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Remote Exercise and Nutritional Prehabilitation for Pancreatic Cancer

ConditionPancreatic Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorH. Lee Moffitt Cancer Center and Research Institute

About 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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 years or older

Biopsy-proven pancreatic ductal adenocarcinoma (PDAC), borderline resectable at diagnosis

Eastern Cooperative Oncology Group (ECOG) performance status 0-2

Undergoing neoadjuvant chemotherapy with treatment plan including chemoradiation therapy and surgical resection

Disqualifiers

Regular engagement in RT (2x/week targeting all major muscle groups)

Screen failure for exercise safety based on PAR-Q

Underlying unstable cardiac or pulmonary disease or symptomatic cardiac disease

Recent fracture or acute musculoskeletal injury that precludes ability to participate in RT

Trial design

Design model

Parallel

Treatments tested in this trial

  • Physical Activity

    Behavioral

    Each participant will receive a Fitbit device with instruction and encouragement to self-monitor physical activity using step counts.

  • Nutrition Counseling

    Behavioral

    Participants will receive nutritional counseling with a registered dietician.

  • Resistance Training

    Behavioral

    Participants will engage in progressive, full-body resistance training based on American College of Sports Medicine (ACSM) guidelines.

Treatment groups

26 Participants
are divided into 2 treatment groups
Group A: Physical activity, nutrition counseling and monitoring group (PA/N)Experimental treatment 2 interventions
Group B: Physical activity, tele-resistance training, nutrition counseling and monitoring group (RT/N)Experimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Feasibility and acceptability of PA/N and RT/N programs

The number of participants who complete T1 and T0 measures.

Time frame
Up to 16 weeks

Secondary outcomes

1

Examine exploratory outcomes and clinical characteristics

The number of participants who demonstrate improvements in exploratory outcome measures.

Time frame
Up to 16 weeks
2

Compare clinical and treatment outcomes

Chi-Square testing will be used to determine if there's a significant difference in outcomes between the treatment group and a usual care comparison group.

Time frame
Up to 16 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

H. Lee Moffitt Cancer Center and Research Institute

Lead sponsor

Source ClinicalTrials.gov
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