Fatigue Reduction Diet for Lymphoma Survivors

Overseen by Suzie Zick

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Michigan Rogel Cancer Center

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

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the Fatigue Reduction Diet treatment for reducing fatigue in lymphoma survivors?

A pilot study showed that the Fatigue Reduction Diet (FRD) improved diet quality and significantly reduced fatigue in lymphoma survivors over a 12-week period. Participants who followed the diet, which included specific fruits, vegetables, whole grains, and omega-3 rich foods, reported less fatigue by the end of the study. ^{1 2 3 4 5}

Is the Fatigue Reduction Diet safe for humans?

The Fatigue Reduction Diet (FRD) has been tested in a pilot study with lymphoma survivors and was found to be feasible and acceptable, with participants attending all sessions and completing the intervention without reported safety issues. Additionally, similar dietary interventions aimed at reducing cancer-related fatigue have been well-tolerated by cancer survivors, suggesting that such diets are generally safe for humans. ^{1 2 3 5 6}

How does the Fatigue Reduction Diet treatment differ from other treatments for lymphoma survivors?

The Fatigue Reduction Diet (FRD) is unique because it focuses on improving diet quality through specific food choices like fruits, vegetables, whole grains, and omega-3 rich foods, which are believed to reduce cancer-related fatigue by addressing nutritional deficiencies and inflammation. Unlike other treatments, FRD is a remote dietary intervention involving personalized sessions with a dietitian, making it accessible and tailored to individual needs. ^{1 2 3 5 7}

Research Team

Suzie Zick

Principal Investigator

University of Michigan Rogel Cancer Center

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Fatigue Reduction Diet (Behavioural Intervention)
• General Health Curriculum (Behavioural Intervention)

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.

Participant Groups

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+

Marschall S. Runge

University of Michigan Rogel Cancer Center

Chief Executive Officer since 2015

MD, PhD

Eric R. Fearon

University of Michigan Rogel Cancer Center

Chief Medical Officer since 2016

MD, PhD

American Institute for Cancer Research

Collaborator

Trials

12

Recruited

8,600+

Findings from Research

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]

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]

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 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]

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]

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]

References

1. United States 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. [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Cooking for Vitality: Pilot Study of an Innovative Culinary Nutrition Intervention for Cancer-Related Fatigue in Cancer Survivors. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Nutritional Interventions for Treating Cancer-Related Fatigue: A Qualitative Review. [2020]

4. England 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. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Diet components associated with perceived fatigue in breast cancer survivors. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Dietary Composition, Meal Timing, and Cancer-Related Fatigue: Insights From the Women's Healthy Eating and Living Study. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Fatigue, inflammation, and ω-3 and ω-6 fatty acid intake among breast cancer survivors. [2022]