Probiotics for Ovarian Cancer

Overseen By The Ohio State University Comprehensive Cancer Center

Age: 18+

Sex: Female

Trial Phase: Phase < 1

Sponsor: Ohio State University Comprehensive Cancer Center

Must be taking: Platinum chemotherapy

Must not be taking: Probiotics, Prebiotics

Disqualifiers: Borderline tumors, Chronic inflammation, others

Compensation: Varies

Number of Visits: 6

Duration: 18 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how probiotics (live bacteria that may boost gut health) affect the gut and vaginal microbiome of ovarian cancer patients undergoing chemotherapy. The goal is to determine if these probiotics can improve quality of life, symptoms, and overall treatment outcomes for patients with advanced or recurrent ovarian cancer. Participants will receive either a probiotic or a placebo alongside their chemotherapy over several cycles. Ideal candidates have advanced or recurrent ovarian cancer, are starting platinum-based chemotherapy, and are willing to adhere to the study's guidelines. As an Early Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants a chance to contribute to groundbreaking research.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must not take any other probiotic or prebiotic supplements during the study.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research shows that probiotics are generally safe and can benefit people with gynecologic cancers. Studies have found that probiotics can ease stomach issues caused by cancer treatments like radiation, suggesting that patients tolerate them well. In another study, probiotics helped with blood-related problems in ovarian cancer patients, further supporting their safety.

Although this clinical trial is in its early stages, focusing mainly on safety, existing research is encouraging. Probiotics are already widely used as dietary supplements to support gut health, adding confidence in their safety for this trial. However, as with any treatment, it is important to monitor for side effects and consult a healthcare provider before joining the trial. ^{1 2 3 4 5}

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

Researchers are excited about using probiotics for ovarian cancer because they offer a novel approach by potentially enhancing the body's natural defenses against cancer. Unlike traditional chemotherapy, which targets cancer cells directly, probiotics aim to improve gut health, which could support the immune system and reduce inflammation. This approach is unique as it uses beneficial bacteria to potentially boost the body's response to cancer treatment, offering a complementary strategy to standard chemotherapy.

What evidence suggests that this probiotic intervention might be an effective treatment for ovarian cancer?

This trial will compare the effects of probiotics with a placebo in patients undergoing standard-of-care platinum chemotherapy for ovarian cancer. Research has suggested that probiotics might help fight ovarian cancer by strengthening the immune system, reducing swelling, and potentially slowing cancer cell growth. Some studies have shown that probiotics can lessen side effects from cancer treatments, such as stomach problems caused by radiation, and help manage blood issues in ovarian cancer patients, like unusual platelet levels. Overall, probiotics are believed to support the body during cancer treatment by improving gut health and possibly enhancing treatment outcomes. ^{2 3 6 7 8}

Who Is on the Research Team?

Laura Chambers, DO

Principal Investigator

Ohio State University Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for patients with advanced or recurrent ovarian cancer who are undergoing platinum chemotherapy. It's designed to see if probiotics can help maintain a healthy gut and vaginal microbiome during treatment.

Inclusion Criteria

Agreeable to participate in all research activities defined in the study

Agreeable to not make significant changes to their diet throughout the course of the study

I am older than 18 years.

Exclusion Criteria

I have a chronic digestive condition or a current serious problem with my digestive tract.

Prior allergy or food intolerance to any probiotic product

Known hypersensitivity to any component of study product (Akkermansia muciniphila, Anaerobutyricum hallii, Clostridium beijerinckii, Clostridium butyricum and Bifidobacterium infantis, chicory inulin, magnesium stearate, grape food color, and silica)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a probiotic or placebo orally twice daily during platinum chemotherapy cycles

18 weeks

6 visits (in-person) for each chemotherapy cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Sample Collection

Blood and vaginal samples are collected throughout the study

During treatment phase

What Are the Treatments Tested in This Trial?

Interventions

• Probiotic

Trial Overview The study tests the impact of a probiotic supplement on the gut and vaginal health of ovarian cancer patients receiving chemotherapy. Participants will either receive the probiotic or a placebo, alongside regular biospecimen collection and questionnaires.

How Is the Trial Designed?

Group I: Arm I (probiotic) Experimental Treatment 3 Interventions

Patients receive probiotic PO BID beginning within seven days of SOC platinum chemotherapy cycle 1 until seven days after their cycle 6. Cycles repeat every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo blood and vaginal sample collection throughout the study.

Group II: Arm II (placebo) Placebo Group 3 Interventions

Patients receive placebo PO BID beginning within seven days of SOC platinum chemotherapy cycle 1 until seven days after their cycle 6. Cycles repeat every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo blood and vaginal sample collection throughout the study.

Who Is Running the Clinical Trial?

Ohio State University Comprehensive Cancer Center

Lead Sponsor

Trials

350

Recruited

295,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12108976/

Insights from Female Tumor Cell Culture Studies - PMC It highlights that probiotics can enhance the body's immune response, reduce inflammation, and inhibit the growth of cancer cells by inducing ...

2. ajog.org ajog.org/article/S0002-9378(25)00715-X/abstract

Assessment of probiotic and prebiotic use in gynecologic ... Probiotic supplementation demonstrates consistent benefit in reducing radiation-induced gastrointestinal toxicity in gynecologic cancer patients ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1756464624003189

Probiotics alleviate paraneoplastic thrombocythemia of ... Oral probiotics effectively mitigated platelet count surges and improved coagulation functions in ovarian cancer patients with paraneoplastic thrombocytosis.

4. gynecologiconcology-online.net gynecologiconcology-online.net/article/S0090-8258(25)00333-6/fulltext

PRO-PLATINUM: A randomized, double-blind, placebo- ... This study investigates whether modifying the microbiome through probiotic supplementation can enhance treatment efficacy, improve quality of life and mitigate ...

5. molmed.biomedcentral.com molmed.biomedcentral.com/articles/10.1186/s10020-021-00295-2

The role of the microbiome in ovarian cancer We discuss the applicability of nutrients, antibiotics, and probiotics to harness the microbiome and support ovarian cancer therapy.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/41072704/

Assessment of Probiotic and Prebiotic Use in Gynecologic ... Probiotic supplementation demonstrates consistent benefit in reducing radiation-induced gastrointestinal toxicity in gynecologic cancer ...

7. mdpi.com mdpi.com/2218-273X/15/5/657

Probiotics as Anti-Tumor Agents: Insights from Female ... These findings suggest that certain probiotic combinations can arrest the cell cycle, promote cell death, and reduce cell migration.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT07144826

Effects of a Probiotic Intervention on the Gut and Vaginal ... A probiotic intervention during platinum chemotherapy in ovarian cancer patients may impact the gut and vaginal microbiota, quality of life, symptoms, and ...