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

May 1, 2025 updated by: Sidney Kimmel Cancer Center at Thomas Jefferson University

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Jefferson Myrna Brind Center for Integrative Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Drug: IV/oral n-acetylcysteine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy
Time Frame: 2-4 weeks
To assess the feasibility of evaluating the effect of n-acetylcysteine on tumor cell metabolism by assessing the changes in expression of caveolin -1 and MCT4 in cancer associated fibroblasts in pre and post therapy breast tissue treated with NAC.
2-4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety
Time Frame: 2-4 weeks
To confirm the safety of combined oral and IV NAC in patients with breast cancer. This will be evaluated by the number of participants with adeverse events and Grade 3/4 toxicities according to CTCAE v3.0
2-4 weeks
2. To access the changes in HIF-1 alpha and p65 subunit of NFB in tumor stroma in pre and post therapy breast tissue treated with NAC
Time Frame: 2-4 weeks
To access the changes in HIF-1 alpha and p65 subunit of NFB in tumor stroma in pre and post therapy breast tissue treated with NAC
2-4 weeks
To evaluate potential effects of NAC on quality of life and fatigue
Time Frame: 2-4 weeks
To evaluate potential effects of NAC on quality of life and fatigue using the FACT-G, Brief Fatigue Inventory, and PROMIS quality assessment instruments.
2-4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sidney Kimmel Cancer Center at Thomas Jefferson University

Investigators

  • Principal Investigator: Daniel Monti, MD, MBA, Sidney Kimmel Cancer Center at Thomas Jefferson University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 26, 2012

Primary Completion (Actual)

May 14, 2015

Study Completion (Actual)

May 14, 2015

Study Registration Dates

First Submitted

June 11, 2013

First Submitted That Met QC Criteria

June 12, 2013

First Posted (Estimated)

June 17, 2013

Study Record Updates

Last Update Posted (Actual)

May 2, 2025

Last Update Submitted That Met QC Criteria

May 1, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12D.396
  • JT 2312 (Other Identifier: JeffTrial Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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