NIH/NCI 470 - Precision Nutrition Interventions to Reduce Cancer-Related Symptoms

Fast-Track proposals will be accepted.

Direct-to-Phase II proposals will be accepted.

Number of anticipated awards: 2-3

Budget (total costs, per award):

Phase I: up to $400,000 for up to 12 months

Phase II: up to $2,250,000 for up to 2 years

PROPOSALS THAT EXCEED THE BUDGET OR PROJECT DURATION LISTED ABOVE MAY NOT BE FUNDED.

Summary

Cancer and cancer treatment can precipitate complex symptoms, termed nutrition impact symptoms, that negatively affect food intake, digestion, absorption, utilization of nutrients, and overall nutritional health. Common symptoms reported include anorexia, early satiety, constipation, diarrhea, and malabsorption. Other reported symptoms include dysphagia, mucositis, esophagitis, oral candidiasis, acid reflux, thick saliva, fatigue, and alterations in taste and smell. These nutrition impact symptoms negatively affect overall nutritional health and reduce patients’ quality of life, which can further impact cancer treatment adherence and is linked to suboptimal treatment outcomes.

Early identification and effective management of symptoms affecting nutrition can help maintain patient’s nutritional status, protect quality of life, and bolster tolerance for cancer treatment, which is vital for most cancer types. Although some assessment tools are available that help practitioners to ascertain the presence, intensity, duration, and timing of these symptoms, there remains a lack of rigorous research and evidence-based treatment strategies to reduce these symptoms. There is a significant need and opportunity to develop new and effective nutritional interventions that could minimize nutrition-impact symptoms and enhance the quality of life for cancer patients. The NIH Office of Disease Prevention held a Pathways to Prevention workshop to examine the evidence and interplay between nutritional interventions in cancer health outcomes. A report of the workshop by an independent panel made a key recommendation to develop precision nutrition interventions to alleviate nutrition-impact symptoms that arise as side effects from cancer treatment or result from tumor burden. Developing nutritional interventions, such as nutritional agents or compounds, food products, and/or medical foods, would greatly help patients manage the symptoms of cancer and its treatment on health outcomes.

Project Goals

The goal of this contract topic solicitation is to develop new and/or better targeted nutritional products for patients and their clinical care teams when patients are experiencing nutrition impact symptoms. Importantly, such products could address negative outcomes associated with nutrition impact symptoms, like a patient’s nutritional status, quality of life, and tolerance of cancer treatment. The technical scope of this initiative encompasses identifying a nutritional intervention, establishing ownership of and/or license for the product, and demonstrating that the product alleviates the identified symptoms. The product can be a nutritional agent, food product, or medical food. Examples for potential interventions include:

Fat and protein food enhancers (that do not change the character of the food) to increase calories and/or specific amino acid intake (i.e., medium-chain triglycerides).
Ice pops containing specific amino acids and minerals to reduce the severity of mucositis.
High calorie (500 kcal) oral nutritional supplements with low satiety and minimize sensations of sweetness.
Miracle berry, synsepalum dulcificum, incorporated into food products to decrease bitter taste.
The herb, Gymnema sylvestra, popularly known as “gurmar” for its distinct property as a sugar destroyer, incorporated into food products to depress the taste of sweetness.

Activities not responsive to this announcement:

Drug development that targets nutrition impact symptoms; mobile app technology for controlling behavioral interventions relating to nutrition impact symptoms; agents that require administration by intravenous delivery to patients.

Phase I Activities and Deliverables:

Submission of a technical report, and/or proof of concept experiments and demonstration that the intervention is feasible, and scalable.
Demonstrate the safety of the new food or ingredient. Demonstrate that any ingredients used in the product are safe and contain Generally Recognized As Safe (GRAS) /Food grade materials.
If the food ingredient is not GRAS, submission of a Food Additive Petition to the FDA is required.
Indicate a consultation with the US Food and Drug Administration (FDA) occurred.
Address any food safety concerns inherent in producing food (e.g., microbiological quality, allergenicity, quality control/GMP).
Demonstrate labeling requirements as established by the FDA, if necessary.
Propose appropriate analytical strategies for verifying and validating the composition, quality, and suitability of the product. Product information may include name of the product (brand name, chemical or taxonomic nomenclature); ingredients of the product (active and inactive); supplier; parts of the product to be used (e.g., root, stem, leaf) as applicable.
Ensure the appropriate certifications for such things as laboratory quality control specifications and procedures for raw material, in-process, and finished product testing.
Illustrate methodology for measuring efficacy of the nutrition intervention on the nutrition impact symptom(s).
For proof-of-concept experiments involving human subjects, provide justification for the number of subjects required, their health status, justification for the proposed doses/concentrations and dosing schedule; any known safety issues regarding the doses; brief description of the pharmacokinetics and pharmacodynamics of the known components of the product and any biological or chemical marker(s), such as electrolyte and glucose level changes, gastrointestinal effects, if known and if applicable.

Phase II Activities and Deliverables:

Complete experiments and assessments according to the plan developed in Phase I (e.g., demonstration of desired function, safety assessment, and GMP manufacturing).
Demonstrate successful execution of the analytical strategies proposed in phase I, for verifying and validating the quality and suitability of the product for patients with cancer, including stability under accelerated storage test conditions.
Conduct the activities needed to support applying for GRAS status or other regulatory status of the ingredient, when indicated.
Develop and execute an appropriate regulatory strategy.
Ensure nutrient uniformity and stability as well as nutrient content and quantity represented on the labeling.
Ensure packaging and seal integrity.
Demonstrate the capability to scale up the technology to low-rate initial production, and a technology path towards production of the product in larger amounts suitable for supply.
In lieu of human/animal trials, applicants may demonstrate the bio-accessibility of the ingredient by appropriate chemical analysis procedures.
Conduct studies to evaluate and test patient acceptability and feasibility.
Applicants should contact the relevant review division within FDA/Center for Drug Evaluation and Research (CDER) (https://www.fda.gov/drugs/types-applications/investigational-new-drug-ind-application) if they have questions about whether an IND is required for their clinical study involving a marketed food.
Conduct studies with cancer patients to determine the efficacy of the nutritional intervention on the nutrition impact symptom. Include symptom grading scales, as available.
Demonstrate protection of intellectual property (i.e., patents, trade secrets, trademarks, copyrights, and contracts and agreements), as indicated.

Receipt date: Friday, October 18, 2024, 5:00 p.m. ET

Apply for this topic on the Contract Proposal Submission (eCPS) website.

View the full PHS2025-1 Contract Solicitation.