Nutritional Intervention for Cancer

(N-PICO Trial)

Overseen By Randall F Holcombe, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Vermont Medical Center

Disqualifiers: Acute leukemia, Head & neck cancer, others

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

Compensation: Varies

Number of Visits: 1

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests different levels of remote nutritional support for cancer patients about to start treatment. It aims to determine if these nutritional interventions, known as Nutritional Prehabilitation, can improve patients' adherence to cancer treatment and overall quality of life. The trial compares low-intensity support, such as a one-time consultation, with high-intensity support, including monthly follow-ups. It suits patients with invasive cancer who are beginning treatments like chemotherapy or immunotherapy and are open to remote nutritional guidance. Participants will provide feedback on their health and daily habits through surveys. As an unphased trial, this study offers a unique opportunity for patients to contribute to innovative research that could enhance cancer care.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It focuses on nutritional interventions, so it's best to discuss your medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that nutritional prehabilitation is generally safe and well-tolerated by patients. Studies have found that these programs can assist cancer patients, particularly as they prepare for surgery. Nutritional support, for instance, can shorten hospital stays and accelerate recovery. Patients typically do not experience serious side effects from these programs.

One study demonstrated that patients with head and neck cancer improved their nutrition and overall health through these programs, with no major negative effects reported.

Overall, evidence suggests that nutritional prehabilitation is safe for cancer care. It aims to enhance a patient's nutrition to help them better manage their treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this nutritional prehabilitation approach for cancer patients because it aims to enhance patient resilience and recovery before treatment even begins. Unlike traditional methods that focus on post-treatment recovery, this approach is proactive, preparing the body by optimizing nutrition and physical well-being beforehand. The trial explores diverse delivery methods, including both urban and rural settings, and varying levels of intensity, making it adaptable to different patient needs and lifestyles. By focusing on prehabilitation, researchers hope to improve overall treatment outcomes and quality of life for cancer patients.

What evidence suggests that this trial's nutritional interventions could be effective for cancer patients?

This trial will explore various nutritional prehabilitation strategies for cancer patients, with different arms focusing on urban and rural settings, as well as low- and high-intensity interventions. Studies have shown that preparing the body with good nutrition before cancer treatment can lead to better outcomes. Research indicates that improving nutrition before surgery can aid in faster recovery and reduce hospital stays. Patients in these programs often experience less fatigue and maintain more activity during treatment. Early findings suggest that both simple and more involved nutritional support can help patients adhere to their cancer treatment plans and improve quality of life. This approach aims to help the body better handle the stress of cancer treatments. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

The N-PICO trial is for cancer patients, both in rural and urban settings, who are malnourished or experiencing cachexia. Participants must be about to start invasive cancer treatment. The study excludes individuals who cannot comply with the nutritional intervention protocols or have conditions that might interfere with the study's assessments.

Inclusion Criteria

I am willing to have a remote nutritional consultation and complete surveys.

I am getting treatment at a qualified outpatient cancer clinic.

I am starting or have just started treatment for my invasive cancer.

Exclusion Criteria

I have been diagnosed with acute leukemia.

I have been diagnosed with a specific type of cancer and am experiencing severe weight loss or I use a feeding tube.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a low- or high-intensity remote nutritional intervention for 6 weeks

6 weeks

1 initial consultation, monthly follow-ups for high-intensity group

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Nutritional Prehabilitation

Trial Overview This trial tests low- vs high-intensity remote nutritional interventions' effects on treatment adherence and quality of life in cancer patients. It compares a basic consultation with written advice against more involved monthly follow-ups plus detailed guidance to see which improves outcomes better.

How Is the Trial Designed?

Group I: Urban, Remote, Low-Intensity Experimental Treatment 2 Interventions

Urban, Remote, Low-Intensity

Group II: Urban, Remote, High-Intensity Experimental Treatment 2 Interventions

Urban, Remote, High-Intensity

Group III: Urban, In-Person, Low-Intensity Experimental Treatment 2 Interventions

Urban, In-Person, Low-Intensity

Group IV: Urban, In-Person, High-Intensity Experimental Treatment 2 Interventions

Urban, In-Person, High-Intensity

Group V: Rural, Remote, Low-Intensity Experimental Treatment 1 Intervention

Rural, Remote, Low-Intensity

Group VI: Rural, Remote, High-Intensity Experimental Treatment 1 Intervention

Rural, Remote, High-Intensity

Who Is Running the Clinical Trial?

University of Vermont Medical Center

Lead Sponsor

Trials

46

Recruited

25,900+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10552833/

Nutritional interventions in prehabilitation for cancer surgery Multimodal prehabilitation is proven to improve length of hospital stay and postoperative outcomes, with nutrition forming a significant part of ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2405457724015699

Changes in nutritional status and effectiveness of the ... Our study provides evidence for the positive impact of multimodal prehabilitation on preoperative nutritional status in adult patients with CRC.

3. aspenjournals.onlinelibrary.wiley.com aspenjournals.onlinelibrary.wiley.com/doi/10.1002/ncp.11079

Evaluation of nutrition components within prehabilitation ... Results from the multicenter Nutritional Outcomes of Patients Undergoing Resection for Upper Gastrointestinal Cancer in Australian Hospitals ...

4. bmccancer.biomedcentral.com bmccancer.biomedcentral.com/articles/10.1186/s12885-024-13023-w

Efficacy of Prehabilitation in cancer patients: an Rcts ... Patients with cancer (PwC) who undergo specific treatments reported greater fatigue and reduced functional capacity as predominant outcomes, ...

5. frontiersin.org frontiersin.org/journals/nutrition/articles/10.3389/fnut.2021.644723/full

Current Landscape of Nutrition Within Prehabilitation ... Background: Prehabilitation aims to improve functional capacity prior to cancer treatment to achieve better psychosocial and clinical outcomes.

6. sciencedirect.com sciencedirect.com/science/article/pii/S2405457723021915

Nutritional prehabilitation in head and neck cancer Nutritional and physical prehabilitation interventions have a positive effect on the nutritional status and clinical outcomes of patients with head and neck ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT07072377?lead=University+of+Vermont&locStr=United+States&country=United+States&aggFilters=status%3A&start=2000-01-01_

Nutritional Prehabilitation to Improve Cancer Outcomes (N- ... This pilot study is intended to inform the design of a future larger trial by generating preliminary data on the practicality and clinical utility of ...