AzTrials
AzTrials

Ductal Breast Carcinoma in SituCAREFORNCT01819233

Caloric Restriction in Treating Patients With Stage 0-I Breast Cancer Undergoing Surgery and Radiation Therapy

A study testing Behavioral dietary intervention, Therapeutic conventional surgery and Radiation therapy in people with Ductal Breast Carcinoma in Situ and Invasive Ductal Breast Carcinoma, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This pilot clinical trial studies caloric restriction in patients with stage 0-I breast cancer during surgery and radiation therapy. Reducing caloric intake may prevent disease progression in patients with breast cancer. Radiation therapy uses high energy x rays to kill tumor cells. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Behavioral dietary intervention, Therapeutic conventional surgery and Radiation therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
1 siteUnited States
Study dates
8 Mar 2013to Sep 2019
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Pathologically proven diagnosis of ductal carcinoma in situ (DCIS) or invasive breast cancer
  • Ability to have breast conservation as determined by the judgment of the radiation oncologist, for which the radiation oncologist has determined that he or she will only treat the whole breast and not regional lymph nodes
  • The patient must be female
  • Age >= 18
  • If multifocal breast cancer, then it must be able to be resected through a single lumpectomy incision
  • Appropriate stage for protocol entry, including no clinical evidence for distant metastases, based upon the following minimum diagnostic workup:
Show all 34Show fewer
  • History/physical examination, including breast exam and documentation of weight and Karnofsky performance status of 80-100% for at least 60 days prior to study entry
  • Ipsilateral mammogram within 6 months prior to study entry
  • Women of childbearing potential must have a negative serum pregnancy test within 14 days of study entry
  • Women of childbearing potential must be non-pregnant and non-lactating and willing to use medically acceptable form of contraception during radiation therapy
  • Patient must capable of and provide study specific informed consent prior to study entry
  • Body mass index (BMI) >= 21
  • Weight >= 100 lbs
  • No prior history of non-breast malignancies in the past 2 years unless it was a non-melanomatous skin lesion or carcinoma in situ of the cervix
  • Patient must not have any of the following severe, active co-morbidity, defined as follows:
  • Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
  • Transmural myocardial infarction within the last 6 months
  • Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
  • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days before registration
  • Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol
  • Acquired immune deficiency syndrome (AIDS) or human immunodeficiency virus (HIV) positive based upon current Centers for Disease and Control (CDC) definition; note, however, that HIV testing is not required for entry into this protocol; the need to exclude patients with AIDS or HIV from this protocol is necessary because anti-retrovirals may alter patient metabolism
  • Patient must not have active systemic lupus, erythematosus, or any history of scleroderma, dermatomyositis with active rash
  • No prior radiotherapy to the ipsilateral breast or prior radiation to the region of the breast that would result in overlap of radiation therapy fields
  • Patient may not have any active gastrointestinal/malabsorption disorder at the discretion of the Principal Investigator
  • Inflammatory bowel disease
  • Celiac disease
  • Chronic pancreatitis
  • Chronic diarrhea or vomiting
  • Active eating disorder
  • Creatinine < 1.7
  • Not currently taking steroids
  • No currently active pituitary secreting tumors up to physician discretion
  • No history of or current active drug/alcohol dependence
  • No patients being decisionally impaired

