PRehabilitation Intervention to Modify Eating for Breast Cancer Patients (PRIME)

ConditionBreast Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorH. Lee Moffitt Cancer Center and Research Institute

About this trial

This single-arm pilot study evaluates the feasibility and acceptability of a 4-week Mediterranean diet-based feeding intervention as nutritional prehabilitation for newly diagnosed, treatment-naïve breast cancer patients prior to surgery. All meals are provided to participants. Secondary aims include assessing changes in body composition, metabolic biomarkers, inflammation, gut microbiome composition, patient-reported outcomes, and clinician-reported surgical recovery metrics.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Newly diagnosed stage I-III breast cancer.

Treatment-naïve; no neoadjuvant therapy planned.

Surgery scheduled at Moffitt in 1-2 months.

Post-menopausal.

Disqualifiers

Stage IV/metastatic disease.

Prior cancer.

Surgery scheduled sooner than 4-5 weeks.

NCI FVS ≥5 servings/day.

Trial design

Design model

Single group

Treatments tested in this trial

  • Mediterranean Diet

    Other intervention

    A two-week cyclic menu (14 unique days of meals repeated) approach will be used for the Mediterranean diet intervention. Participants will be provided with 3 meals a day and receive daily snacks to consume.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Mediterranean DietExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Feasibility of Enrollment

Percentage of eligible participants who enroll.

Time frame
Up to 1 year
2

Retention

Percentage of enrolled participants will complete assessments at both timepoints

Time frame
8 weeks post-surgery
3

Adherence

Percentage of participants who consume ≥70% of study meals.

Time frame
At 4 weeks.
4

Acceptability

Percentage of participants who rate overall satisfaction as "agree" and "strongly agree."

Time frame
8 weeks post-surgery

Secondary outcomes

Other outcomes

Sponsors and contacts

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