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Lifestyle, Exercise, And Nutrition (LEAN) Trial on Pathologic Complete Response in TNBC

Lifestyle, Exercise, And Nutrition (LEAN) Trial on Pathologic Complete Response in Triple Negative Breast Cancer (TNBC)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Blood draws, X-rays, Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Study activities include completing surveys and attending two in-person study visits, each of which will include a blood draw, a 6-minute walk test to assess aerobic capacity and endurance, and a Dual Energy X-Ray Absorptiometry (DXA) scan to measure body composition."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether a food and exercise program helps women with triple-negative breast cancer have no cancer seen in the breast after chemotherapy. It is for women with stage II or III cancer who will get chemotherapy and immune therapy before surgery.

The purpose of this study is to examine whether a nutrition and exercise program can improve pathologic complete response (pCR) in women with triple-negative breast cancer (TNBC) receiving chemo-immunotherapy before surgery. Pathologic complete (pCR) response means that no cancer in the breast is seen after chemotherapy.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be a woman age 18 or older with stage II or III triple-negative breast cancer.
  • Be scheduled to get chemotherapy and immune therapy before surgery.
  • Be physically able to walk.
  • Be able to read English, understand instructions, and fill out forms.
  • Agree to be placed in either study group by chance.
  • Have your cancer doctor's approval to take part.
  • Exercise less than 150 minutes per week.
  • Eat no more than 7 fruits and vegetables per day.

Who can't join

  • Have already started your second round of chemotherapy.
  • Be pregnant or plan to become pregnant.
  • Have dementia, which affects memory and thinking, or a major mental illness.
  • Have had a stroke, heart attack, or congestive heart failure in the past year. Heart failure means the heart does not pump blood well.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 1. Female aged 18 years or older. 2. Have a diagnosis of stage II or III Triple Negative Breast Cancer (TNBC). 3. Be scheduled to receive neoadjuvant chemo-immunotherapy. 4. Be physically able to walk. 5. Be able to complete forms, understand instructions and read in English. 6. Agree to be randomly assigned to either group. 7. Have clearance from oncologist to participate. 8. Not exercising (less than 150 min/week). 9. Not consuming more than 7 fruits and vegetable/day. Exclusion Criteria: 1. Having already started a 2nd chemotherapy cycle. 2. Pregnancy or intention to become pregnant. 3. Presence of dementia or major psychiatric disease. 4. Recent (past year) stroke, myocardial infarction, or congestive heart failure.

Study sites (1)

CT