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Behavioural Intervention

Fatigue Reduction Diet- FRD for Lymphoma

N/A

Recruiting

Led By Suzie Zick

Research Sponsored by University of Michigan Rogel Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of DLBCL treated with R-CHOP or R-EPOCH

Have an average persistent fatigue defined as ≥ 4 on the Brief Fatigue Inventory

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months after enrollment

Awards & highlights

Study Summary

This trial will evaluate the effects of individualized counseling on fatigue, quality of life, and symptoms in lymphoma cancer survivors who are experiencing persistent fatigue. The counseling will be delivered by registered dietitians

Who is the study for?

This trial is for men and women over 18 who finished their primary lymphoma treatments between 6 months to 2 years ago, have no signs of disease getting worse, eat less than 5.5 servings of fruits and veggies a day, were treated with specific chemo regimens (R-CHOP or R-EPOCH), suffer from persistent fatigue since their diagnosis, and can use email for study questionnaires.Check my eligibility

What is being tested?

The study tests if personalized dietitian counseling on a Fatigue Reduction Diet (FRD) via phone/video calls helps reduce tiredness and improves life quality in fatigued lymphoma survivors compared to general health advice. Participants are randomly chosen to receive either the FRD or General Health Curriculum over three months.See study design

What are the potential side effects?

Since this trial involves dietary counseling rather than medication, side effects may be minimal but could include potential dietary changes discomforts such as digestive adjustments when altering eating habits.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have DLBCL and was treated with R-CHOP or R-EPOCH.

Select...

I often feel very tired, scoring 4 or more on a fatigue scale.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months after enrollment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months after enrollment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months after enrollment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Brief Fatigue Inventory

Secondary outcome measures

Examining the acceptability of the FRD program- FRD initiation

Examining the effect of 3 months of FRD compared to an attention control GHC on Quality of life

Examining the effect of 3 months of FRD compared to an attention control GHC on adherence to program

+5 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Fatigue Reduction Diet- FRDExperimental Treatment1 Intervention

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

Group II: General Health Curriculum- GHCActive Control1 Intervention

3 months of individualized counseling of the attention control (matched for time and frequency of interactions with the FRD) the General Health Curriculum (GHC)

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

American Institute for Cancer ResearchOTHER

10 Previous Clinical Trials

8,493 Total Patients Enrolled

University of Michigan Rogel Cancer CenterLead Sponsor

294 Previous Clinical Trials

24,193 Total Patients Enrolled

21 Trials studying Lymphoma

475 Patients Enrolled for Lymphoma

Suzie ZickPrincipal InvestigatorUniversity of Michigan Rogel Cancer Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are researchers currently recruiting participants for this ongoing clinical trial?

"Indeed, clinicaltrials.gov data confirms that this investigation is actively seeking suitable candidates. The trial was initially published on January 1st, 2024 and last revised on January 23rd, 2024. Researchers aim to recruit a total of 68 participants from one designated location."

Answered by AI

What is the current number of individuals being admitted into this clinical study?

"Indeed, the details on clinicaltrials.gov affirm that this study is presently enrolling participants. The initial posting for this trial was made on January 1st, 2024 and it underwent its most recent revision on January 23rd, 2024. Recruitment aims to include a total of 68 patients from one designated site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Living Well With Lymphoma

2024. "Living Well With Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06047626.