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New treatment option for Anatomic Stage 0 Breast Cancer AJCC v8
Official title A Dietary Supplement (Resistant Potato Starch) for Reducing Musculoskeletal Symptoms in Individuals Planning to Receive Aromatase Inhibitor Therapy, AIMSS-RPS Trial
ClinicalTrials.gov ID: NCT07443943
What this study is testing
What is Starch, Potato?
Starch, Potato is an investigational medicine, being studied as a potential treatment for anatomic stage 0 breast cancer ajcc v8.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This phase II trial tests the safety and effectiveness of a dietary supplement called resistant potato starch for reducing musculoskeletal symptoms in patients with stage 0-III breast cancer or who are at high risk for breast cancer and are planning to receive treatment with an aromatase inhibitor. Aromatase inhibitors are a type of drug commonly used for the treatment or prevention of breast cancer.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults. Healthy volunteers may be eligible.
You may be able to join if
- Patient who is planning to start standard-of-care AI therapy and receive treatment for at least 24 weeks. Can be planning to take AI therapy for...
- Average joint pain 0-6 on a 0-10 scale during the 7 days prior to study enrollment
- Able to take oral medication
- Able to read and understand English
- Aware of the nature of her diagnosis, understands study requirement, and able to sign an informed consent form
You likely can't join if
- Distant metastatic breast cancer
- Current or planned use of abemaciclib during study participation
- Current or planned use of chemotherapy or immunotherapy during study participation
- Pregnant or breast feeding, or planning to become pregnant during study participation
- Known active inflammatory bowel disease
- History of colectomy and/or gastric bypass
See the full eligibility criteria
- Patient who is planning to start standard-of-care AI therapy and receive treatment for at least 24 weeks. Can be planning to take AI therapy for stage 0-3 breast cancer or because they are at high risk of developing...
- Average joint pain 0-6 on a 0-10 scale during the 7 days prior to study enrollment
- Able to take oral medication
- Able to read and understand English
- Aware of the nature of her diagnosis, understands study requirement, and able to sign an informed consent form
- Distant metastatic breast cancer
- Current or planned use of abemaciclib during study participation
- Current or planned use of chemotherapy or immunotherapy during study participation
- Pregnant or breast feeding, or planning to become pregnant during study participation
- Known active inflammatory bowel disease
- History of colectomy and/or gastric bypass
- Prior AI therapy except in the context of fertility treatment
- Planned use of prebiotics during study participation
- Use of estrogen supplementation other than vaginal estrogen
- Receipt of another investigational agent concurrent with participation in this trial
The study team makes the final eligibility decision.
Where it's taking place
- Ann Arbor, Michigan, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, not specified. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ann Arbor, Michigan, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.