Diet and Exercise Program for Lymphoma Survivors

(LIFE-L Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Craig Moskowitz, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Miami

Disqualifiers: Vegan, Ketogenic, Dementia, Stroke, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

The purpose of this study is to investigate if a mediterranean diet and exercise program for Lymphoma patients during chemotherapy can improve treatment completion and reduce treatment-related side effects.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with your doctor or the trial coordinators.

What data supports the effectiveness of the treatment LIFE-L Home-Based Exercise Program and Mediterranean Diet for Lymphoma Survivors?

Research on breast cancer survivors shows that a lifestyle program combining diet and exercise, similar to the LIFE-L program, improved heart health and quality of life. The Mediterranean diet, a key part of this program, is linked to lower mortality and better health outcomes in cancer survivors. ^{1 2 3 4 5}

Is the Diet and Exercise Program for Lymphoma Survivors safe for humans?

Research on similar diet and exercise programs, like those for breast cancer survivors, shows they are generally safe and can improve health markers like body weight, diet adherence, and fitness levels. These programs have been associated with positive effects on heart and metabolic health, suggesting they are safe for human use. ^{1 6 7 8 9}

How is the Diet and Exercise Program for Lymphoma Survivors different from other treatments?

This treatment is unique because it combines a home-based exercise program with a Mediterranean diet, focusing on lifestyle changes rather than medication. It aims to improve overall health and quality of life for lymphoma survivors by promoting physical activity and healthy eating habits, which have shown benefits in other cancer survivor groups. ^{1 2 3 10 11}

Research Team

Craig Moskowitz, MD

Principal Investigator

University of Miami

Tracy E Crane, PhD, RDN

Principal Investigator

University of Miami

Eligibility Criteria

This trial is for adults over 18 with untreated Non-Hodgkin or Hodgkin lymphoma, starting chemotherapy. Participants must understand English or Spanish, have internet access, and be willing to try a Mediterranean diet and exercise program. They can't already be very active or on special diets like vegan or ketogenic.

Inclusion Criteria

Approval from treating oncologist, confirmed via email or in writing

Able to provide consent

Able to read or understand English or Spanish

Exclusion Criteria

I have not had a stroke, heart attack, or heart failure in the last year.

I am under 18 years old.

Engaging in >150 minutes of moderate to vigorous physical activity on average per week for the prior month

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Chemotherapy

Participants undergo 6 cycles of chemotherapy as per standard of care

Approximately 18 weeks

Weekly visits (in-person)

Lifestyle Intervention

Participants receive weekly phone sessions with a health coach for Mediterranean diet and exercise education

26 weeks

Weekly phone sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (in-person)

Treatment Details

Interventions

• LIFE-L Home-Based Exercise Program (Behavioral Intervention)
• LIFE-L Mediterranean Diet (Behavioral Intervention)
• Supportive Materials (Behavioral Intervention)

Trial Overview The study tests if a Mediterranean diet combined with a home-based exercise program helps Lymphoma patients handle chemo better and reduce side effects. Patients will either start this lifestyle intervention immediately or be placed in a waitlist group to compare outcomes.

Participant Groups

Group I: LIFE-L Group Experimental Treatment 3 Interventions

Participants already undergoing chemotherapy treatment as per standard of care for 6 cycles will meet weekly via phone for 30-45 minutes with a health coach that will provide education on a Mediterranean diet and an exercise program.

Group II: Control Group Experimental Treatment 1 Intervention

Participants in this group already undergoing 6 cycles of chemotherapy will receive study materials and two 30-45 minutes health coaching sessions four weeks post- intervention.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Miami Miami, FL

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Patients Recruited

423,000+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a lifestyle intervention program's on breast cancer survivors' cardiometabolic health: Two-year follow-up. Natalucci, V., Ferri Marini, C., Lucertini, F., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality of Life in Women Diagnosed with Breast Cancer after a 12-Month Treatment of Lifestyle Modifications. Montagnese, C., Porciello, G., Vitale, S., et al.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Role of the Mediterranean Diet in Breast Cancer Survivorship: A Systematic Review and Meta-Analysis of Observational Studies and Randomised Controlled Trials. Chen, G., Leary, S., Niu, J., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Nutrition and physical activity (PA) during and after cancer treatment: Therapeutic benefits, pathophysiology, recommendations, clinical management]. Gouez, M., Raynard, B., Marijnen, P., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The importance of nutrition, diet and lifestyle advice for cancer survivors - the role of nursing staff and interprofessional workers. Murphy, JL., Girot, EA.[2016]

A systematic review of 58 publications identified 34 exercise programs for cancer survivors conducted in home or community settings, highlighting the diversity of interventions available.

