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CompletedNCT01819233CAREFORUpdated Jun 6, 2025Results posted

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

An interventional study of Behavioral dietary intervention and Therapeutic conventional surgery in Ductal Breast Carcinoma in Situ, Invasive Ductal Breast Carcinoma and Invasive Lobular Breast Carcinoma, sponsored by Sidney Kimmel Cancer Center at Thomas Jefferson University. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-06.

Sponsored by Sidney Kimmel Cancer Center at Thomas Jefferson University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
38
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study 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. 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.

02

Conditions studied

  • Ductal Breast Carcinoma in Situ
  • Invasive Ductal Breast Carcinoma
  • Invasive Lobular Breast Carcinoma
  • Lobular Breast Carcinoma in Situ
  • Recurrent Breast Cancer
  • Stage IA Breast Cancer
  • Stage IB Breast Cancer
03

In context

Carcinoma, Intraductal, Noninfiltrating

285 studies on the registry are indexed under Carcinoma, Intraductal, Noninfiltrating; 54 are open to participants now.

This study's enrollment of 38 is below the median of 66 across 207 interventional studies indexed under Carcinoma, Intraductal, Noninfiltrating.

Browse Carcinoma, Intraductal, Noninfiltrating studies →

Lead sponsor

Sidney Kimmel Cancer Center at Thomas Jefferson University is the lead sponsor of 120 studies on the registry; none are open to participants now.

Of its 23 completed or terminated interventional studies of FDA-regulated products, 7 (30%) have results posted.

Browse Sidney Kimmel Cancer Center at Thomas Jefferson University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. proven diagnosis of ductal carcinoma in situ (DCIS) or invasive breast cancer
  2. 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
  3. The patient must be female
  4. Age >= 18
  5. If multifocal breast cancer, then it must be able to be resected through a single lumpectomy incision

  6. Appropriate stage for protocol entry, including no clinical evidence for distant , based upon the following minimum diagnostic workup:

    1. History/physical examination, including breast exam and documentation of weight and performance status of 80-100% for at least 60 days prior to study entry
    2. Ipsilateral mammogram within 6 months prior to study entry
  7. Women of must have a negative serum pregnancy test within 14 days of study entry
  8. Women of childbearing potential must be non-pregnant and non-lactating and willing to use medically acceptable form of during radiation therapy
  9. Patient must capable of and provide study specific prior to study entry
  10. (BMI) >= 21
  11. Weight >= 100 lbs
  12. No prior history of non-breast in the past 2 years unless it was a non-melanomatous skin lesion or carcinoma in situ of the cervix

  13. Patient must not have any of the following severe, active co-morbidity, defined as follows:

    1. Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
    2. Transmural myocardial infarction within the last 6 months
    3. Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
    4. exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days before registration
    5. 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
    6. Acquired immune deficiency syndrome (AIDS) or (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
  14. Patient must not have active systemic lupus, erythematosus, or any history of scleroderma, dermatomyositis with active rash
  15. 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

  16. Patient may not have any active gastrointestinal/malabsorption disorder at the discretion of the Principal Investigator

    1. Inflammatory bowel disease
    2. Celiac disease
    3. Chronic pancreatitis
    4. Chronic diarrhea or vomiting
    5. Active eating disorder
  17. Creatinine \< 1.7
  18. Not currently taking
  19. No currently active pituitary secreting tumors up to physician discretion
  20. No history of or current active drug/alcohol dependence
  21. No patients being decisionally impaired

Exclusion criteria

Exclusion Criteria:

  1. Patient is not a candidate for breast conservation
  2. Patient is male
  3. Age \< 18 years
  4. Patient requires regional lymph node irradiation therapy
  5. Patient has evidence of distant
  6. performance status less than 80% within 60 days prior to study
  7. Ipsilateral mammogram done greater than 6 months prior to study
  8. Women of with a positive serum beta human chorionic gonadotropin (hCG)
  9. 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
  10. \< 21
  11. Weight \< 100 lbs
  12. Weight loss >= 10% in the last 3 months (mos)
  13. Prior invasive non-breast (except non-melanomatous skin cancer, carcinoma in situ of the cervix) unless disease free for a minimum of 2 years prior to registration
  14. Two or more breast cancers not resectable through a single lumpectomy incision
  15. Non-epithelial breast malignancies such as sarcoma or lymphoma
  16. Prior radiotherapy to the ipsilateral breast or prior radiation to the region of the breast that would result in overlap of radiation therapy fields

