Resistance Training for Pancreatic Cancer

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Must be taking: FOLFIRINOX chemotherapy

Disqualifiers: Non-English, Cardiac disease, Pregnancy, others

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

Compensation: Varies

Number of Visits: 4

Duration: 8-12 weeks

25 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This clinical trial studies the safety of a real-time tele-exercise resistance training (training done using a tablet) in maintaining skeletal muscle, strength, physical function, and health-related quality of life in patients with pancreatic cancer who are receiving combination chemotherapy or have undergone surgery for the treatment of pancreatic cancer. Tele-exercise resistance training may improve physical function and quality of life in patients with pancreatic cancer.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, since the trial involves patients receiving chemotherapy, it's likely that you can continue your current treatment. Please consult with the trial coordinators for specific guidance.

Is resistance training safe for people with pancreatic cancer?

Resistance training, including supervised and home-based programs, has been shown to be safe for people with pancreatic cancer, with no exercise-related adverse events reported in studies. ^{1 2 3 4 5}

How does resistance training differ from other treatments for pancreatic cancer?

Resistance training is unique for pancreatic cancer as it focuses on maintaining or improving muscle mass and strength, which is crucial due to the high risk of muscle loss in these patients. Unlike traditional treatments like chemotherapy, this approach uses physical exercise to enhance physical function and potentially improve quality of life. ^{1 2 4 6 7}

What data supports the effectiveness of the treatment Tele-exercise Resistance Training for pancreatic cancer?

Research shows that resistance training can help maintain or improve muscle mass and strength in pancreatic cancer patients, which is important because these patients often experience muscle loss. Studies have found that such training can positively impact physical fitness, mobility, and body composition, which are crucial for improving overall health and survival in these patients. ^{2 3 5 7 8}

Who Is on the Research Team?

Karen M. Basen-Engquist

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults with advanced pancreatic cancer who are undergoing chemotherapy or have had surgery. They must be in good physical condition (ECOG 0-1), able to participate in tele-exercise sessions, and have Wi-Fi at home. Pregnant women, non-English speakers, those already doing regular resistance training, or with certain health issues like severe pain or unstable heart disease cannot join.

Inclusion Criteria

You are able to perform daily activities without any major issues (ECOG performance status 0-1).

Able to schedule baseline (T0) appointment for fitness testing and program teaching at the Behavioral Research and Treatment Center (BRTC) or able to schedule remote fitness testing and program teaching

Able to understand the description of the study, exercise program, and willing to participate

Exclusion Criteria

Non-English speaking

Unable to complete the baseline assessment questionnaires or functional assessments

Screen failure for exercise safety based on Physical Activity Readiness Questionnaire (PAR-Q) and/or Patient Reported Outcomes Measurement Information System (PROMIS) questions

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo tele-exercise resistance training sessions during chemotherapy or post-surgery

8-12 weeks

At least 4 tele-RT sessions every 2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Tele-exercise Resistance Training

Trial Overview The study tests a tele-exercise resistance training program using tablets to see if it helps maintain muscle strength, physical function, and life quality for pancreatic cancer patients during chemo or post-surgery. Participants will do exercises remotely while being monitored by the research team.

How Is the Trial Designed?

Group I: Supportive care (resistance training) Experimental Treatment 4 Interventions

SEE DETAILED DESCRIPTION.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Published Research Related to This Trial

A 6-month progressive resistance training program was feasible for pancreatic cancer patients, with adherence rates of 64.1% for supervised training and 78.4% for home-based training.

Supervised resistance training significantly improved muscle strength in elbow flexors/extensors and knee extensors compared to usual care, indicating that structured exercise can be beneficial for maintaining muscle mass in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Progressive Resistance Training to Impact Physical Fitness and Body Weight in Pancreatic Cancer Patients: A Randomized Controlled Trial. Wiskemann, J., Clauss, D., Tjaden, C., et al.[2019]

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]

A three-month resistance training program significantly improved mobility in patients with pancreatic cancer-induced cachexia, as evidenced by better performance in walking and chair rise tests.

