Stage 0/1 Breast CancerPhase 1NACNCT01878695
Pilot Study of Anti-oxidant Supplementation With N-Acetyl Cysteine in Stage 0/I Breast Cancer
A Phase 1 study testing IV/oral n-acetylcysteine in people with Stage 0/1 Breast Cancer and Post Biopsy, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Stage 0/1 Breast Cancer, Post Biopsy, Pre-surgery
- What is being tested?
- IV/oral n-acetylcysteine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jul 2012to 14 May 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Jefferson Myrna Brind Center for Integrative Medicine
Philadelphia, Pennsylvania, 19107
About this study
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
- Being tested
- IV/oral n-acetylcysteine
- Keywords
- Integrative Medicine, Breast Cancer, Stage 0, Stage 1
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV/oral n-acetylcysteineDrug
| Study group | Role | What they receive |
|---|---|---|
| IV and oral n-acetylcysteine | Experimental | 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 Receives: Drug: IV/oral n-acetylcysteine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy
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.
Measured: 2-4 weeks
Secondary outcomes (3)
Safety
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
Measured: 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
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
Measured: 2-4 weeks
To evaluate potential effects of NAC on quality of life and fatigue
To evaluate potential effects of NAC on quality of life and fatigue using the FACT-G, Brief Fatigue Inventory, and PROMIS quality assessment instruments.
Measured: 2-4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2013 (estimated)
- Study start26 Jul 2012
- Primary completion14 May 2015
- Study completion14 May 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage 0/1 Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Monti, MD, MBA, Principal investigator, Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01878695
- Sponsor's protocol ID
- 12D.396
- Other IDs
- JT 2312
- Acronym
- NAC
- Status last verified
- May 2025
- First submitted
- 11 Jun 2013
- Last updated
- 2 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Anti-oxidant Supplementation With N-Acetyl Cysteine in Stage 0/I Breast Cancer
- ClinicalTrials.gov ID
- NCT01878695
- Acronym / sponsor ID
- NAC / 12D.396
- Conditions
- Stage 0/1 Breast Cancer, Post Biopsy, Pre-surgery
- Keywords
- Integrative Medicine, Breast Cancer, Stage 0, Stage 1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- 26 Jul 2012 (actual)
- Primary completion
- 14 May 2015 (actual)
- Study completion
- 14 May 2015 (actual)
- First posted
- 17 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IV and oral n-acetylcysteine | Experimental | Drug: IV/oral n-acetylcysteine50-150mg/kg of n-acetylcysteine intravenously once a week for at least two weeks. 600mg n-acetylcysteine orally twice daily except on day of infusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (17 listed)
- Disease Related
- 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
- Medications/Treatments
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IV/oral n-acetylcysteine | Drug | IV and oral n-acetylcysteine |
Primary outcome
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.
3 secondary outcomes
Safety
Time frame: 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 evaluate potential effects of NAC on quality of life and fatigue
Time frame: 2-4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2025.
- Thomas Jefferson University HospitalLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Monti, MD, MBA principal investigator
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IV/oral n-acetylcysteine in people with Stage 0/1 Breast Cancer and Post Biopsy, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy (time frame: 2-4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2025.