  17. Severe, active co-morbidity, defined as follows:

    1. Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
    2. Transmural myocardial infarction within the last 6 months
    3. Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
    4. exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days before registration
    5. 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
    6. Acquired immune deficiency syndrome (AIDS) or 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
  18. Active systemic lupus, erythematosus, or any history of scleroderma, dermatomyositis with active rash

  19. Active gastrointestinal/malabsorption disorder at the discretion of the Principal Investigator

    1. Inflammatory bowel disease
    2. Celiac disease
    3. Chronic pancreatitis
    4. Chronic diarrhea or vomiting
    5. Active eating disorder
  20. Creatinine >= 1.7
  21. Current use of
  22. Pituitary secreting tumors up to physician discretion
  23. Active drug/alcohol dependence or abuse history
  24. Decisionally impaired patients
Terms in these criteria, in plain language(11)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Karnofsky performance status (KPS)

A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.

Studies often ask for 60 or 70 and above. Your doctor gives the score.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
38 participants (actual)

Study arms

  • Experimental
    Behavioral dietary intervention

    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 QD 5 days a week for 6 weeks.

    Behavioral: Behavioral dietary intervention · Procedure: Therapeutic conventional surgery · Radiation: Radiation therapy · Other: Counseling intervention · Procedure: Quality-of-life assessment

Interventions

  • BehavioralBehavioral dietary intervention

    Receive caloric restricted dietary intervention

  • ProcedureTherapeutic conventional surgery

    Undergo definitive lumpectomy

  • RadiationRadiation therapy

    Undergo radiation therapy

    Also known as: Irradiation, Radiotherapy, Radiation

  • OtherCounseling intervention

    Receive dietary counseling

    Also known as: Counseling and communications studies

  • ProcedureQuality-of-life assessment

    Ancillary studies

    Also known as: Quality of life assessment

06

What researchers measure

Primary outcomes

  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%.

    Time frame: Up to week 12

Secondary outcomes

  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

    Time frame: 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

    Time frame: Baseline to 4 weeks after completion of study

  3. Change in Heart Rate Over Time

    Assessed via mixed-effects regression.

    Time frame: Baseline to 4 weeks after completion of study

  4. Patterns of Change Over Time in Serum Markers

    Assessed via mixed-effects regression.

    Time frame: 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)

    Time frame: Baseline to 4 weeks after completion of study

  6. Local Recurrence

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

    Time frame: Up to 4 weeks after completion of study

  7. Distant Metastases

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

    Time frame: 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.

    Time frame: Up to 4 weeks after completion of study

  9. Overall Survival

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

    Time frame: Up to 4 weeks after completion of study

07

Results

Posted Dec 23, 2019

Participant flow

Participant flow — Overall Study
MilestoneBehavioral Dietary Intervention
Started38
Completed32
Not completed6

Outcome measures

PrimaryNumber 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%.

Time frame:
Up to week 12
Reported as:
Number · participants
Number of Participants Who Are Adherent to the Diet Restriction
participantsBehavioral Dietary Intervention
Number of Participants Who Are Adherent to the Diet Restriction28 (NA to 74.5)
SecondaryChange in Body Fat Measurement

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

Time frame:
Baseline to 4 weeks after completion of study
Reported as:
Mean · percentage of change in body fat
Change in Body Fat Measurement
percentage of change in body fatBehavioral Dietary Intervention
Change in Body Fat Measurement-3.1 (-4.7 to -1.5)
SecondaryChange in Body Mass Index (BMI)

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

Time frame:
Baseline to 4 weeks after completion of study
Reported as:
Mean · percentage of change in BMI
Change in Body Mass Index (BMI)
percentage of change in BMIBehavioral Dietary Intervention
Change in Body Mass Index (BMI)-1.2 (-1.6 to -0.8)
SecondaryChange in Heart Rate Over Time

Assessed via mixed-effects regression.

