Hematopoietic and Lymphatic System NeoplasmNCT07664670
The High Fiber Program to Increase Fiber Intake Among Patients Undergoing Allogeneic Hematopoietic Cell Transplant
A study testing Biospecimen Collection, Dietary Intervention and Questionnaire Administration in people with Hematopoietic and Lymphatic System Neoplasm, run by City of Hope Medical Center at 1 site in United States.
Trial summary
This clinical trial studies whether the High Fiber Program can be used to increase fiber intake in patients undergoing allogeneic hematopoietic cell transplant (HCT). Allogeneic HCT is a procedure in which a person receives blood-forming stem cells (cells from which all blood cells develop) from a genetically similar… 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?
- Biospecimen Collection, Dietary Intervention and Questionnaire Administration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Feb 2027to 3 Jun 2028
- 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
- MAIN INCLUSION: Documented informed consent of the participant and/or legally authorized representative
- MAIN INCLUSION: Age: ≥ 18 years
- Patients ≥ 75 years of age that are otherwise eligible to undergo allogeneic HCT are included
- MAIN INCLUSION: Karnofsky performance status ≥ 70%
- MAIN INCLUSION: Within healthy BMI range 18-29 at the time of consent
- MAIN INCLUSION: Ability to read and understand English for questionnaires
Show all 13Show fewer
- MAIN INCLUSION: Patients receiving myeloablative or reduced intensity conditioning regimens
- MAIN INCLUSION: Adequate organ function consistent with institutional standards for HCT
- MAIN INCLUSION: Patients must be scheduled to receive HCT within 45 days of consent
- MAIN INCLUSION: Women of childbearing potential (WOCBP): negative urine or serum pregnancy test (within 45 days prior to the start of conditioning)
- If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
- MAIN INCLUSION: Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 6 months post-HCT
- Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for > 1 year (women only)
Who cannot join
- MAIN EXCLUSION: Clinically significant uncontrolled illness
- MAIN EXCLUSION: Active infection requiring antibiotics
- MAIN EXCLUSION: History of chronic gastrointestinal conditions such as inflammatory bowel disease or Crohn's disease
- MAIN EXCLUSION: Medical contraindications to incorporating fiber in their diet as determined by the treating physician
- MAIN EXCLUSION: Self-reported major dietary restrictions limiting fiber intake
- MAIN EXCLUSION: Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures
- MAIN EXCLUSION: Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
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
City of Hope Medical Center
Duarte, California, 91010
Ryotaro Nakamura, RNakamura@coh.org
6262184673
About this study
Official title: Pilot Study to Evaluate the Feasibility of High Fiber Program in Patients Undergoing Allogeneic Hematopoietic Cell Transplant (HCT)
This clinical trial studies whether the High Fiber Program can be used to increase fiber intake in patients undergoing allogeneic hematopoietic cell transplant (HCT). Allogeneic HCT is a procedure in which a person receives blood-forming stem cells (cells from which all blood cells develop) from a genetically similar, but not identical, donor. This is often a sister or brother, but could be an unrelated donor. It is a potentially curative therapy for many conditions that affect the blood and blood-forming organs, but many patients must manage post-transplant complications, especially graft versus host disease (GVHD). GVHD occurs when the transplanted cells from a donor attack the body's normal cells causing skin rash or blisters, dry mouth, or dry eyes. The environment and health of the gut is important in allogeneic HCT patients, with an unhealthy gut environment and/or health leading to inflammation and possibly GVHD. Research has shown that diets high in fiber may improve the environment and health of the gut as well as outcomes following transplant; however, fiber intake remains low among patients. The High Fiber Program is a dietitian-led counseling program which teaches patients how to introduce high fiber foods into their diet and identify food choices and personalized strategies that will help them change their diet. The High Fiber Program may be an effective way to increase fiber intake in patients undergoing allogeneic HCT.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the feasibility of executing the High Fiber Program in HCT patients.
II. To estimate the proportion of patients who restore fiber intake to baseline levels by day 60 post-HCT.
SECONDARY OBJECTIVES:
- To estimate the median number of days post-HCT when allogeneic HCT (alloHCT) patients achieve baseline fiber intake levels.
II. To obtain estimates of fiber intake in the pre-HCT period and over time in alloHCT patients on the High Fiber Program.
