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

CAREFOR Study: Precision Nutrition Caloric Restriction for Oncology Research: Precision Medicine Driving Precision Nutrition During Neoadjuvant Chemotherapy for Breast Cancer

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

Study Overview

• Status: Completed
• Conditions: Breast Carcinoma
• Intervention / Treatment: Behavioral: Behavioral Dietary Intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Sidney Kimmel Cancer Center at Thomas Jefferson Univeristy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pathologic complete response assessed in tissue	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%.	At time of definitive breast surgery
Incidence of adverse events evaluated by CTCAE version 4.0		Up to 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of study participants who receive the dietary intervention to the historical controls	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	Up to 24 months
Weight changes	Will be assessed by modeling body mass index as a function of time via mixed-effects regression.	Up to 24 months
Change in insulin	Will be assessed as a function of time via mixed-effects regression.	Up to 24 months
Change in serum	Will be assessed as a function of time via mixed-effects regression.	Up to 24 months
Distant metastases	Will be analyzed via the Kaplan-Meier method and the logrank test.	Up to 24 months
Progression-free survival	Kaplan-Meier curves will be generated and a log-rank value will be calculated.	Up to 24 months
Overall survival	Will be analyzed with the Kaplan-Meier method and Cox proportional hazards regression.	Up to 24 months

Collaborators and Investigators

• Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University
• Investigators: Principal Investigator: Nicole Simone, MD, Thomas Jefferson University

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2016
• Primary Completion (Actual): July 1, 2019
• Study Completion (Actual): December 15, 2019

Study Registration Dates

• First Submitted: June 13, 2016
• First Submitted That Met QC Criteria: July 6, 2016
• First Posted (Estimated): July 11, 2016

Study Record Updates

• Last Update Posted (Actual): July 17, 2023
• Last Update Submitted That Met QC Criteria: July 14, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 16D.067