Clinical trial NCT02827370: CAREFOR: Precision Medicine Driving Precision Nutrition for the Treatment of NeoAdjuvant Breast Cancer
Official title: CAREFOR Study: Precision Nutrition Caloric Restriction for Oncology Research: Precision Medicine Driving Precision Nutrition During Neoadjuvant Chemotherapy for Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Carcinoma
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2016-07-11
Enrollment: 26
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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.

Eligibility 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.

Primary outcomes:
measure: Pathologic complete response assessed in tissue
timeFrame: At time of definitive breast surgery
measure: Incidence of adverse events evaluated by CTCAE version 4.0
timeFrame: Up to 24 months
Secondary outcomes:
measure: Number of study participants who receive the dietary intervention to the historical controls
timeFrame: Up to 24 months
measure: Weight changes
timeFrame: Up to 24 months
measure: Change in insulin
timeFrame: Up to 24 months
measure: Change in serum
timeFrame: Up to 24 months
measure: Distant metastases
timeFrame: Up to 24 months
measure: Progression-free survival
timeFrame: Up to 24 months
measure: Overall survival
timeFrame: Up to 24 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Sidney Kimmel Cancer Center at Thomas Jefferson Univeristy
state: Pennsylvania
Study officials:
affiliation: Thomas Jefferson University
name: Nicole Simone, MD
role: PRINCIPAL_INVESTIGATOR
References: