960 Participants Needed

Dietary Inflammatory Potential for Breast Cancer Risk

TO
Overseen ByThe Ohio State University Comprehensive Cancer Center
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Ohio State University Comprehensive Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how diet might influence the risk of developing breast cancer. Researchers aim to determine if certain foods could increase or decrease this risk, potentially aiding in the development of improved prevention strategies. Participants will undergo regular check-ups and complete questionnaires over several years to collect this data. The trial includes a dietary intervention, also known as nutritional counseling or dietary therapy, and suits individuals at high risk for breast cancer due to family history or specific medical conditions like atypical breast changes.

As an unphased trial, it provides participants the chance to contribute to groundbreaking research that could lead to new prevention strategies.

Do I have to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this dietary intervention is safe?

Research shows that dietary changes can affect breast cancer risk and enhance quality of life. Studies have found that certain eating habits might reduce the chance of cancer recurrence and support overall health. Evidence also suggests that these diets can aid during cancer treatment, leading to better outcomes. Although the exact safety of these dietary changes in humans isn't fully detailed, they are usually well-tolerated. These changes focus on using food to improve health, which is generally safe for most people.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the impact of dietary changes on breast cancer risk. Unlike traditional treatments such as surgery, chemotherapy, or radiation, this approach focuses on dietary intervention as a preventive measure, potentially reducing inflammation that may contribute to cancer development. This trial aims to uncover how certain foods might influence cancer risk, providing a non-invasive, lifestyle-based strategy that could complement existing treatments and improve overall health. The potential to empower individuals to actively participate in their health management through diet is a compelling aspect of this research.

What evidence suggests that this dietary intervention is effective for reducing breast cancer risk?

Studies have shown that diet can significantly affect the risk of breast cancer and its recurrence. For instance, research indicates that reducing fat intake might lower the chances of breast cancer returning. One study suggested that dietary changes could improve the quality of life for those at risk of or dealing with breast cancer. Additionally, long-term dietary changes have been linked to a small decrease in breast cancer cases and deaths, though this was not statistically significant. Overall, these findings support the idea that diet could impact breast cancer risk. Participants in this trial will undergo physical exams and complete questionnaires to assess the impact of dietary habits on breast cancer risk.16789

Who Is on the Research Team?

SD

Sagar D Sardesai, MSPH, PhD

Principal Investigator

Ohio State University Comprehensive Cancer Center

Are You a Good Fit for This Trial?

Inclusion Criteria

Must consent to continued follow-up of medical records during the study period
Established in the high risk clinic at OSUCCC- James (includes patients with family history of breast cancer [BC], known genetic predisposition, personal history of known atypia/breast lobular carcinoma in situ [LCIS], or prior chest wall radiation)
Patients at high risk for BC established in the surgical oncology clinic at Stefanie Spielman Comprehensive Breast Center (SSCBC), with one of the following diagnoses: Atypical ductal hyperplasia (ADH), atypical lobular hyperplasia (ALH), lobular carcinoma in situ (LCIS), sclerosing adenosis (SA), or radial scars (RS)
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete baseline physical measurements and dietary assessments using the Diet History Questionnaire III

1 visit
1 visit (in-person)

Longitudinal Monitoring

Participants complete physical measurements every 6 months and questionnaires annually for 5 years

5 years
10 visits (in-person), 5 visits (virtual)

Extended Follow-up

Participants are followed up annually in years 5-10 to monitor long-term outcomes

5 years
5 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Dietary Intervention

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Observational (physical exam, questionnaire)Experimental Treatment3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ohio State University Comprehensive Cancer Center

Lead Sponsor

Trials
350
Recruited
295,000+

Citations

Dietary Interventions for Breast Cancer Prevention

Their study highlighted that dietary patterns significantly impacted both the risk of BC recurrence and the overall quality of life.

Dietary fat reduction and breast cancer outcome

The study determined that low-fat dietary interventions can influence body weight and decrease breast cancer recurrence.

Dietary interventions in cancer: a systematic review of all ...

In this systematic review, we assessed all randomized controlled trials (RCTs) investigating dietary interventions for cancer patients.

Dietary Modification and Breast Cancer Mortality: Long-Term ...

During 8.5 years of dietary intervention, breast cancer incidence and deaths as a result of breast cancer were nonsignificantly lower in the intervention group, ...

What are the most effective exercise, physical activity and ...

This systematic review and network meta-analysis aimed to identify the most effective exercise, physical activity, and dietary interventions to reduce fat mass ...

A Low-Insulinemic Dietary Intervention to Reduce Breast ...

We will determine if a low-insulinemic dietary pattern intervention is feasible and effective in reducing breast cancer risk in high-risk women. Detailed ...

Effects of dietary intervention on human diseases

These results suggest that dietary interventions may be promising for improving cancer treatment outcomes. Accumulating data suggest that ...

Nutrition and Breast Cancer: A Literature Review on ...

The results of this prospective study indicate that a high-saturated-fat diet increases risk of BC and, most conspicuously, of receptor-positive cancer, ...

Dietary interventions and tumor response to chemotherapy ...

This review highlights the areas for further research to increase opportunities for nutritional-based interventions as adjuvant to chemotherapy for breast ...