Exercise and Nutrition Program for Pancreatic Cancer

Overseen By Morgan Bean

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Disqualifiers: Unstable cardiac, Pulmonary, Musculoskeletal, others

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

Compensation: Varies

Number of Visits: Unknown

26 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of the study is to examine the feasibility and acceptability of an exercise and nutrition "prehabilitation" program for patients preparing for pancreatic cancer resection (removal).

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Remote Exercise and Nutritional Prehabilitation for pancreatic cancer?

Research shows that exercise and nutritional prehabilitation can improve physical function and quality of life for patients with pancreatic cancer. Studies indicate that these programs can reduce postoperative complications and hospital stays, highlighting the importance of physical activity and nutrition during treatment. ^{1 2 3 4 5}

Is the Exercise and Nutrition Program for Pancreatic Cancer safe for humans?

Research suggests that exercise and nutrition programs, including prehabilitation, are generally safe for people undergoing cancer surgery. These programs can improve fitness and reduce complications, such as infections, after surgery. ^{1 3 4 6 7}

How does the Remote Exercise and Nutritional Prehabilitation treatment differ from other treatments for pancreatic cancer?

This treatment is unique because it combines exercise and nutrition to improve physical fitness and quality of life before surgery, unlike traditional treatments that focus solely on medical or surgical interventions. It emphasizes home-based exercise and nutritional support to address malnutrition and enhance recovery, which is often overlooked in standard care. ^{1 3 4 5 8}

Research Team

Nathan Parker, PhD, MPH

Principal Investigator

Moffitt Cancer Center

Pamela Hodul, MD

Principal Investigator

Moffitt Cancer Center

Eligibility Criteria

This trial is for individuals preparing for pancreatic cancer surgery. It's designed to see if a program of exercise and nutrition advice before the operation can help patients.

Inclusion Criteria

My pancreatic cancer is confirmed and might be removable with surgery.

I can take care of myself and am up and about more than 50% of my waking hours.

I am currently receiving chemotherapy that includes both radiation and surgery.

Exclusion Criteria

I regularly exercise, focusing on all major muscle groups twice a week.

Screen failure for exercise safety based on PAR-Q

My pain level is at least 7 out of 10.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Prehabilitation

Participants undergo a remote exercise and nutritional prehabilitation program to prepare for pancreatic cancer resection

16 weeks

Follow-up

Participants are monitored for safety and effectiveness after the prehabilitation program

4 weeks

Treatment Details

Interventions

• Remote Exercise and Nutritional Prehabilitation

Trial Overview The study tests a 'prehabilitation' program that includes physical activity, resistance training, and nutrition counseling to improve patient outcomes before pancreatic cancer surgery.

Participant Groups

Group I: Physical activity, tele-resistance training, nutrition counseling and monitoring group (RT/N) Experimental Treatment 3 Interventions

Group II: Physical activity, nutrition counseling and monitoring group (PA/N) Experimental Treatment 2 Interventions

Who Is Running the Clinical Trial?

H. Lee Moffitt Cancer Center and Research Institute

Lead Sponsor

Trials

576

Recruited

145,000+

Findings from Research

A randomized trial involving 151 patients with pancreatic cancer showed that both a prescribed exercise program and enhanced usual care led to significant improvements in walking distance, with Arm B (exercise) showing a greater mean increase of 27.3 meters compared to 18.6 meters in Arm A (usual care).

While both groups had similar overall activity levels, Arm B participants increased their strength training sessions significantly more, indicating that a structured exercise program can enhance physical fitness in patients preparing for surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a Pragmatic Home-based Exercise Program Concurrent With Neoadjuvant Therapy on Physical Function of Patients With Pancreatic Cancer: The PancFit Randomized Clinical Trial. Ngo-Huang, AT., Parker, NH., Xiao, L., et al.[2023]

Neoadjuvant treatment (NAT) is now the standard care for patients with locally advanced pancreatic ductal adenocarcinoma (PDAC), but it can lead to a decline in nutritional status, which may affect treatment tolerance and surgical outcomes.

Implementing a nutritional prehabilitation program during NAT could enhance patients' ability to complete therapy and improve their recovery and survival rates, highlighting the importance of nutritional management in this treatment phase.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neoadjuvant treatment: A window of opportunity for nutritional prehabilitation in patients with pancreatic ductal adenocarcinoma. Trestini, I., Cintoni, M., Rinninella, E., et al.[2021]

Prehabilitation programs before pancreatic surgery can improve postoperative outcomes, such as reducing delayed gastric emptying and shortening hospital stays, based on a systematic review of six studies involving 193 patients.

