Clinical Trial: NCT03822715 - My Cancer Genome

NCT03822715

Description:

This is a feasibility trial of a 6-month extreme carbohydrate restricted diet (20 grams total carbs/day) via counseling with dietitian plus aromatase inhibitor therapy. Visits will occur at screening, mid-study, and pre-surgery. Anthropomorphic measurements, and patient reported outcomes (PROs) will be taken at all three visits. Patients will speak with a dietitian at their monthly standard of care visits, and will receive weekly calls for the first 4 weeks of the intervention. All subjects will receive surgery after approximately 6 months of intervention. Total duration of the study is expected to be 2 years, though each patient's participation will be approximately 6 months.

Related Conditions:

Breast Carcinoma

Recruiting Status:

Recruiting

Phase:

Phase 1

URL:

https://clinicaltrials.gov/show/NCT03822715

Trial Eligibility

Document

Title

Brief Title: NEOBREADS: Neoadjuvant Breast Diet Study
Official Title: IIT2018-25-MITA-NEOBREADS: Neoadjuvant Breast Diet Study

Clinical Trial IDs

ORG STUDY ID: IIT2018-25-MITA-NEOBREADS
NCT ID: NCT03822715

Conditions

Breast Cancer

Interventions

Drug	Synonyms	Arms
standard of care aromatase inhibitors		Dietary intervention

Purpose

Trial Arms

Name	Type	Description	Interventions
Dietary intervention	Experimental	Carbohydrate restricted dietary intervention (<20 g carbohydrates/day) + standard of care aromatase inhibitors	standard of care aromatase inhibitors

Eligibility Criteria

        Inclusion Criteria:

          -  Histologically confirmed breast cancer; clinical T2-T4c, any N, M0 invasive breast
             cancer by AJCC 7th edition clinical staging, with goal being surgery to complete
             excision of tumor in the breast and lymph node. Primary tumor must be palpable,
             largest diameter >2.0 cm by physical examination or by radiological assessment.

          -  ER/PR+; defined as either ER and/or PR +, 1+ in 10% of cells

          -  HER2 Negative; HER2 negative is defined by the following criteria:

               1. 0 or 1+ by IHC and ISH not done

               2. 0 or 1+ by IHC or ISH ratio (HER2 gene copy/chromosome 17) < 2

               3. 2+ by IHC and ISH ratio (HER2 gene copy/chromosome 17) < 2

          -  Ability to read, write, and understand English

          -  BMI >24 kg/m2

          -  ECOG performance status 0-2

          -  Planning to receive neoadjuvant aromatase inhibitor therapy

          -  Written informed consent obtained from subject and ability for subject to comply with
             the requirements of the study.

          -  Age > 18 years

        Exclusion Criteria:

          -  Already consuming a severely carbohydrate-restricted (i.e. <20g total carbohydrates
             per day) or vegetarian diet

          -  Medical comorbidities that in the opinion of the investigator limits the patient's
             ability to complete this study

          -  Candidate for chemotherapy or HER2 directed therapy

          -  Treatment for this cancer including surgery, radiation therapy, chemotherapy,
             biotherapy, hormonal therapy, or investigational agent prior to study entry
             (initiation of AI within 30 days of diet initiation acceptable)

          -  Loss of >10% of body weight within the previous 6 months

          -  Clinical or radiographic evidence of metastatic disease.

          -  Current use of weight loss medications including herbal weight loss supplements or
             enrolled in a diet/weight loss program

Maximum Eligible Age:	N/A
Minimum Eligible Age:	18 Years
Eligible Gender:	Female
Healthy Volunteers:	No

Primary Outcome Measures

Measure:	Diet adherence
Time Frame:	6 months
Safety Issue:
Description:	Proportion of patients able to consistently adhere to the low carbohydrate diet in combination with AIs during neo-adjuvant treatment. The patient will be considered adherent for each food diary if <20% of calories were obtained from carbohydrates. This will be approximately 80 grams of carbohydrates but will vary depending on total caloric intake. A patient will be considered adherent to the diet overall if they meet the adherence cutoff at least 75% of the time (i.e. in at least 75% of food diaries for a single patient <20% of calories were obtained from carbohydrates).

Secondary Outcome Measures

Measure:	Change in tumor size
Time Frame:	6 months
Safety Issue:
Description:	Difference in change in tumor size between pre- and post-intervention between carbohydrate restricted and control group.

Measure:	Mean change in Ki67
Time Frame:	6 months
Safety Issue:
Description:	Change in Ki67 between pre-and post- intervention

Measure:	Mean change in weight
Time Frame:	6 months
Safety Issue:
Description:	Change in weight between pre- and post- intervention

Measure:	Mean change in HbA1c
Time Frame:	6 months
Safety Issue:
Description:	Change in HbA1c between pre- and post- intervention

Measure:	Mean change in insulin
Time Frame:	6 months
Safety Issue:
Description:	Change in insulin between pre- and post- intervention

Measure:	Mean change in triglycerides
Time Frame:	6 months
Safety Issue:
Description:	Change in triglycerides between pre- and post- intervention

Measure:	Mean change in LDL cholesterol
Time Frame:	6 months
Safety Issue:
Description:	Change in LDL cholesterol between pre- and post- intervention

Measure:	Mean change in HDL cholesterol
Time Frame:	6 months
Safety Issue:
Description:	Change in HDL cholesterol between pre- and post- intervention

Measure:	Mean change in total cholesterol
Time Frame:	6 months
Safety Issue:
Description:	Change in total cholesterol between pre- and post- intervention

Details

Phase:	Phase 1
Primary Purpose:	Interventional
Overall Status:	Recruiting
Lead Sponsor:	Monica Mita

Trial Keywords

aromatase inhibitor
carbohydrate restricted diet
neo-adjuvant treatment
low-carb diet
low carb diet

Last Updated

March 26, 2021

Clinical Trials /

NEOBREADS: Neoadjuvant Breast Diet Study