NOURISH for Cancer

(NOURISH Trial)

Overseen By Crystal Bryant

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Disqualifiers: Dementia, Active psychosis, others

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

Compensation: Varies

Number of Visits: 6

24 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment NOURISH for cancer?

Research shows that addressing malnutrition in cancer patients through nutritional support can improve health outcomes, such as maintaining or gaining weight and improving protein status, which are important for better treatment tolerance and quality of life. ^{1 2 3 4 5}

Is the NOURISH treatment generally safe for humans?

Nutritional treatments like enteral nutrition (feeding through a tube) and total parenteral nutrition (feeding through an IV) have been shown to reduce the risk of adverse events (unwanted side effects) in cancer patients, suggesting they are generally safe. However, separated nutrient infusion may increase the risk of adverse events. ^{6 7 8 9 10}

How does the NOURISH treatment for cancer differ from other treatments?

NOURISH for Cancer is unique because it focuses on nutritional support to prevent or reverse malnutrition in cancer patients, using oral supplementation with compounds like eicosapentaenoic acid (EPA) that may help reduce cancer-associated wasting and improve immune function, unlike traditional cancer treatments that primarily target the tumor itself. ^{11 12 13 14 15}

What is the purpose of this trial?

This study includes a 12-week culinary medicine intervention integrated within the existing YMCA Suncoast Survivorship and Wellness Program Powered by Moffitt. Members of the John Geigle YMCA will be assigned to the NOURISH intervention, which includes biweekly provision of fruit and vegetable bundles, recipe cards, and nutritional education handouts plus 30-minute culinary medicine demonstrations with skill-building training (six total demonstrations focused on fruit and vegetable recipes).

Research Team

Sylvia Crowder, PhD

Principal Investigator

Moffitt Cancer Center

Eligibility Criteria

This trial is for individuals diagnosed with cancer who can speak and read English, are able to provide informed consent, and do not have psychiatric or neurologic conditions that could affect participation. It's integrated within the YMCA Suncoast Survivorship and Wellness Program.

Inclusion Criteria

I do not have any mental health conditions that could affect my participation.

I have been diagnosed with cancer.

Able to speak and read English

Exclusion Criteria

Not meeting all of the above inclusion criteria.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive biweekly provision of fruit and vegetable bundles, recipe cards, and nutritional education handouts plus 30-minute culinary medicine demonstrations with skill-building training

12 weeks

6 visits (in-person)

Maintenance

Participants' adherence to dietary guidelines and maintenance of culinary skills are assessed once fruit and vegetables are no longer provided

Up to 1 year

Follow-up

Participants are monitored for retention and recruitment rates

Up to 1 year

Treatment Details

Interventions

• NOURISH

Trial Overview The NOURISH intervention is being tested over a 12-week period. Participants will receive biweekly fruit and vegetable bundles, recipe cards, nutritional education handouts, plus six culinary medicine demonstrations focused on preparing these foods.

Participant Groups

Group I: NOURISH: NutritiOUs fRuIts and veggieS to improve Health Experimental Treatment 1 Intervention

Intervention Phase: In the intervention phase, members of the John Geigle YMCA will be assigned to the NOURISH intervention, which includes biweekly provision of f/v, recipe cards, and nutritional education handouts plus 30-minute culinary medicine demonstrations with skill-building training (six total demonstrations focused on f/v recipes). Members of the Hernando County YMCA will be assigned to the control condition and participants will receive recipe cards and nutritional education handouts but will not receive f/v or cooking demonstrations. Maintenance Phase: In the maintenance phase, we will better understand adherence to dietary guidelines once f/v are no longer provided and maintenance of culinary skills.

Who Is Running the Clinical Trial?

H. Lee Moffitt Cancer Center and Research Institute

Lead Sponsor

Trials

576

Recruited

145,000+

Findings from Research

Malnutrition is a common yet overlooked issue in cancer patients that can negatively impact survival, quality of life, and increase healthcare costs, highlighting the need for better nutritional care standards.