Who cannot join

  • Patient is not a candidate for breast conservation
  • Patient is male
  • Age < 18 years
  • Patient requires regional lymph node irradiation therapy
  • Patient has evidence of distant metastases
  • Karnofsky performance status less than 80% within 60 days prior to study
Show all 35Show fewer
  • Ipsilateral mammogram done greater than 6 months prior to study
  • Women of childbearing potential with a positive serum beta human chorionic gonadotropin (hCG)
  • Patient has a history of dementia, psychosis or other disorder affecting their mental status to the point where they cannot consent or comply with study guidelines
  • BMI < 21
  • Weight < 100 lbs
  • Weight loss >= 10% in the last 3 months (mos)
  • Prior invasive non-breast malignancy (except non-melanomatous skin cancer, carcinoma in situ of the cervix) unless disease free for a minimum of 2 years prior to registration
  • Two or more breast cancers not resectable through a single lumpectomy incision
  • Non-epithelial breast malignancies such as sarcoma or lymphoma
  • Prior radiotherapy to the ipsilateral breast or prior radiation to the region of the breast that would result in overlap of radiation therapy fields
  • Severe, active co-morbidity, defined as follows:
  • Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
  • Transmural myocardial infarction within the last 6 months
  • Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
  • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days before registration
  • Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol
  • Acquired immune deficiency syndrome (AIDS) or HIV positive based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol; the need to exclude patients with AIDS or HIV from this protocol is necessary because anti-retrovirals may alter patient metabolism
  • Active systemic lupus, erythematosus, or any history of scleroderma, dermatomyositis with active rash
  • Active gastrointestinal/malabsorption disorder at the discretion of the Principal Investigator
  • Inflammatory bowel disease
  • Celiac disease
  • Chronic pancreatitis
  • Chronic diarrhea or vomiting
  • Active eating disorder
  • Creatinine >= 1.7
  • Current use of steroids
  • Pituitary secreting tumors up to physician discretion
  • Active drug/alcohol dependence or abuse history
  • Decisionally impaired patients

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

Other trials in United States

About this study

Official title: A Feasibility Pilot Trial Evaluating Caloric Restriction for Oncology Research in Early Stage Breast Cancer Patients

This pilot clinical trial studies caloric restriction in patients with stage 0-I breast cancer during surgery and radiation therapy. Reducing caloric intake may prevent disease progression in patients with breast cancer. Radiation therapy uses high energy x rays to kill tumor cells. Giving dietary intervention and radiation therapy together may kill more tumor cells.

Read the detailed description

PRIMARY OBJECTIVE:

  1. Investigate the feasibility of a clinical trial administering ionizing radiation with concurrent caloric restriction (CR) for the treatment of breast cancer. SECONDARY OBJECTIVE:
  2. Investigate measurable changes of patient characteristics and tissue and serum from CR conditions to determine a metric for evaluating this treatment in future studies.

OUTLINE:

Beginning 2-4 weeks after completion of lumpectomy, patients receive food diaries to complete for 7-10 days. Dietary counselors then give patients guidelines for dietary modifications to reduce caloric intake by 25% of their normal diet. Patients follow caloric restricted diet for 10 weeks (2 weeks prior to radiation therapy, during 6 weeks of radiation therapy, and at least 2 weeks after radiation therapy). Patients undergo radiation therapy once daily (QD) 5 days a week for 6 weeks.

Being tested
Behavioral dietary intervention, Therapeutic conventional surgery, Radiation therapy, Counseling intervention, Quality-of-life assessment
Medical subject headings
Carcinoma, Intraductal, Noninfiltrating, Carcinoma, Ductal, Breast, Carcinoma, Lobular, Breast Carcinoma In Situ, Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Behavioral dietary interventionBehavioural

    Receive caloric restricted dietary intervention

  • Therapeutic conventional surgeryProcedure or surgery

    Undergo definitive lumpectomy

  • Radiation therapyRadiation

    Also called Irradiation, Radiotherapy, Radiation

    Undergo radiation therapy

  • Counseling interventionOther

    Also called Counseling and communications studies

    Receive dietary counseling

  • Quality-of-life assessmentProcedure or surgery

    Also called Quality of life assessment

    Ancillary studies

Study groups in NCT01819233
Study groupRoleWhat they receive
Behavioral dietary interventionExperimentalBeginning 2-4 weeks after completion of lumpectomy, patients receive food diaries to complete for 7-10 days. Dietary counselors then give patients guidelines for dietary modifications to reduce caloric intake by 25% of their normal diet. Patients follow caloric restricted diet for 10 weeks (2 weeks prior to radiation therapy, during 6 weeks of radiation therapy, and at least 2 weeks after radiation therapy). Patients undergo radiation therapy QD 5 days a week for 6 weeks.
Receives: Behavioral: Behavioral dietary intervention; Procedure: Therapeutic conventional surgery; Radiation: Radiation therapy; Other: Counseling intervention; Procedure: Quality-of-life assessment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants Who Are Adherent to the Diet Restriction