Time frame:
Baseline to 4 weeks after completion of study
Reported as:
Mean · beats per minute
Change in Heart Rate Over Time
beats per minuteBehavioral Dietary Intervention
Change in Heart Rate Over Time67.3 ± 1.5
SecondaryPatterns of Change Over Time in Serum Markers

Assessed via mixed-effects regression.

Time frame:
Baseline to 4 weeks after completion of study

Results for this outcome have not been posted.

SecondaryPatterns 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)

Time frame:
Baseline to 4 weeks after completion of study
Reported as:
Mean · score on a scale
Patterns of Change Over Time in Psycho-social Outcomes Measured Using the Functional Assessment of Cancer Therapy-Breast (FACT-B)
score on a scaleBehavioral Dietary Intervention
Patterns of Change Over Time in Psycho-social Outcomes Measured Using the Functional Assessment of Cancer Therapy-Breast (FACT-B)0.8 (-6.2 to 7.8)
SecondaryLocal Recurrence

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

Time frame:
Up to 4 weeks after completion of study
Reported as:
Count of participants · Participants
Local Recurrence
ParticipantsBehavioral Dietary Intervention
Local RecurrenceNA
SecondaryDistant Metastases

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

Time frame:
Up to 4 weeks after completion of study
Reported as:
Count of participants · Participants
Distant Metastases
ParticipantsBehavioral Dietary Intervention
Distant MetastasesNA
SecondaryProgression Free Survival

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

Time frame:
Up to 4 weeks after completion of study
Reported as:
Count of participants · Participants
Progression Free Survival
ParticipantsBehavioral Dietary Intervention
Progression Free SurvivalNA
SecondaryOverall Survival

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

Time frame:
Up to 4 weeks after completion of study
Reported as:
Count of participants · Participants
Overall Survival
ParticipantsBehavioral Dietary Intervention
Overall SurvivalNA

Adverse events

Collected over baseline through 5 weeks after completion of study diet.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Behavioral Dietary Intervention0/38 (0%)0/38 (0%)14/38 (36.8%)
Most frequent other events
Most frequent other events
EventBehavioral Dietary Intervention
DermatitisSkin and subcutaneous tissue disorders13/38
fatigueGeneral disorders13/38
hyperpigmentationSkin and subcutaneous tissue disorders10/38
hot flashesGeneral disorders5/38

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Behavioral Dietary Intervention
<=18 years0
Between 18 and 65 years33
>=65 years5
Sex: Female, Male
Sex: Female, Male(Participants)Behavioral Dietary Intervention
Female38
Male0
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Behavioral Dietary Intervention
Hispanic or Latino4
Not Hispanic or Latino33
Unknown or Not Reported1
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Behavioral Dietary Intervention
American Indian or Alaska Native0
Asian1
Native Hawaiian or Other Pacific Islander0
Black or African American15
White18
More than one race0
Unknown or Not Reported4
Region of Enrollment
Region of Enrollment(participants)Behavioral Dietary Intervention
United States38
08

Study locations

1 site
  • Thomas Jefferson University
    Philadelphia, Pennsylvania 19107, United States
09

References and documents

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.
  • Arguin H, Dionne IJ, Senechal M, Bouchard DR, Carpentier AC, Ardilouze JL, Tremblay A, Leblanc C, Brochu M. Short- and long-term effects of continuous versus intermittent restrictive diet approaches on body composition and the metabolic profile in overweight and obese postmenopausal women: a pilot study. Menopause. 2012 Aug;19(8):870-6. doi: 10.1097/gme.0b013e318250a287. PubMed 22735163 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 6, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01819233
Lead sponsor
Sidney Kimmel Cancer Center at Thomas Jefferson University
Responsible party
Sponsor
First posted
Mar 27, 2013
Start date
Mar 8, 2013
Primary completion
Sep 14, 2017
Completion
Sep 2019
Results posted
Dec 23, 2019
Last update
Jun 6, 2025

Study contacts

Nicole Simone, MD
principal investigator · Thomas Jefferson University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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