Quality improvement programs, like the Malnutrition Quality Improvement Initiative (MQii), have proven effective in identifying and addressing malnutrition, suggesting that implementing such programs in cancer care could significantly enhance patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Opportunities for Quality Improvement Programs (QIPs) in the Nutrition Support of Patients with Cancer. Arensberg, MB., Richards, J., Benjamin, J., et al.[2020]

A proactive nutritional assessment and intervention approach at Fox Chase Cancer Center led to a 50%-80% success rate in helping 186 cancer patients maintain or gain weight during therapy, which is crucial for improving cancer prognosis and reducing complications.

In a separate program involving 65 patients, 58% were able to successfully taper off parenteral nutrition, highlighting the effectiveness of tailored nutritional interventions in managing cancer-related weight loss and nutritional deterioration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Definition of standardized nutritional assessment and interventional pathways in oncology. Ottery, FD.[2022]

In a study involving patients receiving S-1 adjuvant chemotherapy, the combination of cystine and theanine significantly reduced the incidence of adverse events (AEs), particularly severe diarrhea, compared to a control group.

Patients taking cystine and theanine also had a higher completion rate of chemotherapy and longer duration of treatment, indicating that these amino acids can enhance the tolerability and effectiveness of S-1 chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral administration of the amino acids cystine and theanine attenuates the adverse events of S-1 adjuvant chemotherapy in gastrointestinal cancer patients. Tsuchiya, T., Honda, H., Oikawa, M., et al.[2018]

Maintaining proper nutrition is crucial for cancer patients, as it supports their overall health and treatment effectiveness; the oncology team must understand factors affecting food acceptance to provide suitable dietary options.

Oral feeding is preferred, and nutritional supplements can help ensure adequate intake, but in cases of severe side effects like nausea or mucositis, intravenous feeding may be necessary to prevent malnutrition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral feedings in the cancer patient. Aker, SN.[2019]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Clinical nutrition guidelines of the French Speaking Society of Clinical Nutrition and Metabolism (SFNEP): Summary of recommendations for adults undergoing non-surgical anticancer treatment. [2014]

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

Opportunities for Quality Improvement Programs (QIPs) in the Nutrition Support of Patients with Cancer. [2020]

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

De novo Creation and Assessment of a Prognostic Fat-Age-Inflammation Index "FAIN" in Patients With Cancer: A Multicenter Cohort Study. [2022]

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

Definition of standardized nutritional assessment and interventional pathways in oncology. [2022]

5. Portugal pubmed.ncbi.nlm.nih.gov

[Research training in nutrition: relevance for medical clinical pratice]. [2012]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Interrelationships between Dietary Outcomes, Readmission Rates and Length of Stay in Hospitalised Oncology Patients: A Scoping Review. [2023]

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

Professional and patient perspectives on nutritional needs of patients with cancer. [2018]

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

The impact of nutritional status, nutritional risk, and nutritional treatment on clinical outcome of 2248 hospitalized cancer patients: a multi-center, prospective cohort study in Chinese teaching hospitals. [2013]

9. Germany pubmed.ncbi.nlm.nih.gov

Nutritional screening tools in daily clinical practice: the focus on cancer. [2022]

10. Japan pubmed.ncbi.nlm.nih.gov

Oral administration of the amino acids cystine and theanine attenuates the adverse events of S-1 adjuvant chemotherapy in gastrointestinal cancer patients. [2018]

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

Nutrition and cancer. [2019]

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

Host-tumor interaction and nutrient supply. [2019]

13. Switzerland pubmed.ncbi.nlm.nih.gov

[Aspects of practical oncology. Oncologic dietetics--treatment of anorexia and cachexia]. [2018]

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

Oral feedings in the cancer patient. [2019]

15. Scotland pubmed.ncbi.nlm.nih.gov

Nutritional support strategies for malnourished cancer patients. [2013]