Chia Seeds for Breast Cancer

(GEMMA Trial)

CT
RN
Overseen ByRita Nanda
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Chicago
Must be taking: Endocrine therapy
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how chia seeds can benefit individuals with a specific type of breast cancer (HR+/HER2-) who receive abemaciclib with endocrine therapy. The researchers aim to determine if chia seeds, known for their high fiber content, can improve gut health and reduce treatment-related gut issues. Participants will either consume chia seeds before starting their cancer treatment or have their gut health monitored throughout their treatment. This trial may suit individuals with HR+/HER2- breast cancer who are willing to provide stool samples and are about to begin abemaciclib therapy. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance cancer treatment experiences.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, since the study involves standard care therapy with abemaciclib and endocrine therapy, you may need to continue these treatments if you are already on them.

What prior data suggests that chia seeds are safe for breast cancer patients?

Research has shown that chia seeds are generally safe for individuals with estrogen-positive breast cancer. Some studies suggest that chia seeds, rich in omega-3 fatty acids, can be part of a diet to help manage breast cancer. These omega-3s also occur in foods like olive oil and walnuts.

No specific evidence indicates that chia seeds cause harm when used as a supplement for breast cancer. In fact, chia seeds are often recommended as a healthy addition to support overall well-being in people with certain types of breast cancer.

While high amounts of chia seed oil might affect breast cancer cells in a lab, no strong evidence suggests that consuming chia seeds in normal amounts poses a risk. Overall, chia seeds appear well-tolerated and can be a safe choice for individuals seeking to support their health during breast cancer treatment.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the potential of chia seeds to modulate the gut microbiome in patients with breast cancer, a unique approach compared to traditional treatments like hormone therapies and chemotherapy. Unlike these standard options, which directly target cancer cells, the chia seed intervention aims to enhance gut health by increasing fiber intake, promoting a diverse microbiome, and reducing inflammation and dysbiosis. By doing so, it might not only support cancer treatment but also improve overall health and potentially minimize side effects associated with conventional therapies. This trial also seeks to understand how gut microbiome changes during treatment with abemaciclib can influence the development and severity of diarrhea, a common side effect, which could lead to better management strategies in the future.

What evidence suggests that chia seeds might be an effective treatment for breast cancer?

This trial will evaluate the effects of chia seeds on breast cancer. Research suggests that chia seeds might help fight breast cancer. Some studies have found that chia seeds contain substances that can slow the growth of breast cancer cells by affecting certain molecules related to estrogen, a hormone that can sometimes promote cancer growth. Chia seeds are also rich in omega-3 fatty acids, known to help reduce inflammation. Since inflammation often links to cancer growth, these seeds might help lower that risk. Additionally, chia seeds are safe for people with estrogen-positive breast cancer, the type of cancer being studied here. While more research is needed to confirm these effects in humans, these early findings are promising. Participants in the Dietary Intervention Cohort of this trial will receive a 2-week chia seed intervention to assess its impact on the gut microbiome before starting abemaciclib.12346

Who Is on the Research Team?

RN

Rita Nanda

Principal Investigator

University of Chicago

Are You a Good Fit for This Trial?

This trial is for adults (18+) with HR+/HER2- breast cancer who are about to start abemaciclib plus hormone therapy. Participants must be able to give consent, provide stool samples, and have good physical function. Both men and women can join.

Inclusion Criteria

I am fully active or can care for myself with little or no help.
* Be willing and able to provide written informed consent for the trial
My tumor tested HER2 negative before treatment.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Observational Study

Participants' baseline gut microbiome composition is characterized before and during abemaciclib treatment, with continuous stool sample collection and clinical toxicity assessments.

2 years

Dietary Intervention

A 2-week chia seed intervention is administered to modulate the gut microbiome before the initiation of abemaciclib.

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, focusing on microbiome dynamics and diarrhea incidence.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Chia Seeds

Trial Overview

The study first observes gut health in patients on standard treatment, then tests if adding chia seeds (a fiber supplement) affects gut bacteria or digestive side effects. It involves stool sample collection and a small pilot of chia seed supplementation.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Observational CohortExperimental Treatment1 Intervention
Group II: Dietary Intervention CohortExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials
1,086
Recruited
844,000+

Citations

Chia Seeds for Breast Cancer (GEMMA Trial)

... Chia Seeds will have tolerable side effects & efficacy for patients with Breast Cancer and Breast Cancer. Learn more about the study.

(PDF) Effect of Chia Seed Oil (Salvia hispanica L.) on Cell ...

Chia seed oil in high concentrations could potentially increase the viability of breast cancer cells.

The suppressive role of nanoencapsulated chia oil against ...

The findings showed that Chia nanocapsules could reduce the risk of breast cancer in rats. Several studies have confirmed Chia's anticancer properties. Mutar ...

Effect of Chia Seed Oil (Salvia hispanica L.) on Cell ...

This study suggests that chia seed oil in high concentrations could potentially increase the viability of breast cancer cells. However, at low ...

HER2-Positive Breast Cancer Diet

... effectiveness of treatment for HER2-positive breast cancer. Foods high in omega-3 fatty acids include: olive oil; flaxseed; chia seeds; pumpkin seeds; pine nuts ...

taking Chia seeds after having estrogen positive breast ...

Here's some information from Memorial Sloan Kettering Cancer Center about chia seeds, however not specifically related to estrogen positive cancer.