    Computed along with a 95% exact confidence interval. Exact binomial test (with a one-sided alpha of 0.05) will be used to test whether adherence is greater than 60%.

    Measured: Up to week 12

Secondary outcomes (9)

  1. Change in Body Fat Measurement

    Analyzed via a paired t-test. Change in body fat measurement as determined by the Durnin-Womersley 4-fold technique

    Measured: Baseline to 4 weeks after completion of study

  2. Change in Body Mass Index (BMI)

    Assessed via mixed-effects regression. Weight changes over time assessed by modeling BMI as a function of time

    Measured: Baseline to 4 weeks after completion of study

  3. Change in Heart Rate Over Time

    Assessed via mixed-effects regression.

    Measured: Baseline to 4 weeks after completion of study

  4. Patterns of Change Over Time in Serum Markers

    Assessed via mixed-effects regression.

    Measured: Baseline to 4 weeks after completion of study

  5. Patterns of Change Over Time in Psycho-social Outcomes Measured Using the Functional Assessment of Cancer Therapy-Breast (FACT-B)

    Assessed via mixed-effects regression. The FACT-B is a questionnaire using a 5-point Likert scale (0-Not at all to 4-Very much)

    Measured: Baseline to 4 weeks after completion of study

  6. Local Recurrence

    Analyzed via survival methods, specifically the Kaplan-Meier method and the logrank test.

    Measured: Up to 4 weeks after completion of study

  7. Distant Metastases

    Analyzed via survival methods, specifically the Kaplan-Meier method and the logrank test.

    Measured: Up to 4 weeks after completion of study

  8. Progression Free Survival

    Analyzed via survival methods, specifically the Kaplan-Meier method and the logrank test.

    Measured: Up to 4 weeks after completion of study

  9. Overall Survival

    Analyzed via survival methods, specifically the Kaplan-Meier method and the logrank test.

    Measured: Up to 4 weeks after completion of study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2013 (estimated)
  2. Study start8 Mar 2013
  3. Primary completion14 Sep 2017
  4. Study completionSep 2019

Resources

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 N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01819233
Sponsor's protocol ID
12G.616
Other IDs
2012-94, JT 3024, P30CA056036
Acronym
CAREFOR
Status last verified
Jun 2025
First submitted
22 Mar 2013
Last updated
6 Jun 2025
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Longo VD, Fontana L. Calorie restriction and cancer prevention: metabolic and molecular mechanisms. Trends Pharmacol Sci. 2010 Feb;31(2):89-98. doi: 10.1016/j.tips.2009.11.004. Epub 2010 Jan 25.

    PubMed 20097433

  • Hursting SD, Lavigne JA, Berrigan D, Perkins SN, Barrett JC. Calorie restriction, aging, and cancer prevention: mechanisms of action and applicability to humans. Annu Rev Med. 2003;54:131-52. doi: 10.1146/annurev.med.54.101601.152156. Epub 2001 Dec 3.

    PubMed 12525670

  • Rous P. THE INFLUENCE OF DIET ON TRANSPLANTED AND SPONTANEOUS MOUSE TUMORS. J Exp Med. 1914 Nov 1;20(5):433-51. doi: 10.1084/jem.20.5.433.

    PubMed 19867833

  • Tannenbaum A. Effects of Varying Caloric Intake Upon Tumor Incidence and Tumor Growth. Annals of the New York Academy of Sciences. 15 Dec 2006 2006;49(1).