Supervised exercise programs showed better adherence and effectiveness in improving muscle mass and function compared to unsupervised programs, highlighting the importance of structured prehabilitation in enhancing recovery after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prehabilitation prior to surgery for pancreatic cancer: A systematic review. Bundred, JR., Kamarajah, SK., Hammond, JS., et al.[2021]

Pancreatic cancer (PC) is associated with malnutrition and sarcopenia, which negatively affect postoperative recovery and overall outcomes, highlighting the need for timely nutritional evaluations and interventions in patients undergoing surgery.

Evidence-based nutritional strategies, including pre- or perioperative medical nutrition and immunonutrition, can significantly reduce postoperative complications and hospital stays, suggesting that proactive nutritional care should be integrated into treatment plans for patients with resectable and borderline resectable PC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immunonutrition and prehabilitation in pancreatic cancer surgery: A new concept in the era of ERAS® and neoadjuvant treatment. De Luca, R., Gianotti, L., Pedrazzoli, P., et al.[2023]

In a study of 50 patients with resectable pancreatic adenocarcinoma, engaging in a home-based exercise program led to significant improvements in physical function, as measured by tests like the 6-minute walk test and sit-to-stand test.

Increased levels of light physical activity were linked to better health-related quality of life, while more sedentary behavior was associated with lower quality of life, emphasizing the importance of staying active during cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-Based Exercise Prehabilitation During Preoperative Treatment for Pancreatic Cancer Is Associated With Improvement in Physical Function and Quality of Life. Ngo-Huang, A., Parker, NH., Bruera, E., et al.[2023]

A systematic review of 25 randomized-controlled trials involving 2682 cancer patients found that prehabilitation programs focusing on exercise training did not show clear benefits over usual care in improving health-related quality of life or reducing postoperative complications.

The overall certainty of the evidence was assessed as very low due to serious methodological concerns, indicating that more research is needed to determine the true effectiveness of prehabilitation programs for cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prehabilitation programs for individuals with cancer: a systematic review of randomized-controlled trials. Meneses-Echavez, JF., Loaiza-Betancur, AF., Díaz-López, V., et al.[2023]

This multicenter study is assessing the feasibility of a 4-week home-based exercise prehabilitation program for 30 unfit patients scheduled for pancreatic surgery, focusing on improving their aerobic capacity and functional mobility.

The program includes high-intensity interval training and functional exercises, aiming to enhance patient outcomes and potentially reduce complications in this high-risk group, with results expected to inform future prehabilitation strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supervised Home-Based Exercise Prehabilitation in Unfit Patients Scheduled for Pancreatic Surgery: Protocol for a Multicenter Feasibility Study. Hildebrand, ND., Wijma, AG., Bongers, BC., et al.[2023]

In a study of 137 patients undergoing surgery for pancreatic cancer, a significant prevalence of malnutrition was found, with 62.3% experiencing over 5% weight loss prior to surgery.

Implementing a dietetic intervention for at least 14 days led to an average weight gain of 1.8% and improved handgrip strength by 7.9%, along with significant reductions in gastrointestinal symptoms, highlighting the importance of nutritional support in enhancing recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

From prehab to rehab: Nutritional support for people undergoing pancreatic cancer surgery. Bibby, N., Rajai, A., O'Reilly, DA.[2023]

References

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

Effects of a Pragmatic Home-based Exercise Program Concurrent With Neoadjuvant Therapy on Physical Function of Patients With Pancreatic Cancer: The PancFit Randomized Clinical Trial. [2023]

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

Neoadjuvant treatment: A window of opportunity for nutritional prehabilitation in patients with pancreatic ductal adenocarcinoma. [2021]

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

Prehabilitation prior to surgery for pancreatic cancer: A systematic review. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Immunonutrition and prehabilitation in pancreatic cancer surgery: A new concept in the era of ERAS® and neoadjuvant treatment. [2023]

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

Home-Based Exercise Prehabilitation During Preoperative Treatment for Pancreatic Cancer Is Associated With Improvement in Physical Function and Quality of Life. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Prehabilitation programs for individuals with cancer: a systematic review of randomized-controlled trials. [2023]

7. Canada pubmed.ncbi.nlm.nih.gov

Supervised Home-Based Exercise Prehabilitation in Unfit Patients Scheduled for Pancreatic Surgery: Protocol for a Multicenter Feasibility Study. [2023]

8. England pubmed.ncbi.nlm.nih.gov

From prehab to rehab: Nutritional support for people undergoing pancreatic cancer surgery. [2023]