III. To evaluate the variety of fiber sources that patients have included in their diet by day 100.
IV. To evaluate the tolerability of introducing fiber into patients' diets based on when patients resume fiber intake post-transplant and the frequency of medications for controlling gastrointestinal symptoms.
- To characterize toxicities associated with introducing fiber into patients' diets.
VI. To evaluate the median day of onset of acute GVHD and cumulative incidence of grade 2 or higher acute graft-versus (vs)-host disease (GVHD), per Mount Sinai Acute Graft Versus Host Disease International Consortium Grading System (MAGIC) criteria, at day +100 post-HCT, including incidence and severity of lower gastrointestinal acute GVHD.
VII. To evaluate incidence and severity of infections per Blood and Marrow Transplant Clinical Trials Network (BMT CTN) criteria, including bloodstream infections, up to day 100.
VIII. To obtain estimates of correlation between fiber intake and quality of life scores at day 100 post-HCT.
IX. To estimate the proportion of patients who achieve a fiber intake of at least 25g on at least one day by day 100 post-HCT.
- To evaluate the cumulative incidence of chronic GVHD at 180 days, 1 year and 2 years post-HCT in patients on the High Fiber Program.
XI. To estimate overall survival (OS) and cumulative incidence of relapse/progression and non-relapse mortality at 100 days, 1 year and 2 years post-HCT in patients on the High Fiber Program.
EXPLORATORY OBJECTIVES:
- To assess the feasibility of obtaining patient reported side effects and medications for symptom relief during the pre-screening period.
II. To assess how fiber intake influences immune reconstitution pattern over the course of therapy.
III. To evaluate how fiber intake relates to fecal/intestinal microbiome composition over the course of therapy.
IV. To assess relationships between fiber intake and serum inflammatory cytokines over the course of therapy.
- To assess relationships between fiber intake and acute GVHD biomarkers, especially Reg3a produced by intestinal enterocytes.
VI. To evaluate how fiber intake relates to fecal metabolite levels over the course of therapy.
VII. To evaluate whether fiber intake relates to calorie intake over the course of therapy.
OUTLINE:
Patients attend five or six High Fiber Program dietitian-lead counseling sessions up to 30 days and/or 18 days prior to scheduled HCT, upon admission to inpatient care, at discharge, at day 42 post-transplant (approximately 20-30 days post-discharge), and at day 60 post-transplant. Patients also meet with High Fiber Program dietitian once a week (QW) and select food options from Fiber Aware Menu during admission. Additionally, patients receive a study booklet and undergo blood sample collection on study.
After completion of study intervention, patients are followed up on days 72, 100, and 180 and years 1 and 2.
- Being tested
- Biospecimen Collection, Dietary Intervention, Questionnaire Administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection
Undergo blood sample collection
Dietary InterventionOther
Also called Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition Interventions
Attend High Fiber Program counseling sessions
Dietary InterventionOther
Also called Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition Interventions
Attend High Fiber Program weekly sessions
Dietary InterventionOther
Also called Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition Interventions
Make Fiber Aware Menu food selections
Dietary InterventionOther
Also called Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition Interventions
Receive study booklet
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Supportive care (High Fiber Program) | Experimental | Patients attend five or six High Fiber Program dietitian-lead counseling sessions up to 30 days and/or 18 days prior to scheduled HCT, upon admission to inpatient care, at discharge, at day 42 post-transplant (approximately 20-30 days post-discharge), and at day 60 post-transplant. Patients also meet with High Fiber Program dietitian QW and select food options from Fiber Aware Menu during admission. Additionally, patients receive a study booklet and undergo blood sample collection on study. Receives: Procedure: Biospecimen Collection; Other: Dietary Intervention; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of scheduled dietary counseling sessions attended and withdrawal status (Feasibility)
Feasibility in each patient will be assessed based on patient participating in ≥ 80% of scheduled dietary counseling sessions by the study dietitian and not withdrawing by day 60. Point estimates and corresponding 95% confidence intervals will be reported. Will be estimated with exact binomial 95% confidence intervals.
Measured: Up to day 60
Highest daily fiber intake
Point estimates and corresponding 95% confidence intervals will be reported. Will be estimated with exact binomial confidence intervals. Distributions of baseline and day +60 intake will be summarized.
