Resistance Training + Protein Supplementation for Pancreatic Cancer

Overseen By Christina M Dieli-Conwright, PhD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Dana-Farber Cancer Institute

Disqualifiers: Uncontrolled illness, Other malignancies, Metastatic, others

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

Compensation: Varies

Number of Visits: 3

Duration: 16 weeks

45 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a home-based resistance exercise program, combined with protein supplements, can help people with pancreatic cancer maintain or improve muscle mass during chemotherapy. Researchers are testing three approaches: exercise with protein supplements, exercise alone, and a stretching program as a control. The trial seeks non-metastatic pancreatic cancer patients who are starting chemotherapy, currently exercise less than an hour a week, and are non-smokers. Participants should be able to engage in exercise without any major health issues that prevent physical activity.

As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance quality of life during cancer treatment.

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 is best to discuss this with the trial coordinators or your doctor.

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

Research shows that resistance training is safe for people with pancreatic cancer. Exercise can improve muscle strength and quality of life and is generally well-tolerated, even for those with serious health issues.

Studies have also indicated that combining resistance training with protein supplements is safe. This combination might help maintain muscle mass, which is important because people with cancer often lose muscle.

Overall, both resistance training alone and with protein supplements are safe in clinical settings. Participants in studies have generally handled these activities well without major side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because they combine resistance training with protein supplementation in a unique approach for pancreatic cancer patients. Unlike traditional cancer treatments like chemotherapy and surgery, which target the cancer cells directly, these interventions aim to improve muscle mass and strength, potentially enhancing patients' overall well-being and quality of life during chemotherapy. The addition of protein supplementation may help in optimizing muscle recovery and growth, offering a holistic benefit that standard treatments don't address. This innovative approach focuses on the patients' physical resilience, which could lead to better treatment outcomes and improved tolerance to conventional therapies.

What evidence suggests that this trial's treatments could be effective for pancreatic cancer?

In this trial, participants will be randomly assigned to different groups to evaluate the effects of resistance training and protein supplementation. A previous study showed that combining weight training with protein supplements increased muscle mass in people with pancreatic cancer undergoing chemotherapy. Research suggests this combination can help reduce muscle loss, which is common in cancer patients. Participants in this trial may receive this combination treatment.

For those focusing only on resistance training, studies have shown it is safe and can boost muscle strength and improve quality of life. Participants in this trial may also be assigned to a group receiving only resistance training. Although this did not directly extend survival, having more muscle and strength is linked to better overall health. Overall, both methods seem promising for managing muscle loss in pancreatic cancer patients. ^{1 2 3 5 6}

Who Is on the Research Team?

Christina M Dieli-Conwright, PhD

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

This trial is for adults over 18 with non-metastatic pancreatic cancer starting chemotherapy. They must understand English or Spanish, be able to exercise (not currently doing moderate/vigorous activity over 60 minutes/week), not smoke, and can travel to DFCI for check-ups. Excluded are those with uncontrolled illnesses, other cancers, or conditions preventing exercise.

Inclusion Criteria

You do not engage in at least 60 minutes of moderate or vigorous exercise each week.

Ability to understand and the willingness to sign a written informed consent document

I am starting chemotherapy for my pancreatic cancer that has not spread.

Exclusion Criteria

I do not have any uncontrolled illnesses like infections or unmanaged diabetes, high blood pressure, or thyroid issues.

I don't have any muscle, heart, lung, or nerve conditions that stop me from exercising.

I cannot travel to the clinic for check-ups.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo resistance training and protein supplementation or control interventions during chemotherapy

16 weeks

3 visits (in-person) for evaluations, virtual sessions 3 times a week

Follow-up

Participants are monitored for changes in skeletal muscle mass, physical function, and quality of life

4 weeks

Open-label extension (optional)

Participants in the attention control group may opt into the exercise intervention after treatment

16 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Attention Control
• Resistance Training
• Resistance Training and Protein Supplementation

Trial Overview

The RE-BUILD Trial tests if resistance training (RT) combined with protein supplements improves muscle mass in pancreatic cancer patients during chemo compared to RT alone or attention control (home-based stretching).

How Is the Trial Designed?

Group I: Resistance Training (RT) and Protein Supplementation (PS) Experimental Treatment 1 Intervention

Participants will be randomly assigned to the Resistance Training (RT) and Protein Supplementation (PS) group and receive virtually (Zoom) supervised home-based exercise program 3-days a week with daily protein supplementation for the duration of their chemotherapy with a maximum of 16-weeks of exercise. Exercises will be tailored to the participants' fitness levels. Sessions will last \~60 minutes including 5-minute warm-up and 5-minute cool-down. Participants will also have two body composition scans using CT over the span of chemotherapy treatment (maximum 16 weeks) and approximately 3 hours of evaluation of testing on 3 occasions.

