Improving heart health through nutrition for childhood cancer survivors

Proof-of-Concept Testing of the Cardiovascular Health Equity Through Food (CHEF) Intervention in Childhood Cancer Survivors

This study is testing a nutrition program to see if it can help childhood cancer survivors improve their heart health.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 17 (estimated)
• Ages: N/A to 18 Years
• Sex: All
• Sponsor: Dana-Farber Cancer Institute (Academic / other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 2 sites (Boston, Massachusetts and 1 other locations)
• Trial ID: NCT06609473 on ClinicalTrials.gov

What this trial studies

The Cardiovascular Health Equity Through Food (CHEF) program aims to support healthy eating habits among childhood cancer survivors to promote long-term cardiovascular health. This proof-of-concept study will assess the impact of the CHEF intervention on cardiovascular outcomes by collecting data through surveys, interviews, and medical records. Participants will be screened for eligibility and will engage in questionnaires and interviews over a six-month period. The study seeks to identify effective strategies for implementing the intervention in this vulnerable population.

Who should consider this trial

Good fit: Ideal candidates include children who have undergone cancer treatment and have one or more cardiovascular risk factors.

Not a fit: Patients who are not childhood cancer survivors or do not have cardiovascular risk factors may not benefit from this study.

Why it matters

Potential benefit: If successful, this program could significantly improve cardiovascular health outcomes for childhood cancer survivors.

How similar studies have performed: While similar interventions targeting nutrition and health in cancer survivors have shown promise, this specific approach is relatively novel.

Eligibility criteria

Inclusion Criteria:

* Child with any primary cancer diagnosis (non-relapsed, non-secondary malignancy) who has received cancer-directed therapy that includes chemotherapy and/or radiation therapy;
* Child is within one of the following time windows:

  1. Among those receiving chemotherapy, any time from start of last planned cycle of chemotherapy until 12 months from completion of chemotherapy;
  2. Among those receiving radiation therapy alone or radiation and surgery, any time from completion of radiation until 12 months post completion;
* Child has 1 or more cardiovascular risk factor (defined as any of: body mass index ≥ 85th percentile; systolic or diastolic blood pressure ≥90th percentile; dyslipidemia \[triglycerides ≥150 mg/dL, total cholesterol ≥200 mg/dL, LDL cholesterol ≥130 mg/dL, HDL cholesterol ≤40 mg/dL\]; impaired glucose metabolism \[fasting glucose ≥100 mg/dL, hemoglobin A1c ≥5.7%\]; anthracycline exposure ≥100 mg/m2; or any radiation exposure to chest, brain, thoracic spine, or total body);
* Child is ≤18 years of age at time of enrollment, or over 18 years of age but under medical guardianship;
* Parent/guardian screened positive for food insecurity.\* \*Assessed through validated 2-item food insecurity screen.

Exclusion Criteria:

* Patient received only surgery, or watchful waiting/surveillance, for cancer- directed therapy;
* Foreign national family receiving cancer care as an embassy-pay patient.

Where this trial is running

Boston, Massachusetts and 1 other locations

• Boston Children's Hospital — Boston, Massachusetts, United States (Recruiting)
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States (Recruiting)

Study contacts

• Principal investigator: Rahela Aziz-Bose, MD — Dana-Farber Cancer Institute
• Study coordinator: Rahela Aziz-Bose, MD

Conditions Childhood Cancer; Childhood Cancer Survivors; Cardiovascular Health; Childhood Cancer Survivorship