Oral Fiber Supplementation for Blood Cancers

Overseen By David Fredricks

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Fred Hutchinson Cancer Research Center

Disqualifiers: Major psychiatric diagnosis, Pregnancy, others

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

Compensation: Varies

Number of Visits: 3

Duration: Until hospital discharge

30 Participants Needed

Trial Summary

What is the purpose of this trial?

This clinical trial examines sustained oral fiber supplementation for patients undergoing donor stem cell transplantation for hematological malignancies. Patients undergoing donor stem cell transplantation often develop oral and gastrointestinal damage from chemotherapy, radiotherapy, or graft-versus-host disease. Oral fiber nutrition support may improve overall nutrition, support a normal gut microbiome (bacteria that live in the gut) and/or improve gut function in patients undergoing stem cell transplants.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Kate Farms 1.0, Oral Fiber Supplement, Nutritional Supplement Drink for blood cancers?

The research on oat-based beverages suggests that they are well-accepted by cancer patients and can be used to improve their nutritional intake, which is often inadequate. This indicates that similar nutritional supplements, like Kate Farms 1.0, could potentially support patients with blood cancers by enhancing their overall nutrition. ^{1 2 3 4 5}

Is oral fiber supplementation generally safe for humans?

Dietary fiber intake is generally considered safe and provides health benefits, such as reducing the risk of heart disease, stroke, and certain gastrointestinal issues. Increasing fiber intake can also help with weight loss and improve blood sugar control in both diabetic and non-diabetic individuals. ^{2 3 6 7 8}

How does the treatment Kate Farms 1.0 differ from other treatments for blood cancers?

Kate Farms 1.0 is unique because it is an oral fiber nutritional supplement, which may offer supportive care by potentially improving gut health and nutrient intake, unlike traditional cancer treatments that focus on directly targeting cancer cells. ^{2 8 9 10 11}

Research Team

David Fredricks

Principal Investigator

Fred Hutch/University of Washington Cancer Consortium

Eligibility Criteria

This trial is for adults who are about to have a stem cell transplant for blood cancer and will be hospitalized for it. They must understand the study and agree to participate. People with major uncontrolled psychiatric issues, those already on tube or IV nutrition, or with physical barriers to nasal feeding tubes can't join.

Inclusion Criteria

I am scheduled for a stem cell transplant that will require a hospital stay.

I am scheduled for a stem cell transplant that requires a hospital stay.

Able to provide written informed consent prior to initiation of any study procedures

Exclusion Criteria

Major psychiatric diagnosis that impairs cognitive functioning or is not controlled at the time of the approach, as judged by the patient's medical team

I cannot have a feeding tube placed through my nose due to physical restrictions.

I am currently on tube feeding or IV nutrition.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-treatment

Participants receive fiber supplementation orally or enterally starting 14 to 5 days prior to standard of care conditioning chemotherapy

1-2 weeks

Treatment

Participants continue fiber supplementation until discharge from the hospital, with possible parenteral or enteral nutrition support

Until hospital discharge

Follow-up

Participants are monitored for safety and effectiveness after treatment, with follow-up visits at days 42, 60, and 90 post-transplant

Up to 90 days following transplant

3 visits (in-person)

Treatment Details

Interventions

• Kate Farms 1.0
• Nutritional Supplement Drink
• Standard of Care Nutritional Support

Trial Overview The study is testing if giving nutritional support through a nose-to-gut feeding tube early on helps patients better tolerate their stem cell transplant compared to standard care. It includes using Kate Farms formula and tracking patient experiences via surveys.

Participant Groups

Group I: Supportive care (Fiber) [Current study activity] Experimental Treatment 5 Interventions

Patients receive fiber supplementation PO or enterally starting 14 to 5 days prior to standard of care conditioning chemotherapy and continuing until discharge from the hospital. Stool will be collected at different time points throughout the study. Patients may also undergo blood sample collection throughout the study.

