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

20 Participants Needed

Trial Summary

What is the purpose of this trial?

This clinical trial evaluates the impact of a plant-based whole-foods delivery service on the microbiome in patients with multiple myeloma undergoing an autologous hematopoietic cell transplant. An autologous hematopoietic cell transplant is a procedure in which blood-forming stem cells (cells from which all blood cells develop) are removed, stored, and later given back to the same person. Loss of microbial diversity within the intestinal tract has been associated with poor outcomes for patients receiving autologous stem cell transplantation. A plant-based whole meal delivery service may increase the intake of foods high in fiber and nutrients therefore improve microbial health during the peri-transplant period. In this pilot study, study investigators will explore the feasibility of this approach.

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 evidence supports the effectiveness of a plant-based diet for treating multiple myeloma?

Research suggests that people who follow a plant-based diet, such as vegetarians and vegans, may have a lower risk of developing multiple myeloma compared to those who eat meat. Additionally, a diet high in fruits, vegetables, and whole grains is recommended for cancer survivors to improve quality of life. ^{1 2 3 4 5}

Is a plant-based diet safe for humans?

Plant-based diets, including vegan and vegetarian diets, are generally safe and can be nutritionally sufficient if well-planned. However, poorly-designed plant-based diets may lead to deficiencies in nutrients like vitamin B12, iron, and calcium, so it's important to ensure a balanced intake of essential nutrients. ^{1 6 7 8 9}

How does a plant-based diet differ from other treatments for multiple myeloma?

A plant-based diet is unique because it focuses on nutrition and lifestyle changes rather than medication, aiming to improve overall health and potentially influence cancer progression through increased intake of fruits, vegetables, and whole grains. This approach is different from standard treatments that typically involve chemotherapy or other drug therapies. ^{3 10 11 12 13}

Research Team

Kate Markey

Principal Investigator

Fred Hutch/University of Washington Cancer Consortium

Eligibility Criteria

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.

I will receive outpatient treatment and can have meals brought to me if hospitalized.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

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

Pre-Diagnosis Dietary Patterns and Risk of Multiple Myeloma in the NIH-AARP Diet and Health Study. [2023]

2. Switzerland 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. [2021]

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

Nutrition during and after cancer therapy. [2021]

4. England pubmed.ncbi.nlm.nih.gov

ESPEN Guidelines on Parenteral Nutrition: non-surgical oncology. [2022]

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

Oral feeding in the nutritional management of the cancer patient. [2015]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Plant-based dietary patterns and the risk of digestive system cancers in 3 large prospective cohort studies. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Plant- and animal-based diet quality and mortality among US adults: a cohort study. [2021]

8. Switzerland 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. [2021]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Nutritional Assessment of the Symptomatic Patient on a Plant-Based Diet: Seven Key Questions. [2023]

10. United States 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. [2023]

11. France pubmed.ncbi.nlm.nih.gov

[Cancer of the prostate: influence of nutritional factors. A new nutritional approach]. [2017]

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

Adoption of a plant-based diet by patients with recurrent prostate cancer. [2016]

13. United States 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. [2022]