Measured: Baseline up to day 60
Secondary outcomes (14)
Longitudinal dietary fiber intake
Point estimates and corresponding 95% confidence intervals will be reported. Fiber intake trajectories will be analyzed using linear mixed-effects models with random intercepts for participants.
Measured: Pre-hematopoietic cell transplant up to day +100 post-transplant
Number of types of plant-based fiber sources included in diet
Point estimates and corresponding 95% confidence intervals will be reported. The number and diversity of fiber sources will be summarized.
Measured: Up to day 100
Duration that patients were not able to consume fiber
Point estimates and corresponding 95% confidence intervals will be reported. Will be analyzed using Kaplan-Meier methods. Median time and 95% confidence intervals will be reported.
Measured: Up to day +100 post-transplant
Incidence of gastrointestinal toxicities and attribution to fiber intake
Point estimates and corresponding 95% confidence intervals will be reported. Assessed per Common Terminology Criteria for Adverse Events (CTCAE) version (v) 6.
Measured: Up to day +100 post-transplant
Frequency and doses of medications for constipation, diarrhea or any other gastrointestinal discomfort
Point estimates and corresponding 95% confidence intervals will be reported.
Measured: Up to day +100 post-transplant
Incidence of systemic toxicities and attribution to fiber intake
Point estimates and corresponding 95% confidence intervals will be reported. Assessed per CTCAE v6.
Measured: Up to day +100 post-transplant
Incidence of acute grafter versus host disease (GVHD)
Point estimates and corresponding 95% confidence intervals will be reported. Cumulative incidence of acute GVHD by day +100 will be estimated using competing-risk methods, with death without GVHD treated as a competing event, if appropriate.
Measured: Up to day +100 post-transplant
Involvement of lower gastrointestinal acute GVHD
Point estimates and corresponding 95% confidence intervals will be reported. Assessed per Mount Sinai Acute Graft Versus Host Disease International Consortium Grading System consensus criteria.
Measured: Up to day +100 post-transplant
Incidence of severity of infections
Point estimates and corresponding 95% confidence intervals will be reported. Will be assessed per Blood and Marrow Transplant Clinical Trials Network criteria.
Measured: Up to day +100 post-transplant
Quality of life score
Point estimates and corresponding 95% confidence intervals will be reported. Associations between fiber intake and quality of life measures will be evaluated using correlation and exploratory regression.
Measured: At day +100 post-transplant
Incidence of chronic GVHD
Point estimates and corresponding 95% confidence intervals will be reported. Will be estimated using competing-risk methods.
Measured: At day +180, 1 year and 2 years post-transplant
Overall survival
Point estimates and corresponding 95% confidence intervals will be reported. Will be analyzed using Kaplan-Meier methods.
Measured: At day +100 and 1 year and 2 years post-transplant
Relapse
Point estimates and corresponding 95% confidence intervals will be reported. Will be analyzed using cumulative incidence functions.
Measured: At day +100 and 1 year and 2 years post-transplant
Non-relapse mortality
Point estimates and corresponding 95% confidence intervals will be reported. Will be analyzed using cumulative incidence functions.
Measured: At day +100 and 1 year and 2 years post-transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study start13 Feb 2027 (estimated)
- Primary completion3 Jun 2028 (estimated)
- Study completion3 Jun 2028 (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 City of Hope Medical 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Ryotaro Nakamura, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07664670
- Sponsor's protocol ID
- 25887
- Other IDs
- NCI-2026-03804, 25887, P30CA033572
- Status last verified
- Nov 2026
- First submitted
- 9 Jun 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Evaluate the Feasibility of High Fiber Program in Patients Undergoing Allogeneic Hematopoietic Cell Transplant (HCT)
- ClinicalTrials.gov ID
- NCT07664670
- Acronym / sponsor ID
- 25887
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 13 Feb 2027 (estimated)
- Primary completion
- 3 Jun 2028 (estimated)
- Study completion
- 3 Jun 2028 (estimated)
- First posted
- 24 Jun 2026 (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 studies whether the High Fiber Program can be used to increase fiber intake in patients undergoing allogeneic hematopoietic cell transplant (HCT). Allogeneic HCT is a procedure in which a person receives blood-forming stem cells (cells from which all blood cells develop) from a genetically similar, but not identical, donor. This is often a sister or brother, but could be an unrelated donor. It is a potentially curative therapy for many conditions that affect the blood and blood-forming organs, but many patients must manage post-transplant complications, especially graft versus host disease (GVHD). GVHD occurs when the transplanted cells from a donor attack the body's normal cells causing skin rash or blisters, dry mouth, or dry eyes. The environment and health of the gut is important in allogeneic HCT patients, with an unhealthy gut environment and/or health leading to inflammation and possibly GVHD. Research has shown that diets high in fiber may improve the environment and health of the gut as well as outcomes following transplant; however, fiber intake remains low among patients. The High Fiber Program is a dietitian-led counseling program which teaches patients how to introduce high fiber foods into their diet and identify food choices and personalized strategies that will help them change their diet. The High Fiber Program may be an effective way to increase fiber intake in patients undergoing allogeneic HCT.
