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Monoterpene

Perillyl Alcohol for Breast Cancer

Phase 1

Waitlist Available

Research Sponsored by The Cleveland Clinic

Eligibility Criteria Checklist

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

Must have

Female patients over 18 years old with ECOG performance status of 0-1

Hepatic criteria: Bilirubin no greater than 1.5 mg/dL, AST and ALT no greater than 1.5 times upper limit of normal, Alkaline phosphatase no greater than 1.5 times upper limit of normal

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial is studying perillyl alcohol to see how well it works in preventing the recurrence of breast cancer.

Who is the study for?

This trial is for women over 18 who have had breast cancer treated with surgery, possibly followed by other therapies. They should not be pregnant or nursing and must use contraception if fertile. No recent non-breast cancers except certain skin cancers, no severe allergies to citrus/soybean products, and major organs need to function well.Check my eligibility

What is being tested?

The study is testing perillyl alcohol's ability to prevent breast cancer from coming back in women who've already undergone surgery (with or without additional treatments). It's a Phase I trial which means it’s early in the testing process focusing on safety and dosage.See study design

What are the potential side effects?

Specific side effects of perillyl alcohol are not listed here but generally, chemoprevention drugs can cause digestive issues, fatigue, possible allergic reactions depending on individual sensitivities to components like citrus or soy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a woman over 18 and can care for myself with minimal assistance.

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My liver function tests are within normal limits.

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My creatinine level is 1.6 mg/dL or lower.

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I had early-stage breast cancer and underwent surgery to remove it with the aim of curing.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

The Cleveland ClinicLead Sponsor

1,026 Previous Clinical Trials

1,366,076 Total Patients Enrolled

7 Trials studying Breast Cancer

5,342 Patients Enrolled for Breast Cancer

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,933,153 Total Patients Enrolled

939 Trials studying Breast Cancer

1,543,360 Patients Enrolled for Breast Cancer

George Thomas Budd, MDStudy ChairThe Cleveland Clinic

3 Previous Clinical Trials

4,824 Total Patients Enrolled

2 Trials studying Breast Cancer

4,794 Patients Enrolled for Breast Cancer

Media Library

Perillyl Alcohol (Monoterpene) Clinical Trial Eligibility Overview. Trial Name: NCT00022425 — Phase 1

Breast Cancer Clinical Trial 2023: Perillyl Alcohol Highlights & Side Effects. Trial Name: NCT00022425 — Phase 1

Perillyl Alcohol (Monoterpene) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00022425 — Phase 1

Frequently Asked Questions

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

Are enrollees presently being accepted for this investigation?

"According to clinicaltrials.gov, this research venture is no longer enrolling candidates as the last information update was made on December 17th 2013. Nonetheless, there are over 2600 other medical studies that are presently searching for participants at present time."

Answered by AI

Does this remedy have the stamp of approval from the Food and Drug Administration?

"Due to the limited clinical evidence available, this treatment was rated a 1 on our safety scale. As it is currently in Phase 1 of trials, there are not enough data points yet to conclusively assess efficacy or risk."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Perillyl Alcohol in Preventing Recurrent Breast Cancer in Women Who Have Been Treated With Surgery With or Without Adjuvant Therapy

2001. "Perillyl Alcohol in Preventing Recurrent Breast Cancer in Women Who Have Been Treated With Surgery With or Without Adjuvant Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00022425.

All > Her 2 Positive Breast Cancer > Breast