get a daily dose of folic acid, rather than solely for women who have a history of a neural tube defect." - Anonymous Online Contributor

Unverified Answer

What are the signs of folic acid deficiency?

"Signs of folate deficiency included poor balance, fatigue, and trouble thinking. These physical signs can affect a person's health if left untreated. The main treatment and management of folic acid deficiency is supplementation with folic acid or folate-rich foods. In women of childbearing potential supplemental folic acid and folate in vitamin supplements are recommended. Folic acid deficiency is much more common than previously thought with an incidence of 2.7% in the UK. Screening is needed to identify those who may have the condition and who should be treated. There is strong evidence that treatment of deficiencies during pregnancy can decrease the occurrence of spastic birth in infancy and reduce the chances of neural tube defects." - Anonymous Online Contributor

Unverified Answer

What causes folic acid deficiency?

"The development of deficiency involves environmental and nutritional factors. Folate insufficiency is prevalent both in the urban and the rural populations with a high risk of deficiency." - Anonymous Online Contributor

Unverified Answer

What is folic acid deficiency?

"Folate refers to a group of water-soluble molecules that are used for the metabolism of other molecules. They are particularly important for cells that take their energy from dividing fast (i.e. proliferative cells), such as red blood cells (erythrocytes) and germline and somatic cells of multicellular organisms, including humans. In healthy people, the quantity of folate in the bloodstream is sufficient to meet the organism's daily needs. However, if folate is not provided as a dietary component some of the necessary molecules may not be available, causing symptoms within the affected population. These include defects in cellular division, development and functioning, or even cancer, as in the case of folate deficiency." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating folic acid deficiency?

"[There are no new treatments for folic acid deficiency. Many treatments for folate deficiency have been used since the 1940s.. To find an folic acid deficiency clinical trial near you, please visit [Power (www.withpower.com/d/folic-acid-deficiency-treatments-cluster)." - Anonymous Online Contributor

Unverified Answer

How does folic acid tablet work?

"There is a decrease in plasma homocysteine concentration after the consumption of 1 mg of folic acid/day, which can explain the lack of effect on venous thromboembolism incidence after 2 years of therapy. The lower plasma concentrations of folic acid after the consumption of folic acid can be explained through an increase in deoxyribonucleotide excretion and higher plasma concentrations of folic acid related to folic acid deficiency. Both of these mechanisms can be treated with high doses of folic acid supplementation." - Anonymous Online Contributor

Unverified Answer

How serious can folic acid deficiency be?

"For most of us, the concept of a deficiency of folate, or of the vitamins that it co-ordinates, seems highly unlikely. However, folate deficiency can be a problem for people, particularly in pregnancy, and, when not remedied by folate supplementation, it can be fatal. Folic acid supplements are available in many countries and should be made available to pregnant women in developing countries. Vitamin B deficiency should also be prevented. It is likely that the [B-complex vitamins, folic acid, vitamin B and vitamins B and E may be effective for some disease states such as cancer and coronary heart disease (CHD), but it is unclear whether they affect the rate of progression of the disease." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving folic acid tablet?

"So far, there are no clinical trials demonstrating that folic acid is effective in the treatment of FMD. Although we have made many suggestions, we still need more research on this subject. It still needs to be demonstrated whether folic acid could be one of the first choices of therapy in people with peripheral neuropathy due to FMD." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of folic acid tablet?

"Most common side effects of folic acid tablet are diarrhea, dizziness, dry mouth, and nausea. Symptoms of folate depletion usually resolve after withdrawing folic acid tablet." - Anonymous Online Contributor

Unverified Answer

What does folic acid tablet usually treat?

"The most common manifestations of deficiencies and abnormalities were anemia (62%), increased red cell distribution width (23%), leukocytosis (23%), and thrombocytosis (12%); and these manifestations were not different between groups. Data from a recent study do not explain the effects of folic acid on the incidence of neural tube defects and the effects of low folic acid on plasma homocysteine. The presence of anemia or other blood abnormalities does not exclude folate deficiency. Folic acid should be studied as a cause of anemia and other blood dysfunctions." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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