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CAREFOR: Precision Medicine Driving Precision Nutrition for the Treatment of NeoAdjuvant Breast Cancer

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ClinicalTrials.gov Identifier: NCT02827370
Recruitment Status : Recruiting
First Posted : July 11, 2016
Last Update Posted : August 21, 2018
Sponsor:
Information provided by (Responsible Party):
Thomas Jefferson University ( Sidney Kimmel Cancer Center at Thomas Jefferson University )

Brief Summary:
The purpose of the study is to determine if a targeted dietary change can enhance the effect of neo-adjuvant chemotherapy

Condition or disease Intervention/treatment Phase
Breast Carcinoma Behavioral: Behavioral Dietary Intervention Not Applicable

Detailed Description:

Primary objective:

I To determine if dietary alternations designed to downregulate the dominate molecular drivers of an individuals' breast cancer will enhance the effect of neoadjuvant chemotherapy and allow for an increase in the pathologic complete response rate.

Secondary objectives

I) Investigator measurable changes to molecular and patient characteristics from precision nutrition to determine a metric for evaluation this treatment in future studies.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CAREFOR Study: Precision Nutrition Caloric Restriction for Oncology Research: Precision Medicine Driving Precision Nutrition During Neoadjuvant Chemotherapy for Breast Cancer
Actual Study Start Date : June 16, 2016
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Precision Nutrition (dietary intervention)
During chemotherapy, patients will receive dietary counseling based on the molecular pathways driving their specific breast cancers found through genetic testing. Nutritional recommendations will seek to down-regulate the dominant molecular drivers of an individual's breast cancer while they are receiving standard chemotherapy as outlined by their treating medical oncologist.
Behavioral: Behavioral Dietary Intervention
Receive dietary counseling




Primary Outcome Measures :
  1. Pathologic complete response assessed in tissue [ Time Frame: At time of definitive breast surgery ]
    The portion of patients who adhere to the diet restriction will be computed along with a 95% exact confidence. An exact binomial test (with a onesided alpha of 0.05) will also be used to test whether adherence is greater than 60%.

  2. Incidence of adverse events evaluated by CTCAE version 4.0 [ Time Frame: Up to 24 months ]

Secondary Outcome Measures :
  1. Number of study participants who receive the dietary intervention to the historical controls [ Time Frame: Up to 24 months ]
    Will be compared to historical controls. Will be based on logistic regression, which will control for patient characteristics and clinical factors. The study has 81% power to detect an odds ratio of about 0.25 using a 2-sided alpha of 0.05

  2. Weight changes [ Time Frame: Up to 24 months ]
    Will be assessed by modeling body mass index as a function of time via mixed-effects regression.

  3. Change in insulin [ Time Frame: Up to 24 months ]
    Will be assessed as a function of time via mixed-effects regression.

  4. Change in serum [ Time Frame: Up to 24 months ]
    Will be assessed as a function of time via mixed-effects regression.

  5. Distant metastases [ Time Frame: Up to 24 months ]
    Will be analyzed via the Kaplan-Meier method and the logrank test.

  6. Progression-free survival [ Time Frame: Up to 24 months ]
    Kaplan-Meier curves will be generated and a log-rank value will be calculated.

  7. Overall survival [ Time Frame: Up to 24 months ]
    Will be analyzed with the Kaplan-Meier method and Cox proportional hazards regression.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pathologically proven invasive breast cancer
  • Planned neoadjuvant chemotherapy determined by the judgment of the medical oncologist
  • The patient must be female
  • Age ≥ 18
  • Non-metastatic and non-inflammatory breast cancer
  • 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.
  • Women of childbearing potential must be non-pregnant and non-lactating and willing to use medically acceptable form of contraception during chemotherapy
  • Patient must capable of and provide study specific informed consent prior to study entry
  • BMI ≥21
  • Weight ≥120lbs
  • No prior history of non-breast malignancies in the past 1 year unless it was a non- melanomatous skin lesion or carcinoma in situ of the cervix.
  • Patient must not have 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.
  • Patient may not have any active Gastrointestinal/Malabsorption disorder at the discretion of the Principal Investigator which may include:
  • Chronic Pancreatitis
  • Chronic Diarrhea or Vomiting
  • Active Eating Disorder
  • No history of or current active drug/alcohol dependence.
  • No patients with decisional impairment.

Exclusion Criteria:

  • Patient is male.
  • Age <18 years
  • Clinical stage IV cancer
  • Inflammatory breast cancer (T4d)
  • Women of childbearing potential with a positive serum beta hCG.
  • Decision impaired patients.
  • BMI < 21
  • Weight < 120lbs
  • Weight loss ≥10% in the last 3 mos
  • Prior invasive non-breast malignancy (except non-melanomatous skin cancer, carcinoma in situ of the cervix) unless disease free for a minimum of 1 year prior to registration
  • Non-epithelial breast malignancies such as sarcoma or lymphoma
  • Active Gastrointestinal/Malabsorption disorder at the discretion of the Principal -Investigator which may include:

    • Chronic Diarrhea or Vomiting
    • Active Eating Disorder
    • Active drug/alcohol dependence or abuse history.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02827370


Contacts
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Contact: Nicole Simone, MD 215-955-6702

Locations
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United States, Pennsylvania
Sidney Kimmel Cancer Center at Thomas Jefferson Univeristy Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Nicole Simone, MD         
Sponsors and Collaborators
Sidney Kimmel Cancer Center at Thomas Jefferson University
Investigators
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Principal Investigator: Nicole Simone, MD Thomas Jefferson University

Additional Information:
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Responsible Party: Sidney Kimmel Cancer Center at Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT02827370     History of Changes
Other Study ID Numbers: 16D.067
First Posted: July 11, 2016    Key Record Dates
Last Update Posted: August 21, 2018
Last Verified: August 2018

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases