20 Participants NeededMy employer runs this trial

Resistant Potato Starch for Breast Cancer

(AIMSS-RPS Trial)

CA
Overseen ByCancer AnswerLine
Age: Any Age
Sex: Any
Trial Phase: Phase 2
Sponsor: University of Michigan Rogel Cancer Center
Must be taking: Aromatase inhibitors
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a dietary supplement called resistant potato starch can reduce joint pain and stiffness in individuals with stage 0-III breast cancer or those at high risk who are starting aromatase inhibitor therapy. Aromatase inhibitors treat or prevent breast cancer but may cause uncomfortable bone and muscle symptoms. Resistant potato starch might enhance beneficial gut bacteria, potentially easing these symptoms. Individuals planning to start aromatase inhibitor therapy for breast cancer or due to high risk, and who experience joint pain, may be suitable for this study. Participants will take the supplement daily for 24 weeks. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering a chance to potentially benefit from innovative therapy.

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

The trial does not specify if you need to stop taking your current medications, but it allows certain therapies like gonadotropin-releasing hormone antagonist, anti-osteoclast therapy, anti-HER2 therapy, ribociclib, and PARP inhibitors. However, you cannot use abemaciclib, chemotherapy, immunotherapy, or prebiotics during the study.

Is there any evidence suggesting that resistant potato starch is likely to be safe for humans?

Research shows that resistant potato starch is usually well-tolerated. Studies have found that it supports gut health by encouraging the growth of beneficial bacteria. A healthy gut may help reduce symptoms like joint pain or stiffness, which some people experience when taking aromatase inhibitors for breast cancer.

Although detailed safety information for using resistant potato starch in this way isn't widely available, it is a dietary supplement used in various studies without major safety concerns. Researchers have tested it in both healthy individuals and those with different medical conditions, and it is generally considered safe to consume. However, as with any treatment, individual reactions may vary. Always consult a healthcare provider before starting any new supplement, especially during cancer treatment.12345

Why do researchers think this study treatment might be promising for breast cancer?

Resistant Potato Starch (RPS) is unique because it offers a dietary approach to support breast cancer care, unlike traditional treatments that typically include surgery, chemotherapy, radiation, and hormone therapy. Researchers are excited about RPS because it serves as a form of supportive care that may enhance the body's natural defenses against cancer by altering gut microbiota and improving metabolic health. This approach, taken orally once a day, is non-invasive and emphasizes wellness and nutritional support, potentially offering a complementary benefit to existing treatments without adding significant toxicity.

What evidence suggests that resistant potato starch might be an effective treatment for musculoskeletal symptoms in breast cancer patients?

Research has shown that resistant potato starch might help reduce joint pain and stiffness in breast cancer patients taking aromatase inhibitors, which often cause these symptoms. In this trial, participants will receive resistant potato starch as part of their supportive care. Studies suggest that this type of starch supports healthy gut bacteria, potentially easing these symptoms. Foods like boiled potatoes, which contain resistant starch, have been linked to lower breast cancer risks. Early research in healthy individuals also indicates that resistant potato starch can improve gut health. These findings suggest that resistant potato starch might effectively manage symptoms related to aromatase inhibitor treatment.12346

Who Is on the Research Team?

NL

Norah L Henry, M.D.

Principal Investigator

University of Michigan Rogel Cancer Center

Are You a Good Fit for This Trial?

This trial is for people with stage 0-III breast cancer or those at high risk of breast cancer who are about to start aromatase inhibitor therapy for at least 24 weeks. Participants must be able to take oral medication, read English, and have mild to moderate joint pain.

Inclusion Criteria

I am planning to start AI therapy for at least 24 weeks for breast cancer or high risk.
* Able to read and understand English
* Aware of the nature of her diagnosis, understands study requirement, and able to sign an informed consent form
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive resistant potato starch (RPS) daily for 24 weeks while undergoing aromatase inhibitor therapy

24 weeks
Regular visits for monitoring and assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Resistant Potato Starch

Trial Overview

The study is testing whether a dietary supplement called resistant potato starch can safely reduce bone and muscle symptoms in people starting aromatase inhibitor treatment for breast cancer. It compares the effects of this supplement on musculoskeletal discomfort.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Supportive Care (RPS)Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Michigan Rogel Cancer Center

Lead Sponsor

Trials
303
Recruited
20,700+

Breast Cancer Research Foundation

Collaborator

Trials
79
Recruited
40,500+

Citations

A Dietary Supplement (Resistant Potato Starch) for ...

Taking resistant potato starch while receiving aromatase inhibitor therapy may reduce musculoskeletal symptoms in patients with stage 0-III ...

Resistant Potato Starch for Breast Cancer (AIMSS-RPS Trial)

Taking resistant potato starch while receiving aromatase inhibitor therapy may reduce musculoskeletal symptoms in patients with stage 0-III ...

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/26028070/

Dietary resistant starch contained foods and breast cancer ...

Our results show that certain RS containing foods, in particular whole wheat bread, legumes and boiled potato may reduce BC risk.

Dietary Resistant Starch Contained Foods and Breast Cancer ...

The results of a study in rats with consumption of combined diet containing potato resistant starch or fiber and protein showed lower bacteroides and higher ...

Can Dietary-Resistant Starch Mitigate GVHD? Ongoing ...

In addition, a study led by Thomas Schmidt, PhD, showed that healthy people who received a prebiotic in the form of resistant potato starch had ...

Pilot study of intestinal microbiome alteration with resistant ...

Pilot study of intestinal microbiome alteration with resistant potato starch (RPS) in patients (pts) treated with dual immune checkpoint ...