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

Status: Completed
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Pennsylvania
Sidney Kimmel Cancer Center at Thomas Jefferson Univeristy
Philadelphia
Time Frame
Start Date: 2016-06-16
Completion Date: 2019-12-15
Participants
Target number of participants: 26
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Sidney Kimmel Cancer Center at Thomas Jefferson University

This content was sourced from clinicaltrials.gov

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