Plant-Based Meals for Multiple Myeloma

Overseen By Kate Markey

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Fred Hutchinson Cancer Center

Disqualifiers: Major psychiatric diagnosis, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the impact of a plant-based meal delivery service on gut health for people with multiple myeloma, a type of blood cancer. Participants will undergo a procedure where their own blood-forming stem cells are removed and then returned to their body to help fight the cancer. Researchers aim to determine if plant-based meals can improve gut health during this process. The trial suits those planning their first stem cell transplant for multiple myeloma and who can manage meals at home. As an unphased trial, it offers a unique opportunity to contribute to research that could enhance the quality of life for multiple myeloma patients.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on diet changes, so you may not need to stop your medications, but it's best to check with the trial organizers.

What prior data suggests that this plant-based whole-foods meal delivery service is safe for patients with multiple myeloma?

Research has shown that plant-based diets are generally safe and may offer health benefits. One study found that a healthy plant-based diet could lower the risk of developing multiple myeloma, partly due to higher fiber content. Other research suggests that plant-based meals can improve gut health, which is important for those receiving treatments like stem cell transplants.

Overall, no major safety issues have been reported with plant-based diets. Most people tolerate these meals well, and they can enhance overall well-being. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using a plant-based whole-foods meal delivery service for multiple myeloma because it offers a novel, non-invasive approach to supportive care. Unlike traditional treatments for multiple myeloma, which often include chemotherapy, immunotherapy, or stem cell transplants, this approach focuses on nutrition to potentially improve patient well-being and quality of life. By providing three nutritious meals and snacks per day, along with weekly consultations with a dietitian, this treatment aims to support patients' overall health and possibly enhance their response to other therapies. This nutritional strategy could offer a complementary way to manage symptoms and improve health outcomes for people with multiple myeloma.

What evidence suggests that a plant-based whole-foods meal delivery service is effective for improving microbial health in multiple myeloma patients?

Research has shown that a plant-based diet might benefit people with multiple myeloma by improving gut health. In this trial, participants will receive a Plant-Based Whole-Foods Meal Delivery Service as part of the supportive care arm. Studies have found that individuals who consume more plant-based foods, such as fruits, vegetables, and whole grains, have a lower risk of developing multiple myeloma. This diet can increase the variety of beneficial gut bacteria. A diverse range of gut bacteria is linked to better health for patients undergoing treatments like stem cell transplants. Early findings suggest that a plant-based diet might help manage multiple myeloma by promoting a healthier gut. ^{1 2 4 6 7}

Who Is on the Research Team?

Kate Markey

Principal Investigator

Fred Hutch/University of Washington Cancer Consortium

Are You a Good Fit for This Trial?

This trial is for patients with multiple myeloma who are undergoing an autologous hematopoietic cell transplant. The study aims to see if a plant-based whole-foods meal delivery can improve their gut microbiome, which is important for health during the transplant process.

Inclusion Criteria

I am scheduled for my first stem cell transplant for multiple myeloma.

I can reheat food by myself.

Able to consume an oral diet at enrollment

Exclusion Criteria

Major psychiatric diagnosis that impairs cognitive functioning or is not controlled at the time of the approach, as judged by the patient's medical team

I am scheduled for an inpatient transplant procedure.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Peri-transplant

Participants receive 3 meals per day and snacks delivered twice weekly and meet with dietitian once weekly on days -7 to 28. Blood and stool samples are collected.

5 weeks

Twice weekly meal delivery, weekly dietitian meetings

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of meal tolerability and collection rates.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Plant-Based Whole-Foods Meal Delivery Service

Trial Overview The intervention being tested is a plant-based whole-foods meal delivery service designed to enhance microbial diversity in the gut. This will be evaluated through medical chart reviews, biospecimen collection to analyze microbiome changes, and questionnaires about dietary intake.

How Is the Trial Designed?

Group I: Supportive care (meal delivery service) Experimental Treatment 4 Interventions

Patients receive 3 meals per day and snacks delivered twice weekly and meet with dietitian once weekly on days -7 to 28. Patients undergo blood and stool sample collection on study.

Who Is Running the Clinical Trial?

Fred Hutchinson Cancer Center

Lead Sponsor

Trials

583

Recruited

1,341,000+

Swim Across America

Collaborator

Trials

8

Recruited

290+

Swim Across America

Collaborator

Trials

11

Recruited

410+

Published Research Related to This Trial

Plant-based and plant-forward diets, such as the Mediterranean diet, may offer protective benefits against common men's health issues like prostate cancer, erectile dysfunction, and benign prostatic hyperplasia, based on a systematic review of 24 studies.