Detailed description
PRIMARY OBJECTIVES:
- To determine the feasibility of executing the High Fiber Program in HCT patients.
II. To estimate the proportion of patients who restore fiber intake to baseline levels by day 60 post-HCT.
SECONDARY OBJECTIVES:
- To estimate the median number of days post-HCT when allogeneic HCT (alloHCT) patients achieve baseline fiber intake levels.
II. To obtain estimates of fiber intake in the pre-HCT period and over time in alloHCT patients on the High Fiber Program.
III. To evaluate the variety of fiber sources that patients have included in their diet by day 100.
IV. To evaluate the tolerability of introducing fiber into patients' diets based on when patients resume fiber intake post-transplant and the frequency of medications for controlling gastrointestinal symptoms.
- To characterize toxicities associated with introducing fiber into patients' diets.
VI. To evaluate the median day of onset of acute GVHD and cumulative incidence of grade 2 or higher acute graft-versus (vs)-host disease (GVHD), per Mount Sinai Acute Graft Versus Host Disease International Consortium Grading System (MAGIC) criteria, at day +100 post-HCT, including incidence and severity of lower gastrointestinal acute GVHD.
VII. To evaluate incidence and severity of infections per Blood and Marrow Transplant Clinical Trials Network (BMT CTN) criteria, including bloodstream infections, up to day 100.
VIII. To obtain estimates of correlation between fiber intake and quality of life scores at day 100 post-HCT.
IX. To estimate the proportion of patients who achieve a fiber intake of at least 25g on at least one day by day 100 post-HCT.
- To evaluate the cumulative incidence of chronic GVHD at 180 days, 1 year and 2 years post-HCT in patients on the High Fiber Program.
XI. To estimate overall survival (OS) and cumulative incidence of relapse/progression and non-relapse mortality at 100 days, 1 year and 2 years post-HCT in patients on the High Fiber Program.
EXPLORATORY OBJECTIVES:
- To assess the feasibility of obtaining patient reported side effects and medications for symptom relief during the pre-screening period.
II. To assess how fiber intake influences immune reconstitution pattern over the course of therapy.
III. To evaluate how fiber intake relates to fecal/intestinal microbiome composition over the course of therapy.
IV. To assess relationships between fiber intake and serum inflammatory cytokines over the course of therapy.
- To assess relationships between fiber intake and acute GVHD biomarkers, especially Reg3a produced by intestinal enterocytes.
VI. To evaluate how fiber intake relates to fecal metabolite levels over the course of therapy.
VII. To evaluate whether fiber intake relates to calorie intake over the course of therapy.
OUTLINE:
Patients attend five or six High Fiber Program dietitian-lead counseling sessions up to 30 days and/or 18 days prior to scheduled HCT, upon admission to inpatient care, at discharge, at day 42 post-transplant (approximately 20-30 days post-discharge), and at day 60 post-transplant. Patients also meet with High Fiber Program dietitian once a week (QW) and select food options from Fiber Aware Menu during admission. Additionally, patients receive a study booklet and undergo blood sample collection on study.
