Fatigue Reduction Diet for Lymphoma Survivors

Overseen By Sara Snyder

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan Rogel Cancer Center

Disqualifiers: Mood disorders, Anemia, Hypothyroidism, Cachexia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 12 weeks

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a special Fatigue Reduction Diet can reduce fatigue and improve the quality of life for lymphoma survivors. Participants will receive personalized diet advice from registered dietitians via phone or video calls for three months. The study will compare this diet to a general health course to assess effectiveness. Suitable candidates are those experiencing persistent fatigue due to lymphoma and consuming fewer than 5.5 servings of fruits and vegetables daily. As an unphased trial, it provides a unique opportunity to explore personalized dietary strategies to enhance well-being.

Will I have to stop taking my current medications?

The trial requires that you do not change your current medications, supplements, or therapies during the study. If you have recently started, stopped, or changed any chronic medications, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the Fatigue Reduction Diet (FRD) is safe for people. An earlier study found that participants not only found the FRD easy to follow and enjoyable, but it also appeared to improve diet quality and reduce tiredness in lymphoma survivors. Participants reported feeling significantly less tired and experiencing less overall disability. This indicates that the diet is manageable and does not cause harmful side effects. Therefore, the evidence supports the safety of the FRD for those considering joining the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Fatigue Reduction Diet (FRD) is unique because it offers a personalized nutritional approach to combat fatigue in lymphoma survivors, unlike standard treatments that mainly focus on medication and physical therapy. Researchers are excited about this diet because it involves individualized counseling from registered dietitians, providing tailored advice over the course of eight sessions via phone or video. This method aims to improve not only fatigue but also overall quality of life and associated symptoms, offering a holistic and accessible alternative to traditional treatment.

What evidence suggests that the Fatigue Reduction Diet could be effective for reducing fatigue in lymphoma survivors?

Research has shown that the Fatigue Reduction Diet (FRD), which participants in this trial may receive, can help lymphoma survivors experiencing ongoing tiredness. In earlier studies, individuals who followed the FRD felt significantly less tired and reported an improved quality of life. The diet not only reduced their fatigue but also increased their confidence in managing it. Additionally, participants found the FRD easy to follow. This suggests that dietary changes can be a powerful way to manage fatigue for lymphoma survivors. ^{1 4 6 7 8}

Who Is on the Research Team?

Suzie Zick

Principal Investigator

University of Michigan Rogel Cancer Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

You consume no more than 5.5 servings of fruit and vegetables per day.

You possess, or are willing to establish, an email address for the purpose of receiving research surveys electronically.

My fatigue began after being diagnosed with DLBCL.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

3 months of individualized counseling of the Fatigue Reduction Diet (FRD) or General Health Curriculum (GHC) delivered by registered dietitians over 8 sessions by phone/video conferencing

12 weeks

8 sessions (phone/video conferencing)

Follow-up

Participants are monitored for improvements in fatigue, quality of life, and associated symptoms, maintained at 15-months post-enrollment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Fatigue Reduction Diet
• General Health Curriculum

Trial Overview

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.

How Is the Trial Designed?

Group I: Fatigue Reduction Diet- FRD Experimental Treatment 1 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- GHC Active Control 1 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)

Who Is Running the Clinical Trial?

University of Michigan Rogel Cancer Center

Lead Sponsor

Trials

303

Recruited

20,700+

American Institute for Cancer Research

Collaborator

Trials

12

Recruited

8,600+

Published Research Related to This Trial

The Cooking for Vitality (C4V) intervention, a culinary nutrition program for cancer survivors, showed high feasibility and acceptability, with 70% recruitment and 72% retention rates, indicating it can be effectively implemented for patients experiencing cancer-related fatigue (CRF).