While the evidence is not yet robust, the literature indicates a consistent small beneficial impact of these diets on men's health conditions, alongside their known advantages for other chronic health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Should Men Eat More Plants? A Systematic Review of the Literature on the Effect of Plant-Forward Diets on Men's Health. Feiertag, N., Tawfik, MM., Loloi, J., et al.[2023]

Vegetarian diets may lower the risk of prostate cancer, but the specific role of dietary fiber is unclear due to the antioxidant properties of plant foods.

A proposed nutritional approach, including a diet with low fat, high fiber, and 40 g of soybean protein daily, is being studied as a potential strategy for managing prostate cancer, although more rigorous large-scale studies are needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Cancer of the prostate: influence of nutritional factors. A new nutritional approach]. de la Taille, A., Katz, A., Vacherot, F., et al.[2017]

A pilot clinical trial showed that patients with recurrent prostate cancer could successfully adopt and maintain a plant-based diet over 6 months, significantly increasing their intake of whole grains and vegetables.

The study found a decrease in the rate of PSA rise, an indicator of disease progression, during the first 3 months of dietary intervention, suggesting that a plant-based diet may have therapeutic potential in managing prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adoption of a plant-based diet by patients with recurrent prostate cancer. Nguyen, JY., Major, JM., Knott, CJ., et al.[2016]

Oncology nurses play a crucial role in ensuring that cancer patients meet their nutritional needs, which can significantly impact their quality of life during and after treatment.

Promoting a healthful plant-based diet, along with weight management, is essential for cancer survivors, who now make up about 4% of the US population, emphasizing the importance of nutrition in long-term health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutrition during and after cancer therapy. Barrera, S., Demark-Wahnefried, W.[2021]

In a 20-week trial involving 40 participants with type 2 diabetes, both a low-fat vegan eating plan and a portion-controlled eating plan led to significant improvements in body weight, hemoglobin A1c (HbA1c), and LDL cholesterol levels, indicating effective dietary interventions for diabetes management.

Despite the improvements in metabolic markers, there were no significant differences between the two eating plans, suggesting that both approaches can be beneficial for individuals with type 2 diabetes when integrated into a clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Turning the Waiting Room into a Classroom: Weekly Classes Using a Vegan or a Portion-Controlled Eating Plan Improve Diabetes Control in a Randomized Translational Study. Barnard, ND., Levin, SM., Gloede, L., et al.[2022]

In the NIH-AARP Diet and Health study, which included 392,589 participants and identified 1,366 cases of multiple myeloma (MM), a healthful plant-based diet was associated with a reduced risk of developing MM, suggesting dietary choices may influence cancer risk.

While the association between a healthful plant-based diet and reduced MM risk was significant, it became less clear in sensitivity analyses, indicating that further research is needed to confirm these findings, especially since MM is a rare disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pre-Diagnosis Dietary Patterns and Risk of Multiple Myeloma in the NIH-AARP Diet and Health Study. Castro, F., Parikh, R., Eustaquio, JC., et al.[2023]

A healthy plant-based diet (hPDI) is associated with a reduced risk of total digestive system cancers, with significant reductions observed for gastrointestinal tract and liver cancers, based on data from three large cohorts totaling over 4.9 million person-years.

Conversely, an unhealthful plant-based diet (uPDI) is linked to an increased risk of gastrointestinal and colorectal cancers, highlighting the importance of diet quality in cancer prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Plant-based dietary patterns and the risk of digestive system cancers in 3 large prospective cohort studies. Kim, J., Khil, J., Kim, H., et al.[2023]

In a study of 36,825 adults over an average of 8.3 years, higher quality plant-based foods were linked to a significantly lower risk of all-cause mortality, with a hazard ratio of 0.66 for those in the highest quartile of plant-based diet quality.

No significant association was found between the quality of animal-based foods and mortality, suggesting that focusing on healthy plant-based foods may be more beneficial for longevity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Plant- and animal-based diet quality and mortality among US adults: a cohort study. Keaver, L., Ruan, M., Chen, F., et al.[2021]

The 8-week 'Coping with Cancer in the Kitchen' (CCK) program significantly improved cancer survivors' knowledge, confidence, and skills in adopting a plant-based diet compared to receiving printed materials, with 54 participants involved in the study.

