Resistant Potato Starch for Breast Cancer
(AIMSS-RPS 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.12345Why 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?
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive resistant potato starch (RPS) daily for 24 weeks while undergoing aromatase inhibitor therapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
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
Participants receive RPS PO QD for 24 weeks in the absence of unacceptable toxicity.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Michigan Rogel Cancer Center
Lead Sponsor
Breast Cancer Research Foundation
Collaborator
Citations
1.
clinicaltrials.gov
clinicaltrials.gov/study/NCT07443943?term=CANCER%20NOT%20myeloma%20NOT%20leukemia&aggFilters=phase:,ages:,funderType:&tab=study&a=1A 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 ...
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 ...
5.
cancernursingtoday.com
cancernursingtoday.com/post/can-dietary-resistant-starch-mitigate-gvhd-ongoing-phase-ii-study-evaluates-questionCan 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 ...
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