An Exercise and Nutrition Monitoring Intervention (Pt Pal) for the Improvement of Strength in Patients With Pancreatic or Stomach Cancer Receiving Chemoradiation Therapy Before Surgery, SurgeryStrong Study

October 26, 2022 updated by: M.D. Anderson Cancer Center

"SurgeryStrong". Preoperative Strength Exercise and Nutrition Program in Patients Completing Neoadjuvant Chemoradiation Therapy for Pancreatic and Gastric Cancer: A Randomized Trial Testing Effects on Strength, Fitness, Health-Related Quality of Life, and Perioperative Outcomes

This clinical trial studies the effectiveness of a home-based exercise and nutrition monitoring program called Pt Pal in improving strength in patients with pancreatic or stomach cancer receiving chemoradiation therapy before surgery. Pt Pal is a mobile health technology used to facilitate communication between the care team and the patient/caregiver, by allowing the care team to send from their web-portal, exercise routines, activities of daily living, diet recommendations, surveys and educational material to the patient/caregiver's mobile device. The Pt Pal application (app) then captures the patient/caregiver activity adherence data and reports those results back to the care team. The Pt Pal program may help improve overall strength in patients undergoing surgery for pancreatic and stomach cancer relative to standard care.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVE:

I. In patients with pancreatic and gastric cancer undergoing preoperative chemoradiation and potentially curative resection, compare the change in dynamic lower muscle strength as measured by the 1 repetition maximum (1-RM) leg press between the time of enrollment and prior to resection in those who: a. Are offered aerobic exercise encouragement prior to surgery b. Are offered aerobic exercise encouragement, nutrition monitoring, and a structured strength exercise program prior to surgery.

SECONDARY OBJECTIVES:

I. To compare the change in dynamic muscle strength as measured by the 1-RM for the chest press, seated row, and leg extension.

II. To compare upper and lower body muscle endurance as defined by the maximal number of repetitions performed at 70% of the pre-exercise 1-RM for the chest and leg press.

III. To compare the change in the six minute walk test (6MWT) distance of patients between the time of enrollment and prior to resection.

IV. To compare physical function (patient-reported based on the Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function Short Form and objectively based on grip strength) between groups.

V. To compare the quality of life (Functional Assessment of Cancer Therapy, patients with hepatobiliary cancer [FACT-Hep]) between groups.

VI. To compare exercise motivation (Behavioral Regulation in Exercise Questionnaire [BREQ]-3) between groups.

VII. To compare anthropometric measures (e.g., weight, skeletal muscle, visceral fat and subcutaneous fat) using SliceOMatic software from usual care computed tomography (CT) scans between groups.

VIII. To assess the incidence of perioperative adverse events that occur within 90 days between groups (Accordion score).

IX. To compare changes in physical activity between the time of enrollment and immediately prior to surgery based on the Modified Godin-Shephard Leisure Time Physical Activity Questionnaire.

X. To evaluate feasibility of patient completion of 24-hour recall via Automated Self-Administered 24-Hour Dietary Assessment Tool (ASA-24).

XI. To measure adoption of nutrition recommendations as compared to baseline. XII. To compare adherence to nutrition recommendations within and between groups.

XIII. To compare "usual care" laboratory studies including those that are indicators of nutritional status within and between groups.

XIV. To compare the vascular and tumor structure, and immune cell infiltration in tumors between patients in different groups.

XV. To compare potential biomarkers of angiogenesis and inflammation that correlate with exercise, disease pathology, and/or clinical and functional outcomes.

XVI. To store in a research bank any remaining tissue or blood (collected for the purposes of the above objectives) for the possibility of future analysis.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A: Patients are encouraged to complete at least 30 minutes of moderate intensity aerobic exercise, at least 3 times per week. Patients receive nutrition consultation with a registered dietitian and monitor dietary intake. Aerobic exercises and nutrition are tracked in the Pt Pal app.

