Hematopoietic and Lymphatic System NeoplasmNCT04829136
Sustained Oral Fiber Supplementation for Patients Undergoing Treatment for Hematological Malignancies
A study testing Kate Farms 1.0, Survey Administration and Dietary Supplement in people with Hematopoietic and Lymphatic System Neoplasm, run by Fred Hutchinson Cancer Center at 1 site in United States.
Trial summary
This clinical trial examines sustained oral fiber supplementation for patients undergoing treatment for hematological malignancies. Patients undergoing cancer treatment, including donor stem cell transplantation often develop oral and gastrointestinal damage from chemotherapy, radiotherapy, or graft-versus-host… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematopoietic and Lymphatic System Neoplasm
- What is being tested?
- Kate Farms 1.0, Survey Administration and Dietary Supplement
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jun 2022to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to provide written informed consent prior to initiation of any study procedures
- Any diagnosed hematological malignancy
- At least 18 years of age
- Planned treatment at Fred Hutchinson Cancer Center and/or University of Washington Medical Center
Who cannot join
- 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
- Pregnant or breastfeeding. Pregnancy test is obtained as part of pre-transplant evaluation in women of child-bearing potential at arrival to transplant and again within 7 days of conditioning and will be confirmed as negative by review of the chart
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
David Fredricks, 206-667-1935, dfredric@fredhutch.org
David Fredricks
About this study
Official title: Feasibility of Implementing Sustained Oral Fiber Supplementation for Patients Undergoing Treatment for Hematological Malignancies
This clinical trial examines sustained oral fiber supplementation for patients undergoing treatment for hematological malignancies. Patients undergoing cancer treatment, including 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 treatment for hematological malignancies.
Read the detailed description
OUTLINE:
Current study design: Patients receive fiber supplementation orally (PO) or enterally starting 14 to 5 days prior to standard of care treatment and continuing until day 42 post-treatment. Patients who are not able to receive sufficient nutrition by mouth may receive parenteral nutrition or enteral nutrition by feeding tube from the hospital. Patients may undergo blood sample collection throughout the study.
Previous study design: Before this study was amended in January 2024, patients were randomized to 1 of 2 arms.
Previous Arm I: Patients received enteral nutrition via nasoenteric feeding tube starting on day 1 until hospital discharge.
Previous Arm II: Patients received standard of care nutritional support.
After completion of study treatment, patients are followed up at days 42, 60 and 90 days post transplant.
- Being tested
- Kate Farms 1.0, Standard of Care Nutritional Support, Survey Administration, Dietary Supplement, Biospecimen Collection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kate Farms 1.0Dietary supplement
Also called Polymeric Enteral Nutrition Formula
Given enteral nutrition via nasoenteric feeding
Standard of Care Nutritional SupportDietary supplement
Also called hyperalimentation, parenteral nutrition, Total Parenteral Nutrition, TPN
Given standard of care, which may be parenteral nutrition
Survey AdministrationOther
Ancillary studies
Dietary SupplementDietary supplement
Also called nutritional supplement, supplemental nutrition, Supplements
Receive fiber supplementation orally or enterally
Biospecimen CollectionProcedure or surgery
Undergo collection of blood and stool samples
Electronic Health Record ReviewOther
Ancillary studies
Fiber and Dietary AssessmentsOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (enteral nutrition) [Discontinued in January 2024] | Experimental | Patients receive enteral nutrition via nasoenteric feeding tube starting on day 1 until hospital discharge. Receives: Dietary Supplement: Kate Farms 1.0; Other: Survey Administration |
| Arm II (standard of care) [Discontinued in January 2024] | Active comparator | Patients receive standard of care nutritional support. Receives: Dietary Supplement: Standard of Care Nutritional Support; Other: Survey Administration |
| Supportive care (Fiber) [Current study activity] | Experimental | Patients receive fiber supplementation PO or enterally starting 14 to 5 days prior to standard of care treatment and continuing until day 42 post-treatment. Stool will be collected at different time points throughout the study. Patients may also undergo blood sample collection throughout the study. Receives: Other: Survey Administration; Dietary Supplement: Dietary Supplement; Procedure: Biospecimen Collection; Other: Electronic Health Record Review; Other: Fiber and Dietary Assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study participation rates
The proportion of eligible patients who consent to enroll in the study will be computed based on the number approached and estimated with 95% confidence intervals.
Measured: Assessed at consenting
Secondary outcomes (6)
Number of days receiving any amount of fiber
Measured: Up to 90 days following treatment
Number of days receiving at least 10 grams of fiber
Measured: Up to 90 days following treatment
Number of days receiving at least 25 grams of fiber
Measured: Up to 90 days following treatment
Tolerance of initiating and maintaining oral fiber intake
Tolerance of initiating and maintaining oral fiber intake (or via enteral nutrition) will be calculated as delivery of the intended amount on each day that nutritional supplementation was indicated.
Measured: Up to 90 days following treatment
Level of comfort/distress attributed to initiating and maintaining oral fiber intake
The post-discharge questions measuring level of comfort or distress experienced with each nutritional treatment will be tabulated.
Measured: Up to 90 days following treatment
Incidence of adverse events
Will assess safety including diarrhea, abdominal pain, bloating.