Group II: Arm I (enteral nutrition) [Discontinued in January 2024] Experimental Treatment 2 Interventions

Patients receive enteral nutrition via nasoenteric feeding tube starting on day 1 until hospital discharge.

Group III: Arm II (standard of care) [Discontinued in January 2024] Active Control 2 Interventions

Patients receive standard of care nutritional support.

Kate Farms 1.0 is already approved in United States for the following indications:

Approved in United States as Kate Farms 1.0 for:

• Nutritional Support for Patients Undergoing Donor Stem Cell Transplantation for Hematological Malignancies

Who Is Running the Clinical Trial?

Fred Hutchinson Cancer Research Center

Lead Sponsor

Trials

444

Recruited

148,000+

Fred Hutchinson Cancer Center

Lead Sponsor

Trials

583

Recruited

1,341,000+

Findings from Research

Oat-based beverages were well accepted by both cancer patients and healthy participants, indicating their potential as nutritious products for improving nutrient intake in cancer care.

Patients with cancer found the beverages slightly too sweet but appreciated the flavor intensity, suggesting that oat-based drinks can be tailored to meet their preferences while also being fortified with nutrients like protein and fish oil.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptance of oat-based beverages tailored for patients with cancer. Enriquez Fernandez, BE., Klassen, P., Mazurak, V., et al.[2021]

While some studies suggest a negative association between dietary fiber intake and colon cancer rates, the evidence remains inconsistent and inconclusive, with some studies even indicating a potential positive association in certain populations.

Despite the lack of definitive proof that fiber protects against colorectal cancer, dietary guidelines promoting increased consumption of fiber-rich foods like cereals, fruits, and vegetables are still recommended as they are unlikely to cause harm and may contribute to overall health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fiber intake in different populations and colon cancer risk. McKeown-Eyssen, GE.[2019]

In the Wheat Bran Fiber trial involving participants with a baseline average fiber intake of 17.5 grams per day, no significant effect of high-fiber supplementation on the recurrence of colorectal adenomas was observed.

Baseline fiber intake did not influence adenoma recurrence rates, nor did it modify the effects of the treatment groups, indicating that the fiber levels consumed may have been adequate to prevent recurrence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Baseline dietary fiber intake and colorectal adenoma recurrence in the wheat bran fiber randomized trial. Jacobs, ET., Giuliano, AR., Roe, DJ., et al.[2019]

This preparatory study involving 136 gynecological cancer patients aimed to evaluate the feasibility of a dietary fiber intervention during pelvic radiotherapy, with a participation rate of 63% for primary outcomes, indicating a reasonable level of engagement despite the challenges of treatment.

Adjustments such as using fiber capsules instead of powder and providing timely information significantly improved participant retention, achieving a 100% participation rate for the last 12 patients, which will help inform the design of a larger-scale study.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Preparatory Study for a Randomized Controlled Trial of Dietary Fiber Intake During Adult Pelvic Radiotherapy. Ahlin, R., Bergmark, K., Bull, C., et al.[2023]

In a Phase III clinical trial with 1208 participants, increasing fiber intake from wheat bran supplements did not show any protective effect against the recurrence of colorectal adenomas, indicating that higher fiber consumption may not reduce this risk.

The study found no significant difference in adenoma recurrence based on total fiber intake, suggesting that a high-fiber diet, particularly one rich in cereal fiber, does not lower the risk of colorectal adenoma recurrence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intake of supplemental and total fiber and risk of colorectal adenoma recurrence in the wheat bran fiber trial. Jacobs, ET., Giuliano, AR., Roe, DJ., et al.[2017]

High dietary fiber intake is linked to a significantly lower risk of various health issues, including coronary heart disease, stroke, and diabetes, highlighting its importance for overall health.

Increasing fiber intake not only lowers blood pressure and cholesterol levels but also improves glycemia and insulin sensitivity, making it beneficial for both diabetic and non-diabetic individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health benefits of dietary fiber. Anderson, JW., Baird, P., Davis, RH., et al.[2023]

In a study of 364,856 participants from the UK Biobank over a median follow-up of 8.8 years, higher dietary fiber intake was associated with a 10% lower risk of developing cancer overall, particularly for cervical, esophageal, lung, bladder, and kidney cancers.

