Potato Resistant Starch + Iron Chelation for Stem Cell Transplant

Overseen By Mary Riwes

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Michigan Rogel Cancer Center

Must not be taking: Deferasirox

Disqualifiers: Inflammatory bowel disease, Gastric bypass, Clostridium difficile, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 15 weeks

50 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are receiving treatment for iron overload with deferasirox, you may not be eligible to participate.

What data supports the effectiveness of the treatment Potato Resistant Starch + Iron Chelation for Stem Cell Transplant?

Research shows that iron chelation therapy can help reduce iron toxicity, which is harmful to patients undergoing stem cell transplants, by limiting oxidative stress and improving transplant outcomes. Additionally, iron chelation has been associated with reduced risk of complications and improved survival in transplant patients with iron overload. ^{1 2 3 4 5}

Is the combination of potato resistant starch and iron chelation safe for humans?

There is limited safety data on the combination of potato resistant starch and iron chelation in humans, but studies on potato resistant starch alone suggest it is generally safe and may improve gut health by increasing beneficial short-chain fatty acids and supporting healthy gut bacteria. ^{6 7 8 9 10}

How does the treatment Potato Resistant Starch differ from other treatments for stem cell transplant?

Potato Resistant Starch is unique because it focuses on improving gut health by increasing beneficial short-chain fatty acids like butyrate, which can enhance the intestinal microbiome and potentially improve outcomes after stem cell transplantation. This approach is different from traditional treatments that may not target gut health directly. ^{6 8 10 11 12}

What is the purpose of this trial?

The study will evaluate the safety and early efficacy of administering the combination of a commercially available potato-based resistant starch along with iron chelation therapy to subjects undergoing alloHCT.

Research Team

Mary Riwes

Principal Investigator

University of Michigan Rogel Cancer Center

Eligibility Criteria

This trial is for adults over 18 with blood disorders who are getting a stem cell transplant from a fully matched donor after intense treatment. They must be able to swallow pills, have good physical function, and understand the study. People can't join if they have certain gut diseases, allergies to iron medicine (deferasirox), are in another GVHD prevention trial, had gastric bypass surgery, active C. difficile infection or need treatment for iron deficiency anemia.

Inclusion Criteria

I am getting a stem cell transplant from a matched donor after intense treatment.

Ability to understand and the willingness to sign a written informed consent

I have a donor who matches me completely and can donate cells.

Exclusion Criteria

Any physical or psychological condition that, in the opinion of the investigator, would pose an unacceptable risk to the patient or raise concern that the patient would not comply with protocol procedures

I am being treated for active inflammatory bowel disease.

Known hypersensitivity to deferasirox or any component of Jadenu or Exjade

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-treatment

Deferasirox intervention begins one week prior to the RPS conditioning phase

1 week

Treatment

Participants receive Resistant Potato Starch and Iron Chelation therapy through day +100 post-transplant

15 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of GVHD-free and relapse-free survival

up to 1 year post-transplantation

Treatment Details

Interventions

• Iron chelation
• Potato Resistant Starch

Trial Overview The study tests if taking a potato-based resistant starch plus iron chelation therapy with deferasirox helps patients undergoing allogeneic stem cell transplantation (alloHCT). It aims to see how safe this combination is and whether it could improve early outcomes post-transplant.

Participant Groups

Group I: Study Treatment Experimental Treatment 2 Interventions

All subjects will be enrolled into one arm and will be treated with RPS and Iron Chelation

Who Is Running the Clinical Trial?

University of Michigan Rogel Cancer Center

Lead Sponsor

Trials

303

Recruited

20,700+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Findings from Research

Rats fed diets containing various colored potato flakes (white, red, and purple) showed significant improvements in cecal health, including lower cecal pH and higher concentrations of short-chain fatty acids (SCFAs) compared to those on a control diet, indicating enhanced fermentation and beneficial gut bacteria activity.