Measured: Up to 90 days following treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2021
- Study start22 Jun 2022
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic and Lymphatic System NeoplasmStudies of the same condition, open and under way.
- More trials run by Fred Hutchinson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Fredricks, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04829136
- Sponsor's protocol ID
- RG1121363
- Other IDs
- NCI-2021-00842, 10599
- Status last verified
- Aug 2026
- First submitted
- 26 Feb 2021
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Implementing Sustained Oral Fiber Supplementation for Patients Undergoing Treatment for Hematological Malignancies
- ClinicalTrials.gov ID
- NCT04829136
- Acronym / sponsor ID
- RG1121363
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Study start
- 22 Jun 2022 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 2 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial examines sustained oral fiber supplementation for patients undergoing treatment for hematological malignancies. Patients undergoing cancer treatment, including 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 treatment for hematological malignancies.
Detailed description
OUTLINE:
Current study design: Patients receive fiber supplementation orally (PO) or enterally starting 14 to 5 days prior to standard of care treatment and continuing until day 42 post-treatment. Patients who are not able to receive sufficient nutrition by mouth may receive parenteral nutrition or enteral nutrition by feeding tube from the hospital. Patients may undergo blood sample collection throughout the study.
Previous study design: Before this study was amended in January 2024, patients were randomized to 1 of 2 arms.
Previous Arm I: Patients received enteral nutrition via nasoenteric feeding tube starting on day 1 until hospital discharge.
Previous Arm II: Patients received standard of care nutritional support.
After completion of study treatment, patients are followed up at days 42, 60 and 90 days post transplant.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm I (enteral nutrition) [Discontinued in January 2024] | Experimental | Dietary Supplement: Kate Farms 1.0, Other: Survey AdministrationPatients receive enteral nutrition via nasoenteric feeding tube starting on day 1 until hospital discharge. |
| Arm II (standard of care) [Discontinued in January 2024] | Active comparator | Dietary Supplement: Standard of Care Nutritional Support, Other: Survey AdministrationPatients receive standard of care nutritional support. |
| Supportive care (Fiber) [Current study activity] | Experimental | Other: Survey Administration, Dietary Supplement: Dietary Supplement, Procedure: Biospecimen Collection, Other: Electronic Health Record Review, Other: Fiber and Dietary AssessmentsPatients receive fiber supplementation PO or enterally starting 14 to 5 days prior to standard of care treatment and continuing until day 42 post-treatment. Stool will be collected at different time points throughout the study. Patients may also undergo blood sample collection throughout the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Able to provide written informed consent prior to initiation of any study procedures
- Any diagnosed hematological malignancy
- At least 18 years of age
- Planned treatment at Fred Hutchinson Cancer Center and/or University of Washington Medical Center
Key exclusion criteria (2 listed)
- 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
- Pregnant or breastfeeding. Pregnancy test is obtained as part of pre-transplant evaluation in women of child-bearing potential at arrival to transplant and again within 7 days of conditioning and will be confirmed as negative by review of the chart
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kate Farms 1.0Also: Polymeric Enteral Nutrition FormulaGiven enteral nutrition via nasoenteric feeding | Dietary supplement | Arm I (enteral nutrition) [Discontinued in January 2024] |
| Standard of Care Nutritional SupportAlso: hyperalimentation, parenteral nutrition, Total Parenteral Nutrition, TPNGiven standard of care, which may be parenteral nutrition | Dietary supplement | Arm II (standard of care) [Discontinued in January 2024] |
| Survey AdministrationAncillary studies | Other | Arm I (enteral nutrition) [Discontinued in January 2024], Arm II (standard of care) [Discontinued in January 2024], Supportive care (Fiber) [Current study activity] |
| Dietary SupplementAlso: nutritional supplement, supplemental nutrition, SupplementsReceive fiber supplementation orally or enterally | Dietary supplement | Supportive care (Fiber) [Current study activity] |
| Biospecimen CollectionUndergo collection of blood and stool samples | Procedure or surgery | Supportive care (Fiber) [Current study activity] |
| Electronic Health Record ReviewAncillary studies | Other | Supportive care (Fiber) [Current study activity] |
| Fiber and Dietary AssessmentsAncillary studies | Other | Supportive care (Fiber) [Current study activity] |
Primary outcome
Study participation rates
Time frame: Assessed at consenting
The proportion of eligible patients who consent to enroll in the study will be computed based on the number approached and estimated with 95% confidence intervals.
6 secondary outcomes
Number of days receiving any amount of fiber
Time frame: Up to 90 days following treatment
Number of days receiving at least 10 grams of fiber
Time frame: Up to 90 days following treatment
Number of days receiving at least 25 grams of fiber
Time frame: Up to 90 days following treatment
Tolerance of initiating and maintaining oral fiber intake
Time frame: Up to 90 days following treatment
Level of comfort/distress attributed to initiating and maintaining oral fiber intake
Time frame: Up to 90 days following treatment
Incidence of adverse events
Time frame: Up to 90 days following treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David Fredricks principal investigator
Fred Hutch/University of Washington Cancer Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kate Farms 1.0, Survey Administration and Dietary Supplement in people with Hematopoietic and Lymphatic System Neoplasm, run by Fred Hutchinson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David Fredricks (206-667-1935, dfredric@fredhutch.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study participation rates (time frame: Assessed at consenting). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.