Group II: Resistance Training (RT) Experimental Treatment 1 Intervention

Participants will be randomly assigned to the Resistance Training (RT) group and receive virtually (Zoom) supervised home-based exercise program 3-days a week. Exercises will be tailored to the participants' fitness levels. Participants will also have two body composition scans using CT over the span of chemotherapy treatment (maximum 16 weeks) and approximately 3 hours of evaluation of testing on 3 occasions.

Group III: Attention Control (AC) Active Control 1 Intervention

Participants will be randomly assigned to the Attention Control (AC) group and receive instruction on a home-based, 3 days a week stretching program. Participants will also have two body composition scans using CT over the span of chemotherapy treatment (maximum 16 weeks) and approximately 3 hours of evaluation of testing on 3 occasions. The attention control group will be given the option to participate in the exercise intervention after their treatment is completed, with a cap of a 16-week period.

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

Published Research Related to This Trial

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]

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]

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]

Regular resistance exercise combined with adequate protein intake, particularly those rich in essential amino acids and leucine, is crucial for promoting muscle hypertrophy by enhancing muscle protein synthesis (MPS) over breakdown.

The post-exercise period is particularly effective for stimulating MPS, and while various supplements have been tested to enhance this effect, higher protein intake remains the most effective strategy for preserving or increasing muscle mass, especially during weight loss efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A brief review of critical processes in exercise-induced muscular hypertrophy. Phillips, SM.[2022]

In a study of 94 advanced pancreatic cancer patients, early loss of skeletal muscle mass (LSMM) of 10% or more was linked to significantly worse overall survival and progression-free survival, indicating it is a critical prognostic factor.

Baseline sarcopenia was prevalent in 73% of patients, highlighting the importance of monitoring muscle mass in pancreatic cancer treatment, as it may influence treatment outcomes and patient quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The IMPACT study: early loss of skeletal muscle mass in advanced pancreatic cancer patients. Basile, D., Parnofiello, A., Vitale, MG., et al.[2021]

The expert panel recommends that U.S. Armed Forces members consume 1.5-2.0 g of protein per kg of body weight per day during high metabolic demand to maintain muscle mass and performance, while lower intake (0.8-1.5 g/kg/d) is sufficient during low-demand periods.

While dietary protein supplements (PS) are generally safe for healthy adults, the panel emphasizes the importance of using high-quality protein sources and suggests PS use (20-25 g per serving) after intense physical activity when whole foods are not available.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of protein supplements for U.S. Armed Forces personnel: consensus statement. Pasiakos, SM., Austin, KG., Lieberman, HR., et al.[2023]

A 12-week resistance exercise program combined with protein supplementation led to significant increases in lean body mass and improvements in physical performance among 38 healthy older adults, highlighting the efficacy of this combined approach for enhancing muscle health.

Participants who received protein supplementation alongside resistance training experienced a notable reduction in body fat and favorable changes in muscle signaling pathways, which support muscle growth and the body's protective heat shock response.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of a combined bodyweight-based and elastic bands resistance training, with or without protein supplementation, on muscle mass, signaling and heat shock response in healthy older people. Krause, M., Crognale, D., Cogan, K., et al.[2019]

A systematic review of 34 studies found that low skeletal muscle mass is significantly linked to poorer overall survival in pancreatic cancer patients, with a hazards ratio of 1.50, indicating a 50% increased risk of death.

While low muscle quality (measured by muscle attenuation) also correlates with poor overall survival (hazards ratio of 1.32), it does not affect recurrence-free survival, suggesting that muscle mass is a more critical factor for long-term outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of sarcopenia on prognosis of patients with pancreatic cancer: A systematic review and meta-analysis. Gan, H., Lan, J., Bei, H., et al.[2023]

A scoping review of 14 studies indicates that protein and amino acid supplementation can positively impact muscle strength in adult cancer patients, generally aligning with improvements in muscle mass.

Combining energy and protein intake, especially when oral intake is low, leads to more significant gains in muscle strength and mass, although the exact mechanisms behind this effect need further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Impact of Protein Supplementation Targeted at Improving Muscle Mass on Strength in Cancer Patients: A Scoping Review. Zanetti, M., Gortan Cappellari, G., Barazzoni, R., et al.[2021]

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]

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