The study found that the consumption of purple potato flakes led to increased fecal excretion of total and secondary bile acids, suggesting that these potato flakes may positively influence bile acid metabolism and overall colonic health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feeding potato flakes affects cecal short-chain fatty acids, microflora and fecal bile acids in rats. Han, KH., Hayashi, N., Hashimoto, N., et al.[2018]

In a study involving rats, potato starch from Snowden and Kitahime varieties improved cecal fermentation by increasing beneficial short-chain fatty acids and lowering cecal pH compared to a control group.

The consumption of potato starch also enhanced immune function by raising cecal immunoglobulin A levels and reducing harmful compounds like ammonia-nitrogen and indole, suggesting potential health benefits for gut health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Raw Potato Starch with High Resistant Starch Levels on Cecal Fermentation Properties in Rats. Nagata, R., Innami, N., Pelpolage, S., et al.[2020]

A feasibility study involving 10 adults showed that daily intake of resistant potato starch (RPS) from day -7 to day 100 after allogeneic hematopoietic stem cell transplantation significantly increased fecal butyrate levels, indicating a positive impact on gut health (P < 0.0001).

The study also found that RPS led to more stable plasma metabolites in participants compared to historical controls, suggesting potential benefits for metabolic health post-transplant, and a phase 2 trial is planned to further investigate its effects on graft-versus-host disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of a dietary intervention to modify gut microbial metabolism in patients with hematopoietic stem cell transplantation. Riwes, MM., Golob, JL., Magenau, J., et al.[2023]

Rats fed raw potato powder (RP) showed significantly higher levels of resistant starch and beneficial lactic acid bacteria compared to those on a control diet, indicating that RP may enhance gut health.

The RP group also had lower cecal pH and higher concentrations of short-chain fatty acids (SCFAs), suggesting that raw potato powder can positively influence intestinal fermentation and microbial activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Potato powders prepared by successive cooking-process depending on resistant starch content affect the intestinal fermentation in rats. Kawakami, S., Han, KH., Araki, T., et al.[2018]

In a study involving 32 Wistar rats, the addition of resistant starch RS4 to high-fat diets significantly reduced total cholesterol levels by about 25% and triglycerides by approximately 47% in those fed with soybean oil, indicating its beneficial effects on lipid metabolism.

Rats consuming diets with RS4 also showed lower liver damage, as indicated by hepatic enzyme activity, and higher levels of HDL-cholesterol compared to control groups, suggesting improved overall metabolic health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of resistant starch RS4 added to the high-fat diets on selected biochemical parameters in Wistar rats. Bronkowska, M., Orzeł, D., Łoźna, K., et al.[2013]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Addition of iron to erythropoiesis-stimulating agents in cancer patients: a meta-analysis of randomized trials. [2021]

2. England pubmed.ncbi.nlm.nih.gov

The transplant iron score as a predictor of stem cell transplant survival. [2021]

3. England pubmed.ncbi.nlm.nih.gov

The oral iron chelator deferasirox might improve survival in allogeneic hematopoietic cell transplant (alloHSCT) recipients with transfusional iron overload. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Iron Toxicity and Chelation Therapy in Hematopoietic Stem Cell Transplant. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Iron chelation treatment with deferasirox prior to high-dose chemotherapy and autologous stem cell transplantation may reduce the risk of hepatic veno-occlusive disease in children with high-risk solid tumors. [2018]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Feeding potato flakes affects cecal short-chain fatty acids, microflora and fecal bile acids in rats. [2018]

7. Japan pubmed.ncbi.nlm.nih.gov

Effects of Raw Potato Starch with High Resistant Starch Levels on Cecal Fermentation Properties in Rats. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Feasibility of a dietary intervention to modify gut microbial metabolism in patients with hematopoietic stem cell transplantation. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Potato powders prepared by successive cooking-process depending on resistant starch content affect the intestinal fermentation in rats. [2018]

10. United States pubmed.ncbi.nlm.nih.gov

Class 2 resistant starches lower plasma and liver lipids and improve mineral retention in rats. [2022]

11. Poland pubmed.ncbi.nlm.nih.gov

Effect of resistant starch RS4 added to the high-fat diets on selected biochemical parameters in Wistar rats. [2013]

12. Poland pubmed.ncbi.nlm.nih.gov

[Effects of resistant starch RS4 on magnesium and iron absorption in Wistar rats]. [2013]