Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT05056805
Study type Interventional
Source M.D. Anderson Cancer Center
Contact
Status Recruiting
Phase N/A
Start date March 4, 2021
Completion date December 31, 2022

See also
  Status Clinical Trial Phase
Recruiting NCT05059444 - ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation
Recruiting NCT03673423 - Evaluation of the Interobserver Agreement on the Resectability Status of Patients With a Pancreatic Cancer
Active, not recruiting NCT02495896 - Recombinant EphB4-HSA Fusion Protein With Standard Chemotherapy Regimens in Treating Patients With Advanced or Metastatic Solid Tumors Phase 1
Completed NCT03054987 - Endoscopic Ultrasound and Endoscopic Retrograde Cholangiopancreatography for Malignant Distal Biliary Obstruction N/A
Terminated NCT02345460 - Preoperative Folfirinox for Resectable Pancreatic Adenocarcinoma - A Phase II Study Phase 2
Recruiting NCT02072616 - Detection of Circulating Tumor Cells for the Diagnostic of Pancreatic Adenocarcinoma. Phase 3
Completed NCT02174887 - Biological Effect of Nab-paclitaxel Combined to Gemcitabine in Metastatic Pancreatic Cancer Phase 1
Completed NCT01959672 - Combination Chemotherapy With or Without Oregovomab Followed by Stereotactic Body Radiation Therapy and Nelfinavir Mesylate in Treating Patients With Locally Advanced Pancreatic Cancer Phase 2
Recruiting NCT03703063 - Alternative Neoadjuvant Chemotherapy in Resectable and Borderline Resectable Pancreatic Cancer Phase 1
Suspended NCT04077372 - Assessment of a Serious Illness Conversation Guide (SICG) in Advanced Gastro-Intestinal Cancers N/A
Recruiting NCT03073785 - Hypofractionated Stereotactic Body Radiation Therapy and Fluorouracil or Capecitabine With or Without Zoledronic Acid in Treating Patients With Locally Advanced Pancreatic Cancer Phase 2
Active, not recruiting NCT03665441 - Study of Eryaspase in Combination With Chemotherapy Versus Chemotherapy Alone as 2nd-Line Treatment in PAC Phase 3
Recruiting NCT04627246 - Personalized Vaccine With SOC Chemo Followed by Nivo in Pancreatic Cancer Phase 1
Recruiting NCT04119362 - PARAGON Platform for Outcome, Quality of Life, and Translational Research on Pancreatic Cancer
Recruiting NCT03105921 - Irreversible Electroporation (NanoKnife) for the Treatment of Pancreatic Adenocarcinoma N/A
Recruiting NCT05000294 - Atezolizumab Plus Tivozanib in Immunologically Cold Tumor Types Phase 1/Phase 2
Recruiting NCT02446093 - Neoadjuvant GMCI Plus Chemoradiation for Advanced Non-Metastatic Pancreatic Adenocarcinoma Phase 2
Withdrawn NCT02592395 - Study of FOLFIRINOX Electrochemotherapy in the Treatment of Pancreatic Adenocarcinoma Phase 1
Completed NCT01699698 - Pancreatic Juice Diagnosis From Duodenum N/A
Terminated NCT01419002 - Study to Evaluate if Neoadjuvant Radiotherapy Improves Recurrence Free Survival in Pancreatic Head Cancer Phase 3