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

NCT ID: NCT02827370

Last Updated: 2025-04-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-16
• Study Completion Date: 2019-12-15

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.

Conditions

Breast Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Behavioral Dietary Intervention

Intervention Type: BEHAVIORAL

Receive dietary counseling

Interventions

Behavioral Dietary Intervention

Receive dietary counseling

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Sidney Kimmel Cancer Center at Thomas Jefferson University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nicole Simone, MD

Role: PRINCIPAL_INVESTIGATOR

Thomas Jefferson University

Locations

Sidney Kimmel Cancer Center at Thomas Jefferson Univeristy

Philadelphia, Pennsylvania, United States

Countries

United States

Related Links

http://hospitals.jefferson.edu/

Thomas Jefferson University Hospital

Other Identifiers

JT 8562

Identifier Type: OTHER

Identifier Source: secondary_id

16D.067

Identifier Type: -

Identifier Source: org_study_id