  • Berrigan D, Perkins SN, Haines DC, Hursting SD. Adult-onset calorie restriction and fasting delay spontaneous tumorigenesis in p53-deficient mice. Carcinogenesis. 2002 May;23(5):817-22. doi: 10.1093/carcin/23.5.817.

    PubMed 12016155

  • Zhu Z, Jiang W, Thompson HJ. Effect of energy restriction on tissue size regulation during chemically induced mammary carcinogenesis. Carcinogenesis. 1999 Sep;20(9):1721-6. doi: 10.1093/carcin/20.9.1721.

    PubMed 10469616

  • Lok E, Scott FW, Mongeau R, Nera EA, Malcolm S, Clayson DB. Calorie restriction and cellular proliferation in various tissues of the female Swiss Webster mouse. Cancer Lett. 1990 May 15;51(1):67-73. doi: 10.1016/0304-3835(90)90232-m.

    PubMed 2337899

  • Grasl-Kraupp B, Bursch W, Ruttkay-Nedecky B, Wagner A, Lauer B, Schulte-Hermann R. Food restriction eliminates preneoplastic cells through apoptosis and antagonizes carcinogenesis in rat liver. Proc Natl Acad Sci U S A. 1994 Oct 11;91(21):9995-9. doi: 10.1073/pnas.91.21.9995.

    PubMed 7937932

  • Turner BC, Haffty BG, Narayanan L, Yuan J, Havre PA, Gumbs AA, Kaplan L, Burgaud JL, Carter D, Baserga R, Glazer PM. Insulin-like growth factor-I receptor overexpression mediates cellular radioresistance and local breast cancer recurrence after lumpectomy and radiation. Cancer Res. 1997 Aug 1;57(15):3079-83.

    PubMed 9242428

  • Perer ES, Madan AK, Shurin A, Zakris E, Romeguera K, Pang Y, Beech DJ. Insulin-like growth factor I receptor antagonism augments response to chemoradiation therapy in colon cancer cells. J Surg Res. 2000 Nov;94(1):1-5. doi: 10.1006/jsre.2000.5923.

    PubMed 11038295

  • Donohoe CL, Doyle SL, Reynolds JV. Visceral adiposity, insulin resistance and cancer risk. Diabetol Metab Syndr. 2011 Jun 22;3:12. doi: 10.1186/1758-5996-3-12.

    PubMed 21696633

  • Kahn SE, Hull RL, Utzschneider KM. Mechanisms linking obesity to insulin resistance and type 2 diabetes. Nature. 2006 Dec 14;444(7121):840-6. doi: 10.1038/nature05482.

    PubMed 17167471

  • Lee C, Safdie FM, Raffaghello L, Wei M, Madia F, Parrella E, Hwang D, Cohen P, Bianchi G, Longo VD. Reduced levels of IGF-I mediate differential protection of normal and cancer cells in response to fasting and improve chemotherapeutic index. Cancer Res. 2010 Feb 15;70(4):1564-72. doi: 10.1158/0008-5472.CAN-09-3228. Epub 2010 Feb 9.

    PubMed 20145127

  • Safdie F, Brandhorst S, Wei M, Wang W, Lee C, Hwang S, Conti PS, Chen TC, Longo VD. Fasting enhances the response of glioma to chemo- and radiotherapy. PLoS One. 2012;7(9):e44603. doi: 10.1371/journal.pone.0044603. Epub 2012 Sep 11.

    PubMed 22984531

  • National Institutes of Health. http://www.clincaltrials.gov.

Questions about this trial

What is this clinical trial studying?

A study testing Behavioral dietary intervention, Therapeutic conventional surgery and Radiation therapy in people with Ductal Breast Carcinoma in Situ and Invasive Ductal Breast Carcinoma, 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 34 inclusion and 35 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 6 Jun 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants Who Are Adherent to the Diet Restriction (time frame: Up to week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01819233, which also lists 16 linked publications.

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 6 Jun 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in