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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial focuses on creating a nutrition algorithm to improve nutritional health and quality of life during or after cancer treatment. The study uses a technology-based platform called NACHO (Nutrition Algorithm for Cancer Health Outcomes) to develop personalized nutrition plans. Participants will refine this tool by providing feedback through questionnaires and interviews. Ideal participants have completed or are undergoing cancer treatment and have access to a device like a smartphone or computer to engage with the study. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance cancer care for future patients.

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 prior data suggests that this nutrition algorithm is safe for cancer patients?

Research has shown that nutrition plans, such as the Nutrition Algorithm for Cancer Health Outcomes (NACHO), are generally safe. These plans can help reduce some side effects of cancer treatments, allowing most people to tolerate them well.

The NACHO program is being developed to enhance nutrition and quality of life for individuals who have undergone cancer treatment. Although specific safety data on NACHO is not yet available, using nutrition to support health is generally considered safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Nutrition Algorithm for Cancer Health Outcomes (NACHO) because it offers a personalized approach to dietary management for cancer patients. Unlike standard nutritional guidelines, which can be generalized and not specific to individual needs, NACHO is developed and refined with input from dietitians, oncology clinicians, and patients themselves. This collaborative approach aims to create a tailored nutrition plan that enhances the health outcomes of cancer patients by focusing on usability and acceptability. By involving patients and their families in the development process, NACHO is positioned to be a more user-friendly and effective tool in managing nutrition during cancer treatment, potentially leading to better overall health and quality of life for patients.

What evidence suggests that the Nutrition Algorithm for Cancer Health Outcomes (NACHO) is effective for improving nutritional status and quality of life in cancer patients?

Research shows that the Nutrition Algorithm for Cancer Health Outcomes (NACHO) aims to improve nutrition and quality of life for cancer patients. In this trial, the NACHO system will create a personalized nutrition plan to support patients during or after cancer treatment. Early studies suggest that customized nutrition positively affects health for those receiving cancer treatment. Although specific data on the NACHO system is not yet available, existing research supports the idea that personalized nutrition can help cancer patients feel better and recover more effectively. ^{1 2 4 5 6}

Who Is on the Research Team?

Marilyn Hammer, PhD

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

Citations

1. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/69/NCT05825469/Prot_SAP_000.pdf

Development and Testing of Nutritional Algorithms We hypothesize that using NACHO will optimize patient nutritional status and improve QOL. This single-site study will accrue a sample of up to ...

2. withpower.com withpower.com/trial/phase-malnutrition-7-2023-eccfe

Nutrition Algorithm for Cancer · Info for Participants The NACHO treatment is unique because it uses a nutrition algorithm specifically designed to improve health outcomes in cancer patients, focusing on optimizing ...

3. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/447415

Development and Testing of Nutritional Algorithms (NACHO) 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 ...

4. app.trialscreen.org app.trialscreen.org/trials/nutrition-poor-development-testing-nutritional-algorithms-nacho-trial-nct05825469

Development and Testing of Nutritional Algorithms (NACHO) Participants will provide feedback to help refine a nutrition algorithm called Nutrition Algorithm for Cancer Health Outcomes (NACHO). Participation will ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10290234/

Nutrition as prevention for improved cancer health outcomes We identified 15 unique studies examining nutrition support interventions before cancer treatment (Table 4) (23-37).

6. dana-farber.org dana-farber.org/clinical-trials/22-637

Development and Usability Testing of Nutrition Algorithms ... 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 ...