The resistance training also led to notable increases in muscle strength and lean body mass, indicating its efficacy in enhancing physical function in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Resistance Training Impact on Mobility, Muscle Strength and Lean Mass in Pancreatic Cancer Cachexia: A Randomized Controlled Trial. Kamel, FH., Basha, MA., Alsharidah, AS., et al.[2022]

A scoping review of 15,708 articles identified only 62 relevant studies on diet and exercise interventions for patients with pancreatic cancer, highlighting a significant gap in research on this topic.

Most studies focused on dietary interventions, particularly omega-3 fatty acids, while only a small number examined exercise, indicating a need for more comprehensive research to understand how these interventions can help combat malnutrition and muscle wasting in pancreatic cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diet and Exercise Interventions in Patients With Pancreatic Cancer: A Scoping Review. Kasvis, P., Kilgour, RD.[2022]

In a study of 65 pancreatic cancer patients, progressive resistance training did not significantly change body composition, but it showed strong correlations between muscle area and muscle strength, suggesting that maintaining muscle mass is crucial for physical function.

High visceral-to-subcutaneous fat ratio (VFR) and loss of muscle mass were identified as predictors of poor overall survival, highlighting the importance of body composition in the prognosis of pancreatic cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of progressive resistance training on CT quantified muscle and adipose tissue compartments in pancreatic cancer patients. Wochner, R., Clauss, D., Nattenmüller, J., et al.[2021]

A systematic review of 7 trials involving 201 patients with pancreatic cancer showed that exercise training is safe and feasible, with no reported adverse events and high retention rates (71% to 90%).

Exercise programs led to significant improvements in cancer-related fatigue, psychological distress, and physical function, suggesting that exercise may positively impact the health and well-being of patients with pancreatic cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise Medicine in the Management of Pancreatic Cancer: A Systematic Review. Luo, H., Galvão, DA., Newton, RU., et al.[2023]

In a study of 59 pancreatic cancer patients, a significant portion had low protein (33.9%) and energy intake (39.0%), indicating a risk of malnutrition before starting a 6-month resistance training program.

After the intervention, which included both supervised and home-based resistance training, there was no significant change in nutritional intake compared to usual care, suggesting that resistance training alone does not improve nutritional status in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutrition Intake and Nutrition Status of Pancreatic Cancer Patients: Cross-Sectional and Longitudinal Analysis of a Randomized Controlled Exercise Intervention Study. Steindorf, K., Clauss, D., Rötzer, I., et al.[2022]

In a study involving 20 patients with potentially resectable pancreatic adenocarcinoma, 75% adhered to a home-based exercise program during preoperative chemotherapy, reporting an average of 156 minutes of exercise weekly.

The exercise program was safe, with no adverse events reported, and significantly increased physical activity levels in patients who initially had low baseline activity, suggesting that exercise can be effectively integrated into treatment for pancreatic cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-based exercise during preoperative therapy for pancreatic cancer. Ngo-Huang, A., Parker, NH., Wang, X., et al.[2023]

Citations

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

Progressive Resistance Training to Impact Physical Fitness and Body Weight in Pancreatic Cancer Patients: A Randomized Controlled Trial. [2019]

2. 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]

3. England pubmed.ncbi.nlm.nih.gov

Resistance Training Impact on Mobility, Muscle Strength and Lean Mass in Pancreatic Cancer Cachexia: A Randomized Controlled Trial. [2022]

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

Diet and Exercise Interventions in Patients With Pancreatic Cancer: A Scoping Review. [2022]

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

Impact of progressive resistance training on CT quantified muscle and adipose tissue compartments in pancreatic cancer patients. [2021]

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

Exercise Medicine in the Management of Pancreatic Cancer: A Systematic Review. [2023]

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

Nutrition Intake and Nutrition Status of Pancreatic Cancer Patients: Cross-Sectional and Longitudinal Analysis of a Randomized Controlled Exercise Intervention Study. [2022]

8. Germany pubmed.ncbi.nlm.nih.gov

Home-based exercise during preoperative therapy for pancreatic cancer. [2023]