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

Sidney Kimmel Cancer Center at Thomas Jefferson University

Status and phase

Completed

Phase 1

Conditions

Post Biopsy

Pre-surgery

Stage 0/1 Breast Cancer

Treatments

Drug: IV/oral n-acetylcysteine

Study type

Interventional

Funder types

Other

Identifiers

NCT01878695

JT 2312 (Other Identifier)

12D.396

Details and patient eligibility

About

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

Enrollment

13 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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