Participants experienced significant improvements in fatigue levels, overall disability, and confidence in managing fatigue after the intervention, suggesting that dietary education and cooking skills can positively impact quality of life for cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cooking for Vitality: Pilot Study of an Innovative Culinary Nutrition Intervention for Cancer-Related Fatigue in Cancer Survivors. Pritlove, C., Capone, G., Kita, H., et al.[2021]

Cancer-related fatigue (CRF) can persist for years in cancer survivors, and nutritional interventions may help alleviate this fatigue by addressing inflammation and improving body composition.

Dietary patterns like the Mediterranean diet, increased protein intake, and supplements such as ginseng and probiotics have shown potential in reducing fatigue and improving energy levels in cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutritional Interventions for Treating Cancer-Related Fatigue: A Qualitative Review. Inglis, JE., Lin, PJ., Kerns, SL., et al.[2020]

A 12-week remote Fatigue Reduction Diet (FRD) intervention for diffuse large B-cell lymphoma (DLBCL) survivors was feasible and well-accepted, with 90% of participants attending all sessions.

Participants showed significant improvements in diet quality and a reduction in cancer-related fatigue, indicating that dietary interventions may be effective in enhancing the quality of life for lymphoma survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A remote Whole Food Dietary Intervention to Reduce Fatigue and Improve Diet Quality in Lymphoma Survivors: Results of a Feasibility Pilot Study. Weinhold, KR., Light, S., Bittoni, AM., et al.[2023]

In a study of 2914 early-stage breast cancer survivors, better dietary quality and earlier eating times were linked to reduced fatigue and increased energy levels.

Although the dietary intervention did not show an overall improvement in fatigue, it was more effective for younger participants with fewer health issues, suggesting that personalized dietary approaches may be beneficial for managing cancer-related fatigue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary Composition, Meal Timing, and Cancer-Related Fatigue: Insights From the Women's Healthy Eating and Living Study. Kleckner, AS., Kleckner, IR., Renn, CL., et al.[2023]

A systematic review of 29 randomized controlled trials found that 17 were effective in reducing cancer-related fatigue among survivors, with key behavior change techniques (BCTs) like goal setting and instruction on how to perform behaviors being frequently used.

The BCT 'Generalisation of the target behaviour' was identified as promising for helping cancer survivors incorporate lifestyle changes into their daily lives, but there is a need for more studies focusing on dietary behaviors and including follow-up assessments to evaluate long-term effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behaviour change techniques used in lifestyle interventions that aim to reduce cancer-related fatigue in cancer survivors: a systematic review. de Vries-Ten Have, J., Winkels, RM., Kampman, E., et al.[2023]

In a study of 633 breast cancer survivors, higher levels of inflammation (measured by C-reactive protein) were associated with increased fatigue, indicating that inflammation may contribute to fatigue in these individuals.

The research found that a higher intake of ω-6 polyunsaturated fatty acids (PUFAs) relative to ω-3 PUFAs was linked to greater inflammation and fatigue, suggesting that increasing ω-3 PUFA intake could potentially help reduce fatigue in breast cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fatigue, inflammation, and ω-3 and ω-6 fatty acid intake among breast cancer survivors. Alfano, CM., Imayama, I., Neuhouser, ML., et al.[2022]

In a study of 42 breast cancer survivors, higher fat intake was linked to increased fatigue, while higher fiber and carbohydrate intake were associated with reduced fatigue levels.

Participants consuming less than 25 grams of fiber per day reported significantly higher fatigue compared to those consuming more, suggesting that a diet rich in fiber and low in fat may help alleviate fatigue in breast cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diet components associated with perceived fatigue in breast cancer survivors. Guest, DD., Evans, EM., Rogers, LQ.[2021]

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The 12-week remote FRD intervention was feasible, acceptable, and holds promise to improve diet quality and fatigue in DLBCL survivors.

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The preliminary findings suggest that the FRD intervention may be an effective approach to improve diet quality among older lymphoma survivors. Further ...

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Fatigue Reduction Diet for Lymphoma Survivors

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For five of seven participants the total level of fatigue was reduced, and for six out of seven participants, the global HRQoL score improved.

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