LymphomaNCT06047626
Living Well With Lymphoma
A study testing Fatigue Reduction Diet and General Health Curriculum in people with Lymphoma, run by University of Michigan Rogel Cancer Center at 1 site in United States.
Trial summary
In this study the investigators are proposing to evaluate the efficacy, sustainability, and mechanisms of 3 months of individualized counseling of the FRD delivered by registered dietitians, over 8 sessions by phone/video conferencing on fatigue, quality of life, and associated symptoms in persistently fatigued… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma
- What is being tested?
- Fatigue Reduction Diet and General Health Curriculum
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Mar 2024to Sep 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
- Women and men aged 18 years and older
- Diagnosis of lymphoma (Hodgkin and non-Hodgkin)
- Have an average persistent fatigue defined as ≥ 4 on the Brief Fatigue Inventory
- Fatigue must be attributed to lymphoma diagnosis
- Fatigue onset must be between 12months before diagnosis and any time after diagnosis
- Fatigue must not be attributed to other disease diagnoses
- Fruit and vegetable intake ≤5.5 servings/day
- Have, or be willing to create, an email address to receive study questionnaires electronically.
Who cannot join
- Medically unstable
- BMI<18.5 kg/m2
- Have a current untreated diagnosis of mood disorder, e.g., bipolar or major depressive disorder
- Have a current untreated diagnosis of anemia
- Have a current untreated diagnosis of hypothyroidism
- Have an initiation, a cessation or change of treatment of any chronic medications, dietary supplements, behavioral therapy, physical therapy etc., or any planned change of medications, supplements, or therapies during the study
- Have a current diagnoses of cachexia
- Planning on becoming pregnant, currently pregnant or lactating
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
University of Michigan
Ann Arbor, Michigan, 48109
Sara Snyder, 734-998-7124, fammed-szickstudy@med.umich.edu
Suzie Zick
About this study
Official title: Living Well With Lymphoma: Improving Diet Quality to Improve Energy, Sleep and Quality of Life
In this study the investigators are proposing to evaluate the efficacy, sustainability, and mechanisms of 3 months of individualized counseling of the FRD delivered by registered dietitians, over 8 sessions by phone/video conferencing on fatigue, quality of life, and associated symptoms in persistently fatigued lymphoma cancer survivors compared to 3 months of individualized counseling of the attention control (matched for time and frequency of interactions with the FRD) the General Health Curriculum (GHC). The investigators will randomize and follow 68 lymphoma cancer survivors; accounting for a ~10% drop out rate to achieve a target of 60 patients that will complete the study. The investigators hypothesize that persistently fatigued lymphoma cancer survivors will experience improvements in fatigue, quality of life, and symptoms commonly associated with fatigue, which are then maintained at 15-months post-enrollment; and decreased CRP and alterations in inflammation-associated DNA methylation consistent with reduced inflammation from following the FRD as compared to the GHC.
Read the detailed description
26OCT2025- Overall enrollment increased to 100
- Conditions
- Lymphoma
- Being tested
- Fatigue Reduction Diet, General Health Curriculum
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fatigue Reduction DietOther
Sessions will be ~15 minutes for 8 sessions. The FRD maintains participants on a diet with their typical caloric intake as assessed at baseline, and replaces some of their calories with the following foods on a daily basis: at least 50% of servings grains to be whole grains (these would replace non-whole grain foods); 5 servings of vegetables (1 leafy green, 1 tomato, and 1 yellow/orange); 2 servings of fruit (1 high in vitamin C), both fruit and vegetables would replace some of the carbohydrates from non-fruit and vegetable sources; 1 serving of fatty fish and or 1 serving of nuts and/or seeds (2 servings of nuts and/or seeds for vegetarians), both the fish, the nuts, and seeds will replace existing sources of fats and proteins in the diet.
