Nutrition Algorithm for Cancer

Overseen By Marilyn Hammer, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Dana-Farber Cancer Institute

Disqualifiers: Provider does not recommend

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

Compensation: Varies

Number of Visits: Unknown

130 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 Nutrition Algorithm for Cancer Health Outcomes (NACHO)?

Research suggests that nutritional support can help maintain body composition and reduce side effects of cancer treatments, such as chemotherapy, which may improve patient quality of life. However, there is no direct evidence that nutritional support improves tumor response to therapy or increases survival in cancer patients. ^{1 2 3 4 5}

Is the Nutrition Algorithm for Cancer safe for humans?

The research suggests that nutritional interventions, including artificial nutrition, are generally safe and can reduce side effects of cancer treatments like chemotherapy and radiotherapy. They help improve immunity, reduce infection risk, and support recovery, although parenteral nutrition (feeding through a vein) may have more side effects and is used when other methods are insufficient. ^{4 6 7 8 9}

How is the NACHO treatment different from other cancer treatments?

The NACHO treatment is unique because it uses a nutrition algorithm specifically designed to improve health outcomes in cancer patients, focusing on optimizing nutritional status and addressing malnutrition, which is a common issue in cancer care. Unlike traditional treatments that primarily target cancer cells, NACHO emphasizes the importance of nutrition in enhancing quality of life and potentially improving treatment tolerance. ^{1 6 8 10 11}

What is the purpose of this trial?

The goal of this research study is to develop a nutrition algorithm to optimize nutritional status and improve quality of life during for participants who are completing or have completed cancer treatment. The name of the intervention used in this research study is: Nutrition Algorithm for Cancer Health Outcomes (NACHO) (a technology-based platform that houses the algorithms for the person-centered nutrition program)

Research Team

Marilyn Hammer, PhD

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

This trial is for dietitians and oncology clinicians who have worked with at least three patients facing nutritional challenges, members of a Patient and Family Advisory Council (PFAC) over 18 years old, and cancer patients who've finished or are undergoing treatment. Participants must speak English and have access to a device like a computer or smartphone.

Inclusion Criteria

Dietitians/Oncology clinicians: Have worked with at least 3 patients at the study site who had nutritional challenges

Exclusion Criteria

My doctor does not recommend I participate.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Development and Refinement

Development of nutrition algorithm by dietitian panel participants with oncology clinician consultation and refinement through feedback from participants and Family Advisory Council (PFAC) members.

12 months

Multiple group meetings and feedback sessions

Usability Testing

Semi-structured interviews and/or focus groups with participants to evaluate algorithm usability and acceptability.

8 months

Interviews and focus groups

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Nutrition Algorithm for Cancer Health Outcomes (NACHO)

Trial Overview The study is testing the 'Nutrition Algorithm for Cancer Health Outcomes' (NACHO), which is a technology-based platform designed to improve nutrition and quality of life in people recovering from or currently receiving cancer treatment.

Participant Groups

Group I: Nutrition Algorithm (NACHO) Experimental Treatment 1 Intervention

Study procedures will be conducted as follows: * Development of nutrition algorithm by dietitian panel participants with oncology clinician consultation via convened group meetings. * Refinement of draft algorithms through feedback from participants and Family Advisory Council (PFAC) members. * Baseline questionnaires for participants. * Semi-structured interviews and/or focus groups with participants to evaluate algorithm usability and acceptability. * Participant questionnaires.

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

Cancer Nutrition Consortium Inc.

Collaborator

Trials

1

Recruited

130+

Findings from Research

A survey of 14 Dutch Head and Neck Oncology centres revealed significant variations in nutritional interventions during chemoradiotherapy, particularly in the use of gastrostomy for tube feeding, with 77% of centres using it for most patients.

There is a need for standardized dietetic guidelines, as practices varied widely, including the number of dietetic consultations (2 to 7), methods for calculating energy and protein requirements, and the timing for removing gastrostomies after treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutritional interventions in patients with head and neck cancer undergoing chemoradiotherapy: Current practice at the Dutch Head and Neck Oncology centres. Kok, A., van der Lugt, C., Leermakers-Vermeer, MJ., et al.[2022]

Low muscle mass and malnutrition during chemotherapy and radiotherapy can lead to increased toxicity, reduced quality of life, and lower survival rates, highlighting the need for effective nutritional therapy.

Recent guidelines emphasize the importance of timely nutritional interventions for cancer patients, recommending collaboration between oncologists and nutrition specialists to ensure adequate nutritional support, including enteral or parenteral nutrition when necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutritional Therapy in Cancer Patients Receiving Chemoradiotherapy: Should We Need Stronger Recommendations to Act for Improving Outcomes? Cotogni, P., Pedrazzoli, P., De Waele, E., et al.[2020]

Malnutrition is a critical issue for cancer patients, significantly affecting their response to treatment and overall survival, highlighting the need for early nutritional intervention.

The CANCER acronym serves as a guide for developing a comprehensive nutritional plan tailored to individual patient needs, emphasizing the importance of ongoing evaluation and adjustment of nutritional support throughout treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimizing nutrition for patients with cancer. Wilson, RL.[2013]

References

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

Nutritional support of the medical oncology patient. [2007]

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

Nutritional support in the cancer-bearing host. Effects on host and tumor. [2019]

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. Poland pubmed.ncbi.nlm.nih.gov

The role of artificial nutrition in gynecological cancer therapy. [2020]

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

Prognostic value of nutritional impairment on treatment-related toxicity and survival in patients with nasopharyngeal carcinoma taking normal nutrition before radiotherapy. [2021]

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

The impact of multidisciplinary team nutrition management on nutritional and toxicity status in patients with nasopharyngeal carcinoma. [2023]

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

Nutritional interventions in patients with head and neck cancer undergoing chemoradiotherapy: Current practice at the Dutch Head and Neck Oncology centres. [2022]

8. Australia pubmed.ncbi.nlm.nih.gov

Nutritional Therapy in Cancer Patients Receiving Chemoradiotherapy: Should We Need Stronger Recommendations to Act for Improving Outcomes? [2020]

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

Chemotherapy dose intensity predicted by baseline nutrition assessment in gastrointestinal malignancies: A multicentre analysis. [2017]

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

Optimizing nutrition for patients with cancer. [2013]

11. Spain pubmed.ncbi.nlm.nih.gov

NUTRI-ONCOCARE: New integral nutrition care model to prevent and treat malnutrition in cancer patients. [2021]