Pilot Study of Anti-oxidant Supplementation With N-Acetyl Cysteine in Stage 0/I Breast Cancer

NCT ID: NCT01878695

Last Updated: 2025-05-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-26
• Study Completion Date: 2015-05-14

Brief Summary

NAC is the N-acetyl derivative of the naturally occurring amino acid, L-cysteine. It is a common over-the-counter supplement and also is available as an injectable pharmaceutical that protects the liver in cases of acetaminophen overdose. In the exercise physiology literature, both oral and injectable NAC have been shown to reduce fatigue and improve recovery from exertion which has interesting implications for exploring cancer-related fatigue.

In terms of cancer cell biology, reactive oxygen species (ROS) may play an important role in the development and progression of breast cancer

Conditions

Stage 0/1 Breast Cancer; Post Biopsy; Pre-surgery

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IV and oral n-acetylcysteine

50-150mg/kg of n-acetylcysteine intravenously once a week for at least two weeks.

600mg n-acetylcysteine orally twice daily except on day of infusion

Group Type: EXPERIMENTAL

IV/oral n-acetylcysteine

Intervention Type: DRUG

Interventions

IV/oral n-acetylcysteine

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Demographic • Females ≥18 years of age

Disease related

• Stage 0/I breast cancer by biopsy (patients may be consented and screened with suspected breast cancer, but no treatment will occur until cancer is confirmed by their biopsy).
• Awaiting surgery which will consist of either lumpectomy or mastectomy.
• ECOG performance status 0-1

Laboratory

• Laboratory values that would not prevent the patient from receiving treatment as determined by the PI or study oncologist
• Serum creatinine ≤2.0 mg/dL
• Serum bilirubin ≤2.0 X ULN
• Serum HgB ≥8.0 mg/dL

General

• Competent to comprehend, sign, and date an IRB-approved informed consent form
• Female subjects of childbearing potential have a negative pregnancy test

Exclusion Criteria

• Disease Related

• History or known presence of metastases
• History of another primary cancer, except:
• Curatively treated cervical carcinoma in situ, or
• Curatively resected non-melanomatous skin cancer, or
• Other primary solid tumor curatively treated with no known active disease present and no treatment administered for ≤ 3 years prior to enrollment

• Other concurrent anticancer chemotherapy within 4 weeks as determined by the PI
• Any co-morbid disease that would increase risk of toxicity as determined by PI

Medications/Treatments

• Subjects requiring chronic use of immunosuppressive agents (eg, methotrexate, cyclosporine, corticosteroids)
• Recent infection requiring a course of systemic anti-infectives that was completed ≤ 14 days prior to enrollment (exception can be made at the judgment of the PI for oral treatment of an uncomplicated urinary tract infection ([UTI])

General

• History of any medical or psychiatric condition or addictive disorder, or laboratory abnormality that, in the opinion of the PI, may increase the risks associated with study participation or study drug administration or may interfere with the conduct of the study or interpretation of study requirements
• History of bronchospasm or severe asthma as determined by the PI
• Subject unwilling or unable to comply with study requirements
• Known positive test(s) for human immunodeficiency virus infection, hepatitis C virus, chronic active hepatitis B infection
• Documented history of alcohol, cocaine or intravenous drug abuse ≤ 6 months of enrollment

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Sidney Kimmel Cancer Center at Thomas Jefferson University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel Monti, MD, MBA

Role: PRINCIPAL_INVESTIGATOR

Sidney Kimmel Cancer Center at Thomas Jefferson University

Locations

Jefferson Myrna Brind Center for Integrative Medicine

Philadelphia, Pennsylvania, United States

Countries

United States

Related Links

http://hospitals.jefferson.edu/

Thomas Jefferson University Hospital

Other Identifiers

JT 2312

Identifier Type: OTHER

Identifier Source: secondary_id

12D.396

Identifier Type: -

Identifier Source: org_study_id