Lymphoma, Large B-Cell, DiffuseNCT05327725
Fatigue Reduction Diet in Lymphoma Survivors
A study testing Fatigue Reduction Diet in people with Lymphoma, Large B-Cell, Diffuse and Fatigue, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial summary
The purpose of this small preliminary study is to gather preliminary data to support a large randomized controlled trial of a fatigue reduction diet intervention among diffuse-large B-cell lymphoma (DLBCL) survivors. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Lymphoma, Large B-Cell, Diffuse, Fatigue
- What is being tested?
- Fatigue Reduction Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2021to 24 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (18+) with Diffuse large B-cell lymphoma (DLBCL) who have completed their upfront chemoimmunotherapy, and remained in remission for 2 years prior to enrollment
Who cannot join
- Unable to provide consent or speak English
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
About this study
Official title: Fatigue Reduction Diet in Survivors of Diffuse Large B-Cell Lymphomas; a Preliminary Study
The purpose of this small preliminary study is to gather preliminary data to support a large randomized controlled trial of a fatigue reduction diet intervention among diffuse-large B-cell lymphoma (DLBCL) survivors. This study will provide nutritional counseling to 10 adult patients (18 years or older) with DLBCL who have completed their upfront chemotherapy treatment and remained in remission for 2 years prior to enrollment. The study will employ individualized dietary counseling, provided by a registered dietitian (RD), by phone or video teleconferencing in 8 sessions over 3 months. Dietary intake and fatigue will be assessed at baseline and 3 months. The objective of the study is to determine feasibility of the intervention and adherence to the fatigue reduction diet. Data obtained from this preliminary study would be used to support a well-powered future randomized trial of FRD vs regular diet in survivors of DLBCL.
Read the detailed description
Fatigue is highly prevalent in survivors of diffuse-large B-cell lymphoma (DLBCL). Fatigue has been linked to chronic inflammation, and diets high in antioxidant nutrients (diet rich in fruit, vegetables, whole grains, and omega-3 fatty acid-rich foods) have been associated with lesser prevalence and severity of fatigue. Studies are needed, however, to test if antioxidant-rich diets could improve fatigue in this patient population. This fatigue-reducing diet (FRD) was shown to improve fatigue and sleep in breast cancer survivors compared to regular diet. This FRD diet aligns with the standard of care dietary recommendations for cancer survivors promoted by the American Cancer Society (ACS) . The purpose of this small preliminary study is to gather preliminary data to support a large randomized controlled trial. This study will provide nutritional counseling to 10 adult patients (18 years or older) with DLBCL who have completed their upfront chemotherapy treatment and remained in remission for 2 years prior to enrollment. The study will employ individualized dietary counseling, provided by a registered dietitian (RD), by phone or video teleconferencing. Phone counseling will be weekly for the first month, and then biweekly for the next two months, for a total of 8 phone sessions. Counseling sessions take ~15-30 minutes. Dietary intake will be assessed using an electronic food frequency questionnaire at baseline and 3 months. Fatigue will be assessed using an online survey at baseline and 3 months. The purpose of the study to ascertain the percentage of patients who are able to complete all the study questionnaires and visits and adhere to the fatigue reduction diet. Data obtained from this preliminary study would be used to support a well-powered future randomized trial of FRD vs regular diet in survivors of DLBCL.
- Conditions
- Lymphoma, Large B-Cell, Diffuse, Fatigue
- Being tested
- Fatigue Reduction Diet
- Keywords
- fatigue reduction diet
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fatigue Reduction DietOther
Participants receive individualized nutrition counseling to adopt the fatigue reduction diet protocol.
| Study group | Role | What they receive |
|---|---|---|
| Fatigue Reduction Diet Intervention | Experimental | Participants receive individualized nutrition counseling to adopt the fatigue reduction diet protocol via 8 remote phone or video telehealth sessions with a registered dietitian over 3 months. Receives: Other: Fatigue Reduction Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of intervention
Determine feasibility of recruiting, enrolling and retaining participants in the study, represented as percentage of patients who completed the study.