The review revealed significant gaps in reporting on the implementation processes and contextual factors affecting these programs, indicating a need for more detailed studies to enhance future community-based exercise interventions for cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community-Based Exercise Programs for Cancer Survivors: A Scoping Review of Program Characteristics Using the Consolidated Framework for Implementation Research. Neil-Sztramko, SE., Smith-Turchyn, J., Fong, A., et al.[2022]

A 6-month dietary intervention for breast cancer survivors significantly improved adherence to a Mediterranean-style diet, with the intervention group increasing their adherence by 22.5% compared to only 2.7% in the control group.

The intervention led to a notable increase in the consumption of anti-inflammatory foods, herbs, and spices, particularly cinnamon, turmeric, and garlic, while also reducing the intake of red meat and sweets, suggesting a positive shift towards healthier eating habits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary intervention among breast cancer survivors increased adherence to a Mediterranean-style, anti-inflammatory dietary pattern: the Rx for Better Breast Health Randomized Controlled Trial. Zuniga, KE., Parma, DL., Muñoz, E., et al.[2020]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a Home-Based Lifestyle Intervention Program on Cardiometabolic Health in Breast Cancer Survivors during the COVID-19 Lockdown. Natalucci, V., Marini, CF., Flori, M., et al.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation of the German version of the Mediterranean Diet Adherence Screener (MEDAS) questionnaire. Hebestreit, K., Yahiaoui-Doktor, M., Engel, C., et al.[2019]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise in adult and pediatric hematological cancer survivors: an intervention review. Wolin, KY., Ruiz, JR., Tuchman, H., et al.[2013]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Nutrition prevention intervention for cancers: "Med-Food Anticancer Program"]. Panunzio, MF., Caporizzi, R., Antoniciello, A., et al.[2012]

References

1. England pubmed.ncbi.nlm.nih.gov

Effect of a lifestyle intervention program's on breast cancer survivors' cardiometabolic health: Two-year follow-up. [2023]

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

Quality of Life in Women Diagnosed with Breast Cancer after a 12-Month Treatment of Lifestyle Modifications. [2021]

3. Switzerland pubmed.ncbi.nlm.nih.gov

The Role of the Mediterranean Diet in Breast Cancer Survivorship: A Systematic Review and Meta-Analysis of Observational Studies and Randomised Controlled Trials. [2023]

4. France pubmed.ncbi.nlm.nih.gov

[Nutrition and physical activity (PA) during and after cancer treatment: Therapeutic benefits, pathophysiology, recommendations, clinical management]. [2022]

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

The importance of nutrition, diet and lifestyle advice for cancer survivors - the role of nursing staff and interprofessional workers. [2016]

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

Community-Based Exercise Programs for Cancer Survivors: A Scoping Review of Program Characteristics Using the Consolidated Framework for Implementation Research. [2022]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Dietary intervention among breast cancer survivors increased adherence to a Mediterranean-style, anti-inflammatory dietary pattern: the Rx for Better Breast Health Randomized Controlled Trial. [2020]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Effects of a Home-Based Lifestyle Intervention Program on Cardiometabolic Health in Breast Cancer Survivors during the COVID-19 Lockdown. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Validation of the German version of the Mediterranean Diet Adherence Screener (MEDAS) questionnaire. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Exercise in adult and pediatric hematological cancer survivors: an intervention review. [2013]

11. Italy pubmed.ncbi.nlm.nih.gov

[Nutrition prevention intervention for cancers: "Med-Food Anticancer Program"]. [2012]