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

NCT01819233 | Completed Results DMC

• 4 other identifiers: 12G.6162012-94JT 3024P30CA056036
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

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%.

  Up to week 12

Secondary Outcomes (9)

• Change in Body Fat Measurement

  Baseline to 4 weeks after completion of study

• Change in Body Mass Index (BMI)

  Baseline to 4 weeks after completion of study

• Change in Heart Rate Over Time

  Baseline to 4 weeks after completion of study

• Patterns of Change Over Time in Serum Markers

  Baseline to 4 weeks after completion of study

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

  Baseline to 4 weeks after completion of study

Study Arms (1)

Behavioral dietary intervention

EXPERIMENTAL

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

Behavioral dietary intervention BEHAVIORAL

Receive caloric restricted dietary intervention

Behavioral dietary intervention

Therapeutic conventional surgery PROCEDURE

Undergo definitive lumpectomy

Behavioral dietary intervention

Radiation therapy RADIATION

Undergo radiation therapy

Also known as: Irradiation, Radiotherapy, Radiation

Behavioral dietary intervention

Counseling intervention OTHER

Receive dietary counseling

Also known as: Counseling and communications studies

Behavioral dietary intervention

Quality-of-life assessment PROCEDURE

Ancillary studies

Also known as: Quality of life assessment

Behavioral dietary intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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:

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Sidney Kimmel Cancer Center at Thomas Jefferson University: lead

Study Sites (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (16)

• 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.

  PMID: 20097433 BACKGROUND

• 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.

  PMID: 12525670 BACKGROUND

• 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.

  PMID: 19867833 BACKGROUND

• 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).

  BACKGROUND

• 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.

  PMID: 12016155 BACKGROUND

• 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.

  PMID: 10469616 BACKGROUND

• 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.

  PMID: 2337899 BACKGROUND

• 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.

  PMID: 7937932 BACKGROUND

• 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.

  PMID: 9242428 BACKGROUND

• 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.

  PMID: 11038295 BACKGROUND

• 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.

  PMID: 21696633 BACKGROUND

• 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.

  PMID: 17167471 BACKGROUND

• 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.

  PMID: 20145127 BACKGROUND

• 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.

  PMID: 22984531 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 22735163 BACKGROUND

Related Links

• Kimmel Cancer Center at Thomas Jefferson University, an NCI-Designated Cancer Center
• Thomas Jefferson University Hospitals

MeSH Terms

Conditions

Carcinoma, Intraductal, Noninfiltrating; Carcinoma, Ductal, Breast; Carcinoma, Lobular; Breast Carcinoma In Situ; Breast Neoplasms

Interventions

Radiotherapy; Radiation; Counseling

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Carcinoma in Situ; Neoplasms, Ductal, Lobular, and Medullary; Carcinoma, Ductal; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Physical Phenomena; Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Dr. Nicole Simone
• Organization: Sidney Kimmel Cancer Center at Thomas Jefferson University

nicole.simone@jefferson.edu

215-955-6702

Study Officials

• Nicole Simone, MD

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2013
• First Posted: March 27, 2013
• Study Start: March 8, 2013
• Primary Completion: September 14, 2017
• Study Completion: September 1, 2019
• Last Updated: June 6, 2025
• Results First Posted: December 23, 2019

Record last verified: 2025-06

Locations

US (1)