Measured: 3 months
Adherence to fatigue reduction diet
Determine percentage of patients who adhered to the fatigue reduction diet protocol
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2022
- Study start15 Mar 2021
- Primary completion24 Sep 2021
- Study completion24 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, Large B-Cell, DiffuseStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tonya Orchard, Ohio State University Comprehensive Cancer Center
- Investigators
- Tonya Orchard, PhD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05327725
- Sponsor's protocol ID
- OSU-20182
- Status last verified
- Jul 2024
- First submitted
- 7 Apr 2022
- Last updated
- 4 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 4 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fatigue Reduction Diet in Survivors of Diffuse Large B-Cell Lymphomas; a Preliminary Study
- ClinicalTrials.gov ID
- NCT05327725
- Acronym / sponsor ID
- OSU-20182
- Conditions
- Lymphoma, Large B-Cell, Diffuse, Fatigue
- Keywords
- fatigue reduction diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 24 Sep 2021 (actual)
- Study completion
- 24 Sep 2021 (actual)
- First posted
- 14 Apr 2022 (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.
The purpose of this small preliminary study is to gather preliminary data to support a large randomized controlled trial of a fatigue reduction diet intervention among diffuse-large B-cell lymphoma (DLBCL) survivors. This study will provide nutritional counseling to 10 adult patients (18 years or older) with DLBCL who have completed their upfront chemotherapy treatment and remained in remission for 2 years prior to enrollment. The study will employ individualized dietary counseling, provided by a registered dietitian (RD), by phone or video teleconferencing in 8 sessions over 3 months. Dietary intake and fatigue will be assessed at baseline and 3 months. The objective of the study is to determine feasibility of the intervention and adherence to the fatigue reduction diet. Data obtained from this preliminary study would be used to support a well-powered future randomized trial of FRD vs regular diet in survivors of DLBCL.
Detailed description
Fatigue is highly prevalent in survivors of diffuse-large B-cell lymphoma (DLBCL). Fatigue has been linked to chronic inflammation, and diets high in antioxidant nutrients (diet rich in fruit, vegetables, whole grains, and omega-3 fatty acid-rich foods) have been associated with lesser prevalence and severity of fatigue. Studies are needed, however, to test if antioxidant-rich diets could improve fatigue in this patient population. This fatigue-reducing diet (FRD) was shown to improve fatigue and sleep in breast cancer survivors compared to regular diet. This FRD diet aligns with the standard of care dietary recommendations for cancer survivors promoted by the American Cancer Society (ACS) . The purpose of this small preliminary study is to gather preliminary data to support a large randomized controlled trial. This study will provide nutritional counseling to 10 adult patients (18 years or older) with DLBCL who have completed their upfront chemotherapy treatment and remained in remission for 2 years prior to enrollment. The study will employ individualized dietary counseling, provided by a registered dietitian (RD), by phone or video teleconferencing. Phone counseling will be weekly for the first month, and then biweekly for the next two months, for a total of 8 phone sessions. Counseling sessions take ~15-30 minutes. Dietary intake will be assessed using an electronic food frequency questionnaire at baseline and 3 months. Fatigue will be assessed using an online survey at baseline and 3 months. The purpose of the study to ascertain the percentage of patients who are able to complete all the study questionnaires and visits and adhere to the fatigue reduction diet. Data obtained from this preliminary study would be used to support a well-powered future randomized trial of FRD vs regular diet in survivors of DLBCL.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fatigue Reduction Diet Intervention | Experimental | Other: Fatigue Reduction DietParticipants receive individualized nutrition counseling to adopt the fatigue reduction diet protocol via 8 remote phone or video telehealth sessions with a registered dietitian over 3 months. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients (18+) with Diffuse large B-cell lymphoma (DLBCL) who have completed their upfront chemoimmunotherapy, and remained in remission for 2 years prior to enrollment
Key exclusion criteria (1 listed)
- Unable to provide consent or speak English
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 |
|---|---|---|
| Fatigue Reduction DietParticipants receive individualized nutrition counseling to adopt the fatigue reduction diet protocol. | Other | Fatigue Reduction Diet Intervention |
Primary outcome
Feasibility of intervention
Time frame: 3 months
Determine feasibility of recruiting, enrolling and retaining participants in the study, represented as percentage of patients who completed the study.
Adherence to fatigue reduction diet
Time frame: 3 months
Determine percentage of patients who adhered to the fatigue reduction diet protocol
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2024.
- 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. This study is not recruiting at the moment.
Tonya Orchard, PhD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fatigue Reduction Diet in people with Lymphoma, Large B-Cell, Diffuse and Fatigue, run by Ohio State University Comprehensive 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 4 Sep 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of intervention (time frame: 3 months). 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 4 Sep 2024.