General Health CurriculumOther
These sessions will be matched counseling method, time spent (~15 minutes per session), for 8 sessions. Registered Dietitians will discuss general health topics with the participant, excluding topics of diet and food.
| Study group | Role | What they receive |
|---|---|---|
| Fatigue Reduction Diet- FRD | Experimental | 3 months of individualized counseling of the FRD delivered by registered dietitians, over 8 sessions by phone/video conferencing on fatigue, quality of life, and associated symptoms in persistently fatigued lymphoma cancer survivors Receives: Other: Fatigue Reduction Diet |
| General Health Curriculum- GHC | Active comparator | 3 months of individualized counseling of the attention control (matched for time and frequency of interactions with the FRD) the General Health Curriculum (GHC) Receives: Other: General Health Curriculum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brief Fatigue Inventory
To examine the effect of 3 months of FRD compared to an attention control GHC on persistent fatigue, measured with the Brief Fatigue Inventory. The instrument consists of 9 items, each measuring fatigue on a 0-10 scale, and is calculated from the mean of completed items
Measured: 3 months after enrollment
Secondary outcomes (8)
Examining the effect of 3 months of FRD compared to an attention control GHC on Quality of life
Quality of life, using the Functional Assessment of Chronic Illness Therapy Measurement System, specifically the lymphoma cancer specific instrument. The total score will be our primary outcome. The FACT-G has demonstrated reliability, validity, and responsiveness to change over time.
Measured: 3 months after enrollment
The effect of 3 months of FRD compared to an attention control GHC on persistent sleep disturbance
Using the PROMIS SF v1.0- Sleep Disturb 8b survey
Measured: 3 months after enrollment
The effect of 3 months of FRD compared to an attention control GHC on persistent pain
Using the PROMIS SF v1.1- Pain Interference 8a survey
Measured: 3 months after enrollment
The effect of 3 months of FRD compared to an attention control GHC on persistent mood
Using the PROMIS SF v1.0 Anxiety 7a and Depression 8b surveys
Measured: 3 months after enrollment
The effect of 3 months of FRD compared to an attention control GHC on persistent sexual function
Using the PROMIS Sexual Function Profile v1.0 Mal and Female surveys
Measured: 3 months after enrollment
Examining the effect of 3 months of FRD compared to an attention control GHC on adherence to program
Adherence measured with a food frequency questionnaire (FFQ) and food checklists.
Measured: 3 months after enrollment
Examining the acceptability of the FRD program- FRD initiation
Acceptability via semi-structured interviews (only in the FRD arm), specifically barriers and facilitators to FRD initiation
Measured: 3 months after enrollment
Number of subjects who withdraw from study (acceptability)
Acceptability via withdrawals over the 3-month intervention phase
Measured: 3 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start7 Mar 2024
- Primary completionSep 2027 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by University of Michigan Rogel 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
- University of Michigan Rogel Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- American Institute for Cancer Research
- Responsible party
- Sponsor
- Investigators
- Suzie Zick, Principal investigator, University of Michigan Rogel Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06047626
- Sponsor's protocol ID
- UMCC 2023.015
- Other IDs
- HUM00230256
- Status last verified
- Nov 2026
- First submitted
- 3 Apr 2023
- Last updated
- 9 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No we would not make individual data just composite data available.
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Living Well With Lymphoma: Improving Diet Quality to Improve Energy, Sleep and Quality of Life
- ClinicalTrials.gov ID
- NCT06047626
- Acronym / sponsor ID
- UMCC 2023.015
- Conditions
- Lymphoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Michigan Rogel Cancer CenterUniversity, hospital or other
- Collaborators
- American Institute for Cancer Research
- Study start
- 7 Mar 2024 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 21 Sep 2023 (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.
In this study the investigators are proposing to evaluate the efficacy, sustainability, and mechanisms of 3 months of individualized counseling of the FRD delivered by registered dietitians, over 8 sessions by phone/video conferencing on fatigue, quality of life, and associated symptoms in persistently fatigued lymphoma cancer survivors compared to 3 months of individualized counseling of the attention control (matched for time and frequency of interactions with the FRD) the General Health Curriculum (GHC). The investigators will randomize and follow 68 lymphoma cancer survivors; accounting for a ~10% drop out rate to achieve a target of 60 patients that will complete the study. The investigators hypothesize that persistently fatigued lymphoma cancer survivors will experience improvements in fatigue, quality of life, and symptoms commonly associated with fatigue, which are then maintained at 15-months post-enrollment; and decreased CRP and alterations in inflammation-associated DNA methylation consistent with reduced inflammation from following the FRD as compared to the GHC.