Participants in the CCK program showed a notable reduction in processed meat intake and decreased perceived barriers to eating more fruits and vegetables, suggesting that in-person education can effectively promote healthier dietary choices among cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Controlled Trial Testing the Effectiveness of Coping with Cancer in the Kitchen, a Nutrition Education Program for Cancer Survivors. Miller, MF., Li, Z., Habedank, M.[2021]

Whole food plant-based diets, including vegan and vegetarian options, are nutritionally sufficient and can provide health benefits, but poorly designed versions may lead to significant nutritional deficiencies.

Healthcare practitioners should assess patients on plant-based diets by considering seven key nutrient concerns, which can help ensure that patients maintain a balanced and complete diet.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutritional Assessment of the Symptomatic Patient on a Plant-Based Diet: Seven Key Questions. Plotnikoff, GA., Dobberstein, L., Raatz, S.[2023]

In a study of 61 patients with multiple myeloma, those with low carbohydrate intake showed significant improvements in clinical parameters like hemoglobin and albumin compared to those with medium carbohydrate intake, suggesting that diet quality may influence disease outcomes.

Despite the observed effects of diet on clinical parameters, patients' nutrition knowledge did not correlate with their clinical status or nutrient intake, indicating a need for better nutritional education and personalized dietary advice for improving patient health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High Carbohydrate Diet Is Associated with Severe Clinical Indicators, but Not with Nutrition Knowledge Score in Patients with Multiple Myeloma. Borsi, E., Serban, CL., Potre, C., et al.[2021]

Parenteral nutrition is a critical option for cancer patients who cannot consume food orally or through enteral means, particularly in cases of under-nutrition and cachexia, which are linked to poor prognosis and increased morbidity.

While short-term parenteral nutrition can be beneficial for patients with acute gastrointestinal issues, it is not recommended for well-nourished patients due to lack of advantages and potential increased risks; however, it may be life-saving for those with chronic conditions or undergoing specific treatments like hematopoietic stem cell transplantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ESPEN Guidelines on Parenteral Nutrition: non-surgical oncology. Bozzetti, F., Arends, J., Lundholm, K., et al.[2022]

Nutritional therapy for cancer patients focuses on managing factors like taste changes, pain, nausea, and depression that can lead to loss of appetite, and includes education on eating behaviors and the use of nutritional supplements.

Patients showed a preference for milk-based nutritional supplements over synthetic products, suggesting that understanding patient preferences can help healthcare teams choose the most acceptable and effective nutritional support for individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral feeding in the nutritional management of the cancer patient. De Wyes, WD., Herbst, SH.[2015]

Citations

1. mskcc.org mskcc.org/news/diets-for-mgus-smoldering-myeloma-and-multiple-myeloma-q-with-msk-cancer-and-nutrition-experts

Diets for MGUS, Smoldering Myeloma, and Multiple Myeloma Learn how eating a plant-based diet may prevent MGUS and smoldering myeloma from developing into multiple myeloma, according to MSK ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10443185/

Dietary and microbiome evidence in multiple myeloma ... Additionally, the EPIC-Oxford Cohort and NHS and HPFS studies showed a reduced MM risk in those eating a plant-based diet and increased risk in ...

3. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/84/NCT04920084/Prot_SAP_000.pdf

A Pilot Plant-Based Dietary Intervention in Overweight and ... We plan to conduct a pilot nutrition-based intervention study of a whole food, plant-based diet (WFPBD) in overweight and obese MGUS/SMM patients to enable ...

4. healthtree.org healthtree.org/myeloma/community/articles/diet-smm-myeloma-research

Plant-Based Diet & Multiple Myeloma Research A plant-based diet rich in whole grains, fruits, vegetables, and legumes has shown promising results in myeloma management.

5. withpower.com withpower.com/trial/phase-multiple-myeloma-11-2024-b9dd8

Plant-Based Meals for Multiple Myeloma · Info for Participants This clinical trial evaluates the impact of a plant-based whole-foods delivery service on the microbiome in patients with multiple myeloma undergoing an ...

6. bloodcancerstoday.com bloodcancerstoday.com/post/study-identifies-dietary-risk-factors-for-myeloma

Plant-Based Diet Associated With Reduced Myeloma Risk A study found a significant association between a healthy plant-based diet and reduced myeloma risk, attributed to increased fiber intake.

7. trial.medpath.com trial.medpath.com/news/936f321f3f85e9d9/high-fiber-plant-based-diet-shows-promise-in-preventing-multiple-myeloma-progression-in-at-risk-patients

High-Fiber Plant-Based Diet Shows Promise in Preventing ... A small but promising clinical trial suggests that patients at high risk for multiple myelomaSearch disease may be able to delay or prevent cancer progression ...