The research highlighted that specific sources of dietary fiber, especially from cereals and fruits and vegetables, contributed to this reduced cancer risk, with notable associations for lung cancer observed primarily in current and former smokers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Different Sources of Fiber Intake and Risk of 17 Specific Cancers and All Cancers Combined: Prospective Study of 364,856 Participants in UK Biobank. Parra-Soto, S., Araya, C., Knight, K., et al.[2023]

In a study involving 94 participants (45 postpolypectomy and 49 nonpolyp), oat-bran supplementation did not show any significant advantages over wheat-bran in reducing colon cancer risk factors, as measured by colonic biopsies.

However, oat bran did significantly lower fecal pH, indicating increased colonic fermentation, but this change did not correlate with increased hydrogen production or improved risk factors compared to wheat bran.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Colonic fermentation and markers of colorectal-cancer risk. Kashtan, H., Stern, HS., Jenkins, DJ., et al.[2018]

A high-fiber diet (HF) significantly reduced the weight and multiplicity of tumors in rats compared to a low-fiber diet (LF), despite similar tumor incidence and latency, suggesting that fiber may have a protective effect against tumor growth.

The HF diet led to a threefold increase in the excretion of estrogens in feces, indicating that it may interrupt the enterohepatic circulation of estrogens, which could contribute to lower tumor weights, although plasma estrogen levels remained unchanged.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of wheat bran on NMU-induced mammary tumor development, plasma estrogen levels and estrogen excretion in female rats. Arts, CJ., de Bie, AT., van den Berg, H., et al.[2019]

Animal studies indicate that supplementary fiber can inhibit the development of breast tumors, although this effect does not appear to be linked to estrogen modulation.

Human studies show mixed results regarding fiber's impact on estrogen levels, suggesting that other components in fiber, like isoflavones and phytate, may play a key role in its potential anti-cancer effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary fiber and breast cancer. Cohen, LA.[2022]

A review of 76 studies involving 92 cancer patients revealed that 87% of adverse events (AEs) from health food (HF) intake were due to the foods themselves, with 70% of identified cases being severe (grades 3 to 5).

Common severe AEs included hepatic and respiratory disorders, particularly in Japanese patients, and notable issues like hypercalcemia and bacterial infections were linked to specific health food products.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Systematic Review of Case Reports on the Adverse Events Due to Health Food Intake by Cancer Patients]. Kojima, A., Sato, Y., Nishijima, C., et al.[2020]

References

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

Acceptance of oat-based beverages tailored for patients with cancer. [2021]

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

Fiber intake in different populations and colon cancer risk. [2019]

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

Baseline dietary fiber intake and colorectal adenoma recurrence in the wheat bran fiber randomized trial. [2019]

4. Switzerland pubmed.ncbi.nlm.nih.gov

A Preparatory Study for a Randomized Controlled Trial of Dietary Fiber Intake During Adult Pelvic Radiotherapy. [2023]

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

Intake of supplemental and total fiber and risk of colorectal adenoma recurrence in the wheat bran fiber trial. [2017]

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

Health benefits of dietary fiber. [2023]

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

Different Sources of Fiber Intake and Risk of 17 Specific Cancers and All Cancers Combined: Prospective Study of 364,856 Participants in UK Biobank. [2023]

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

Colonic fermentation and markers of colorectal-cancer risk. [2018]

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

Influence of wheat bran on NMU-induced mammary tumor development, plasma estrogen levels and estrogen excretion in female rats. [2019]

10. Greece pubmed.ncbi.nlm.nih.gov

Dietary fiber and breast cancer. [2022]

11. Japan pubmed.ncbi.nlm.nih.gov

[Systematic Review of Case Reports on the Adverse Events Due to Health Food Intake by Cancer Patients]. [2020]