Detailed description
26OCT2025- Overall enrollment increased to 100
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fatigue Reduction Diet- FRD | Experimental | Other: Fatigue Reduction Diet3 months of individualized counseling of the FRD delivered by registered dietitians, over 8 sessions by phone/video conferencing on fatigue, quality of life, and associated symptoms in persistently fatigued lymphoma cancer survivors |
| General Health Curriculum- GHC | Active comparator | Other: General Health Curriculum3 months of individualized counseling of the attention control (matched for time and frequency of interactions with the FRD) the General Health Curriculum (GHC) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Women and men aged 18 years and older
- Diagnosis of lymphoma (Hodgkin and non-Hodgkin)
- Have an average persistent fatigue defined as ≥ 4 on the Brief Fatigue Inventory
- Fatigue must be attributed to lymphoma diagnosis
- Fatigue onset must be between 12months before diagnosis and any time after diagnosis
Key exclusion criteria (8 listed)
- Medically unstable
- BMI<18.5 kg/m2
- Have a current untreated diagnosis of mood disorder, e.g., bipolar or major depressive disorder
- Have a current untreated diagnosis of anemia
- Have a current untreated diagnosis of hypothyroidism
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 DietSessions will be ~15 minutes for 8 sessions. The FRD maintains participants on a diet with their typical caloric intake as assessed at baseline, and replaces some of their calories with the following foods on a daily basis: at least 50% of servings grains to be whole grains (these would replace non-whole grain foods); 5 servings of vegetables (1 leafy green, 1 tomato, and 1 yellow/orange); 2 servings of fruit (1 high in vitamin C), both fruit and vegetables would replace some of the carbohydrates from non-fruit and vegetable sources; 1 serving of fatty fish and or 1 serving of nuts and/or seeds (2 servings of nuts and/or seeds for vegetarians), both the fish, the nuts, and seeds will replace existing sources of fats and proteins in the diet. | Other | Fatigue Reduction Diet- FRD |
| General Health CurriculumThese sessions will be matched counseling method, time spent (~15 minutes per session), for 8 sessions. Registered Dietitians will discuss general health topics with the participant, excluding topics of diet and food. | Other | General Health Curriculum- GHC |
Primary outcome
Brief Fatigue Inventory
Time frame: 3 months after enrollment
To examine the effect of 3 months of FRD compared to an attention control GHC on persistent fatigue, measured with the Brief Fatigue Inventory. The instrument consists of 9 items, each measuring fatigue on a 0-10 scale, and is calculated from the mean of completed items
8 secondary outcomes
Examining the effect of 3 months of FRD compared to an attention control GHC on Quality of life
Time frame: 3 months after enrollment
The effect of 3 months of FRD compared to an attention control GHC on persistent sleep disturbance
Time frame: 3 months after enrollment
The effect of 3 months of FRD compared to an attention control GHC on persistent pain
Time frame: 3 months after enrollment
The effect of 3 months of FRD compared to an attention control GHC on persistent mood
Time frame: 3 months after enrollment
The effect of 3 months of FRD compared to an attention control GHC on persistent sexual function
Time frame: 3 months after enrollment
Examining the effect of 3 months of FRD compared to an attention control GHC on adherence to program
Time frame: 3 months after enrollment
Examining the acceptability of the FRD program- FRD initiation
Time frame: 3 months after enrollment
Number of subjects who withdraw from study (acceptability)
Time frame: 3 months after enrollment
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 9 Nov 2026.
- Individual participant dataSharing planned: No. No we would not make individual data just composite data available.
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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.
Suzie Zick principal investigator
University of Michigan Rogel Cancer 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 Fatigue Reduction Diet and General Health Curriculum in people with Lymphoma, run by University of Michigan Rogel 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 8 inclusion and 8 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 9 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 Sara Snyder (734-998-7124, fammed-szickstudy@med.umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brief Fatigue Inventory (time frame: 3 months after enrollment). 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 9 Nov 2026.