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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Thomas Jefferson University
Sponsor:
Collaborator:
Ladies of Port Richmond
Information provided by (Responsible Party):
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT01819233
First received: March 22, 2013
Last updated: February 18, 2014
Last verified: February 2014
  Purpose

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.


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

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Feasibility Pilot Trial Evaluating Caloric Restriction for Oncology Research in Early Stage Breast Cancer Patients

Resource links provided by NLM:


Further study details as provided by Thomas Jefferson University:

Primary Outcome Measures:
  • Proportion of patients who are adherent to the diet restriction [ Time Frame: Up to week 12 ] [ Designated as safety issue: No ]
    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%.


Secondary Outcome Measures:
  • Change in body fat measurement as determined by the Durnin-Womersley 4-fold technique [ Time Frame: Baseline to 4 weeks after completion of study ] [ Designated as safety issue: No ]
    Analyzed via a paired t-test.

  • Weight changes over time assessed by modeling BMI as a function of time [ Time Frame: Baseline to 4 weeks after completion of study ] [ Designated as safety issue: No ]
    Assessed via mixed-effects regression.

  • Patterns of change over time in vital signs, insulin and other clinical labs [ Time Frame: Baseline to 4 weeks after completion of study ] [ Designated as safety issue: No ]
    Assessed via mixed-effects regression.

  • Patterns of change over time in serum markers [ Time Frame: Baseline to 4 weeks after completion of study ] [ Designated as safety issue: No ]
    Assessed via mixed-effects regression.

  • Patterns of change over time in psycho-social outcomes measured using the Functional Assessment of Cancer Therapy-Breast (FACT-B) [ Time Frame: Baseline to 4 weeks after completion of study ] [ Designated as safety issue: No ]
    Assessed via mixed-effects regression.

  • Local recurrence [ Time Frame: Up to 4 weeks after completion of study ] [ Designated as safety issue: No ]
    Analyzed via survival methods, specifically the Kaplan-Meier method and the logrank test.

  • Distant metastases [ Time Frame: Up to 4 weeks after completion of study ] [ Designated as safety issue: No ]
    Analyzed via survival methods, specifically the Kaplan-Meier method and the logrank test.

  • Progression free survival [ Time Frame: Up to 4 weeks after completion of study ] [ Designated as safety issue: No ]
    Analyzed via survival methods, specifically the Kaplan-Meier method and the logrank test.

  • Overall survival [ Time Frame: Up to 4 weeks after completion of study ] [ Designated as safety issue: No ]
    Analyzed via survival methods, specifically the Kaplan-Meier method and the logrank test.


Estimated Enrollment: 40
Study Start Date: March 2013
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Receive caloric restricted dietary intervention
Procedure: Therapeutic conventional surgery
Undergo definitive lumpectomy
Radiation: Radiation therapy
Undergo radiation therapy
Other Names:
  • Irradiation
  • Radiotherapy
  • Radiation
Other: Counseling intervention
Receive dietary counseling
Other Name: Counseling and communications studies
Procedure: Quality-of-life assessment
Ancillary studies
Other Name: Quality of life assessment

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Pathologically 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
  3. The patient must be female
  4. Age >= 18
  5. Clinical (c)Stage 0 or cStage I
  6. If multifocal breast cancer, then it must have been resected through a single lumpectomy incision with negative margins
  7. Appropriate stage for protocol entry, including no clinical evidence for distant metastases, based upon the following minimum diagnostic workup:

    1. 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
    2. Ipsilateral mammogram within 6 months prior to study entry
  8. Women of childbearing potential must have a negative serum pregnancy test within 14 days of study entry
  9. Women of childbearing potential must be non-pregnant and non-lactating and willing to use medically acceptable form of contraception during radiation therapy
  10. Patient must capable of and provide study specific informed consent prior to study entry
  11. Body mass index (BMI) >= 21
  12. Weight >= 100 lbs
  13. No prior history of non-breast malignancies in the past 5 years unless it was a non-melanomatous skin lesion or carcinoma in situ of the cervix
  14. Patient must not be a candidate to receive chemotherapy
  15. 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. Chronic obstructive pulmonary disease 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 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
  16. Patient must not have active systemic lupus, erythematosus, or any history of scleroderma, dermatomyositis with active rash
  17. 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
  18. Patient must have a fasting glucose < 125 mg/mL and not be currently taking hypoglycemic medications
  19. 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
  20. Creatinine < 1.7
  21. Not currently taking steroids
  22. No currently active pituitary secreting tumors up to physician discretion
  23. No history of or current active drug/alcohol dependence
  24. No patients being decisionally impaired

Exclusion Criteria:

  1. Patient is not a candidate for breast conservation
  2. Patient is male
  3. Age < 18 years
  4. cStage II or above
  5. Patient has evidence of distant metastases
  6. Karnofsky 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 childbearing potential 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. BMI < 21
  11. Weight < 100 lbs
  12. Weight loss >= 10% in the last 3 months (mos)
  13. Prior invasive non-breast malignancy (except non-melanomatous skin cancer, carcinoma in situ of the cervix) unless disease free for a minimum of 5 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. Intention to administer concurrent chemotherapy for current breast cancer
  18. 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. Chronic obstructive pulmonary disease 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 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
  19. Active systemic lupus, erythematosus, or any history of scleroderma, dermatomyositis with active rash
  20. Fasting glucose > 125 or currently taking hypoglycemic medications
  21. 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
  22. Creatinine >= 1.7
  23. Current use of steroids
  24. Pituitary secreting tumors up to physician discretion
  25. Active drug/alcohol dependence or abuse history
  26. Decisionally impaired patients
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01819233

Contacts
Contact: Nicole Simone, MD 215-955-8619
Contact: Radiation Oncology Protocol Office 215-955-8619

Locations
United States, Pennsylvania
Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Nicole Simone, MD         
Contact: Radiation Oncology Protocol Office    215-955-8619      
Principal Investigator: Nicole Simone, MD         
Sub-Investigator: Daniel Monti, MD         
Sub-Investigator: Pramila Rani Anne, MD         
Sub-Investigator: Maria Werner-Wasik, MD         
Sub-Investigator: Adam Dicker, MD, PhD         
Sub-Investigator: Wenyin Shi, MD, PhD         
Sub-Investigator: Voichita Bar-Ad, MD         
Sub-Investigator: Robert Den, MD         
Sub-Investigator: Anne Rosenberg, MD         
Sub-Investigator: Adam Berger, MD         
Sub-Investigator: Gordon Schwartz, MD         
Sub-Investigator: Andrew Newberg, MD         
Sponsors and Collaborators
Thomas Jefferson University
Ladies of Port Richmond
Investigators
Principal Investigator: Nicole Simone, MD Thomas Jefferson University
  More Information

Additional Information:
Publications:

Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT01819233     History of Changes
Other Study ID Numbers: 12G.616, 2012-94
Study First Received: March 22, 2013
Last Updated: February 18, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Carcinoma, Ductal, Breast
Breast Neoplasms
Carcinoma
Carcinoma in Situ
Carcinoma, Intraductal, Noninfiltrating
Carcinoma, Lobular
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Adenocarcinoma
Neoplasms, Ductal, Lobular, and Medullary
Carcinoma, Ductal

ClinicalTrials.gov processed this record on July 24, 2014