The High Fiber Program to Increase Fiber Intake Among Patients Undergoing Allogeneic Hematopoietic Cell Transplant
Pilot Study to Evaluate the Feasibility of High Fiber Program in Patients Undergoing Allogeneic Hematopoietic Cell Transplant (HCT)
Studieoversigt
Status
Status
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Detaljeret beskrivelse
PRIMARY OBJECTIVES:
I. 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:
I. 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.
V. 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.
X. 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:
I. 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.
V. 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.
Undersøgelsestype
Undersøgelsestype
Tilmelding (Anslået)
Tilmelding
Fase
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
Studiekontakt
- Navn: Jenny Paredes, PhD
- Telefonnummer: 6262184673
- E-mail: jeparedes@coh.org
Studiesteder
-
-
California
-
Duarte, California, Forenede Stater, 91010
- City of Hope Medical Center
-
Kontakt:
- Ryotaro Nakamura
- E-mail: RNakamura@coh.org
-
Ledende efterforsker:
- Ryotaro Nakamura
-
Kontakt:
- Telefonnummer: 6262184673
-
-
Deltagelseskriterier
Berettigelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- 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
- 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)
Exclusion Criteria:
- 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)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Antal våben
Våben og indgreb
Deltagergruppe / ArmDeltagergruppe / Arm |
Intervention / BehandlingIntervention / Behandling |
|---|---|
|
Eksperimentel: Supportive care (High Fiber Program)
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.
|
Hjælpestudier
Gennemgå blodprøvetagning
Andre navne:
Attend High Fiber Program counseling sessions
Andre navne:
Attend High Fiber Program weekly sessions
Andre navne:
Make Fiber Aware Menu food selections
Andre navne:
Receive study booklet
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Percent of scheduled dietary counseling sessions attended and withdrawal status (Feasibility)
Tidsramme: 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.
|
Up to day 60
|
|
Highest daily fiber intake
Tidsramme: 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.
|
Baseline up to day 60
|
Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Longitudinal dietary fiber intake
Tidsramme: Pre-hematopoietic cell transplant up to day +100 post-transplant
|
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.
|
Pre-hematopoietic cell transplant up to day +100 post-transplant
|
|
Number of types of plant-based fiber sources included in diet
Tidsramme: Up to day 100
|
Point estimates and corresponding 95% confidence intervals will be reported.
The number and diversity of fiber sources will be summarized.
|
Up to day 100
|
|
Duration that patients were not able to consume fiber
Tidsramme: Up to day +100 post-transplant
|
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.
|
Up to day +100 post-transplant
|
|
Incidence of gastrointestinal toxicities and attribution to fiber intake
Tidsramme: Up to day +100 post-transplant
|
Point estimates and corresponding 95% confidence intervals will be reported.
Assessed per Common Terminology Criteria for Adverse Events (CTCAE) version (v) 6.
|
Up to day +100 post-transplant
|
|
Frequency and doses of medications for constipation, diarrhea or any other gastrointestinal discomfort
Tidsramme: Up to day +100 post-transplant
|
Point estimates and corresponding 95% confidence intervals will be reported.
|
Up to day +100 post-transplant
|
|
Incidence of systemic toxicities and attribution to fiber intake
Tidsramme: Up to day +100 post-transplant
|
Point estimates and corresponding 95% confidence intervals will be reported.
Assessed per CTCAE v6.
|
Up to day +100 post-transplant
|
|
Incidence of acute grafter versus host disease (GVHD)
Tidsramme: Up to day +100 post-transplant
|
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.
|
Up to day +100 post-transplant
|
|
Involvement of lower gastrointestinal acute GVHD
Tidsramme: Up to day +100 post-transplant
|
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.
|
Up to day +100 post-transplant
|
|
Incidence of severity of infections
Tidsramme: Up to day +100 post-transplant
|
Point estimates and corresponding 95% confidence intervals will be reported.
Will be assessed per Blood and Marrow Transplant Clinical Trials Network criteria.
|
Up to day +100 post-transplant
|
|
Quality of life score
Tidsramme: At day +100 post-transplant
|
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.
|
At day +100 post-transplant
|
|
Incidence of chronic GVHD
Tidsramme: At day +180, 1 year and 2 years post-transplant
|
Point estimates and corresponding 95% confidence intervals will be reported.
Will be estimated using competing-risk methods.
|
At day +180, 1 year and 2 years post-transplant
|
|
Overall survival
Tidsramme: At day +100 and 1 year and 2 years post-transplant
|
Point estimates and corresponding 95% confidence intervals will be reported.
Will be analyzed using Kaplan-Meier methods.
|
At day +100 and 1 year and 2 years post-transplant
|
|
Relapse
Tidsramme: At day +100 and 1 year and 2 years post-transplant
|
Point estimates and corresponding 95% confidence intervals will be reported.
Will be analyzed using cumulative incidence functions.
|
At day +100 and 1 year and 2 years post-transplant
|
|
Non-relapse mortality
Tidsramme: At day +100 and 1 year and 2 years post-transplant
|
Point estimates and corresponding 95% confidence intervals will be reported.
Will be analyzed using cumulative incidence functions.
|
At day +100 and 1 year and 2 years post-transplant
|
Samarbejdspartnere og efterforskere
Sponsor
Sponsor
Samarbejdspartnere
Samarbejdspartnere
Efterforskere
Efterforskere
- Ledende efterforsker: Ryotaro Nakamura, City of Hope Medical Center
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Studiestart
Primær færdiggørelse (Anslået)
Primær færdiggørelse
Studieafslutning (Anslået)
Studieafslutning
Datoer for studieregistrering
Først indsendt
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Først opslået
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering sendt
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- 25887 (Anden identifikator: City of Hope Medical Center)
- P30CA033572 (U.S. NIH-bevilling/kontrakt)
- NCI-2026-03804 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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