After completion of study intervention, patients are followed up on days 72, 100, and 180 and years 1 and 2.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive care (High Fiber Program) | Experimental | Procedure: Biospecimen Collection, Other: Dietary Intervention, Other: Questionnaire AdministrationPatients attend five or six High Fiber Program dietitian-lead counseling sessions up to 30 days and/or 18 days prior to scheduled HCT, upon admission to inpatient care, at discharge, at day 42 post-transplant (approximately 20-30 days post-discharge), and at day 60 post-transplant. Patients also meet with High Fiber Program dietitian QW and select food options from Fiber Aware Menu during admission. Additionally, patients receive a study booklet and undergo blood sample collection on study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- MAIN INCLUSION: Documented informed consent of the participant and/or legally authorized representative
- MAIN INCLUSION: Age: ≥ 18 years
- MAIN INCLUSION: Karnofsky performance status ≥ 70%
- MAIN INCLUSION: Within healthy BMI range 18-29 at the time of consent
- MAIN INCLUSION: Ability to read and understand English for questionnaires
Key exclusion criteria (7 listed)
- MAIN EXCLUSION: Clinically significant uncontrolled illness
- MAIN EXCLUSION: Active infection requiring antibiotics
- MAIN EXCLUSION: History of chronic gastrointestinal conditions such as inflammatory bowel disease or Crohn's disease
- MAIN EXCLUSION: Medical contraindications to incorporating fiber in their diet as determined by the treating physician
- MAIN EXCLUSION: Self-reported major dietary restrictions limiting fiber intake
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 |
|---|---|---|
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen CollectionUndergo blood sample collection | Procedure or surgery | Supportive care (High Fiber Program) |
| Dietary InterventionAlso: Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition InterventionsAttend High Fiber Program counseling sessions | Other | Supportive care (High Fiber Program) |
| Dietary InterventionAlso: Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition InterventionsAttend High Fiber Program weekly sessions | Other | Supportive care (High Fiber Program) |
| Dietary InterventionAlso: Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition InterventionsMake Fiber Aware Menu food selections | Other | Supportive care (High Fiber Program) |
| Dietary InterventionAlso: Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition InterventionsReceive study booklet | Other | Supportive care (High Fiber Program) |
| Questionnaire AdministrationAncillary studies | Other | Supportive care (High Fiber Program) |
Primary outcome
Percent of scheduled dietary counseling sessions attended and withdrawal status (Feasibility)
Time frame: Up to day 60
Feasibility in each patient will be assessed based on patient participating in ≥ 80% of scheduled dietary counseling sessions by the study dietitian and not withdrawing by day 60. Point estimates and corresponding 95% confidence intervals will be reported. Will be estimated with exact binomial 95% confidence intervals.
Highest daily fiber intake
Time frame: Baseline up to day 60
Point estimates and corresponding 95% confidence intervals will be reported. Will be estimated with exact binomial confidence intervals. Distributions of baseline and day +60 intake will be summarized.
14 secondary outcomes
Longitudinal dietary fiber intake
Time frame: Pre-hematopoietic cell transplant up to day +100 post-transplant
Number of types of plant-based fiber sources included in diet
Time frame: Up to day 100
Duration that patients were not able to consume fiber
Time frame: Up to day +100 post-transplant
Incidence of gastrointestinal toxicities and attribution to fiber intake
Time frame: Up to day +100 post-transplant
Frequency and doses of medications for constipation, diarrhea or any other gastrointestinal discomfort
Time frame: Up to day +100 post-transplant
Incidence of systemic toxicities and attribution to fiber intake
Time frame: Up to day +100 post-transplant
Incidence of acute grafter versus host disease (GVHD)
Time frame: Up to day +100 post-transplant
Involvement of lower gastrointestinal acute GVHD
Time frame: Up to day +100 post-transplant
Incidence of severity of infections
Time frame: Up to day +100 post-transplant
Quality of life score
Time frame: At day +100 post-transplant
Incidence of chronic GVHD
Time frame: At day +180, 1 year and 2 years post-transplant
Overall survival
Time frame: At day +100 and 1 year and 2 years post-transplant
Relapse
Time frame: At day +100 and 1 year and 2 years post-transplant
Non-relapse mortality
Time frame: At day +100 and 1 year and 2 years post-transplant
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 5 Nov 2026.
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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.
Ryotaro Nakamura principal investigator
City of Hope Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biospecimen Collection, Dietary Intervention and Questionnaire Administration in people with Hematopoietic and Lymphatic System Neoplasm, run by City of Hope Medical 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 13 inclusion and 7 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 5 Nov 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 Jenny Paredes, PhD (6262184673, jeparedes@coh.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of scheduled dietary counseling sessions attended and withdrawal status (Feasibility) (time frame: Up to day 60). The study lists 2 primary outcomes in all. 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 5 Nov 2026.