Resistance Training Intervention to Improve Physical Function in Patients With Pancreatic Cancer Receiving Combination Chemotherapy or Have Undergone Surgery, PancStrength Study

Pancreatic Adenocarcinoma Clinical Trial

Official title: PancStrength: Safety, Feasibility, and Acceptability of a Tele-Exercise Resistance Training Intervention During Pancreatic Cancer Treatment

Status Active, not recruiting

Clinical Trial Summary

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.

Clinical Trial Description

PRIMARY OBJECTIVE:

I. Evaluate the safety of a progressive, home-based, tele-exercise resistance training (tele-RT) intervention in patients undergoing first line FOLFIRINOX chemotherapy for advanced pancreatic ductal adenocarcinoma (PDAC) (Study 1) and in survivors who have undergone pancreatic cancer resection (Study 2).

SECONDARY OBJECTIVES:

I. Evaluate the feasibility and acceptability of the tele-RT intervention.

II. Evaluate changes in the following exploratory outcome measures over the course of first-line FOLFIRINOX for advanced PDAC and associations between resistance training (RT) volumes and their changes:

IIa. Muscular strength IIb. Muscular endurance IIc. Body composition (skeletal muscle mass) IId. Aerobic fitness IIe. Self-reported physical activity IIf. Self-reported physical functioning IIg. Fatigue IIh. Peripheral neuropathy IIi. Health-related quality of life (QOL) IIj. Completion of intended chemotherapy dose (Among patients who are undergoing chemotherapy; all participants in Study 1 and some in Study 2) IIk. Exercise motivation IIl. Exercise self-efficacy IIm. Social support for exercise IIn. Reduction or change in FOLFIRINOX treatment plan III. Evaluate cancer care providers' (treating physicians and other clinical personnel) perspectives regarding the feasibility and acceptability of the tele-RT intervention for their patients.

OUTLINE:

STUDY 1: During the first 2-3 months of first line FOLFIRINOX chemotherapy, patients complete at least 4 tele-RT sessions over 30-45 minutes each, every 2 weeks. Patients receive handouts created by MD Anderson Cancer Center (MDACC) clinical dietitians including individualized recommendations for daily protein intake and information about healthy protein supplementation during chemotherapy. Patient may also attend a visit with a registered dietician (or delegate dietician) per standard of care, if they have renal insufficiency, special dietary needs, or difficulty adhering to protein recommendations.

STUDY 2: After standard of care surgical resection, patients complete at least 4 tele-RT sessions over 30-45 minutes each, every 2 weeks for 2-3 months. Patients receive handouts created by MDACC clinical dietitians including individualized recommendations for daily protein intake and information about healthy protein supplementation during chemotherapy. Patient may also attend a visit with a registered dietician (or delegate dietician) per standard of care, if they have renal insufficiency, special dietary needs, or difficulty adhering to protein recommendations. ;

Related Conditions & MeSH terms

• Adenocarcinoma
• Advanced Pancreatic Adenocarcinoma
• Pancreatic Adenocarcinoma
• Pancreatic Neoplasms
• Stage III Pancreatic Cancer AJCC v8
• Stage IV Pancreatic Cancer AJCC v8

• NCT number: NCT04837118
• Study type: Interventional
• Source: M.D. Anderson Cancer Center
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 15, 2021
• Completion date: December 31, 2026