ARM B: Patients complete at least 30 minutes of moderate intensity aerobic exercise (such as brisk walking or stationary bike cycling) at least 3 times per week. Patients also complete strength exercises with resistance tubes/bands at least 2 times per week, with at least 2 sets of 8-15 repetitions of the exercises taught. Patients receive nutrition consultation with a registered dietitian and monitor dietary intake. Patients also consume a high protein snack/meal/shake (15-25 grams) within 1 hour after any strengthening exercises. Exercise activities and nutrition are tracked in the Pt Pal app.

After randomization, patients are followed up at 4-6 weeks.

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Pancreatic or gastric adenocarcinoma, biopsy-proven
  • Have completed or are within 2 weeks of completion of preoperative chemoradiotherapy either on- or off-protocol
  • Anticipated to undergo potentially curative resection in 4-6 weeks from enrollment
  • Able to understand the description of the study and willing to participate
  • Able to understand the exercise program
  • Able to independently maintain daily exercise logs via Pt Pal -iOS, Android or desktop web browser on their own personal device
  • Telephone or email access and agreement to engage with the research personnel via phone or email
  • Meet all screening requirements, including physician clearance
  • >= age 18

Exclusion Criteria:

  • Non-English speaking
  • Has participated in moderate to high intensity strengthening exercises at least two times per week within the past four weeks prior to enrollment
  • Unable to complete the baseline assessment questionnaires or functional assessments
  • Underlying unstable cardiac or pulmonary disease or symptomatic cardiac disease (New York Heart Association functional class III or IV)
  • Recent fracture or acute musculoskeletal injury that precludes the ability to weight bear fully on all 4 limbs in order to participate in an exercise intervention
  • Numeric pain rating scale of >= 7 out of 10
  • Myopathic or rheumatologic disease that impacts physical function
  • Recurrent cancer following prior resection
  • < age 18

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm A (aerobic exercise, nutritional recommendation)
Patients are encouraged to complete at least 30 minutes of moderate intensity aerobic exercise, at least 3 times per week. Patients receive nutrition consultation with a registered dietitian and monitor dietary intake. Aerobic exercises and nutrition are tracked in the Pt Pal app
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Other: Questionnaire Administration
Ancillary studies
Other: Aerobic Exercise
Receive aerobic exercise encouragement
Other Names:
  • Aerobic Activity
Other: Nutritional Intervention
Receive nutritional consultation and guidelines
Experimental: Arm B (aerobic, strength exercise, nutritional recommendation)
Patients complete at least 30 minutes of moderate intensity aerobic exercise (such as brisk walking or stationary bike cycling) at least 3 times per week. Patients also complete strength exercises with resistance tubes/bands at least 2 times per week, with at least 2 sets of 8-15 repetitions of the exercises taught. Patients receive nutrition consultation with a registered dietitian and monitor dietary intake. Patients also consume a high protein snack/meal/shake (15-25 grams) within 1 hour after any strengthening exercises. Exercise activities and nutrition are tracked in the Pt Pal app.
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Other: Questionnaire Administration
Ancillary studies
Other: Aerobic Exercise
Receive aerobic exercise encouragement
Other Names:
  • Aerobic Activity
Other: Nutritional Intervention
Receive nutritional consultation and guidelines
Other: Dietary Intervention
Consume high protein snack/meal/shake
Other Names:
  • Dietary Modification
  • intervention, dietary
  • Nutrition Intervention
  • Nutrition Interventions
  • Nutritional Interventions
Other: Resistance Training
Complete strengthening exercise
Other Names:
  • Strength Training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in dynamic lower muscle strength
Time Frame: through study completion, an average of a year
through study completion, an average of a year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Investigators

  • Principal Investigator: Matthew H Katz, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 4, 2021

Primary Completion (Actual)

September 8, 2022

Study Completion (Actual)

September 8, 2022

Study Registration Dates

First Submitted

September 7, 2021

First Submitted That Met QC Criteria

September 15, 2021

First Posted (Actual)

September 27, 2021

Study Record Updates

Last Update Posted (Actual)

October 28, 2022

Last Update Submitted That Met QC Criteria

October 26, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-0026 (Other Identifier: M D Anderson Cancer Center)
  • NCI-2021-02655 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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