Trial Outcomes & Findings for Preoperative Exercise in Pancreatic Cancer (NCT NCT02648880)

NCT ID: NCT02648880

Last Updated: 2021-11-30

Results Overview

Assessment of physical fitness and function. Participants are timed while walking 400 meters at a fast, but safe, pace.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

3 participants

Primary outcome timeframe

Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative

Results posted on

2021-11-30

Participant Flow

Participant milestones

Participant milestones
Measure	Exercise Group Participants will complete an exercise program in addition to standard care. Participants will start the exercise program within four weeks of their diagnosis and decision to undergo neoadjuvant treatment and continue until surgery. Participants will be encouraged to complete three sessions per week for at least eight weeks during neoadjuvant therapy. Exercise intensity, components, and time will be recorded for each exercise session. Participants will schedule their sessions with the exercise specialists administering the program, typically taking place between 8AM and 4PM, Monday through Friday. Exercise program: Individual exercise sessions in this program implement a "whole body" approach and consist of a 10-min cardiovascular warm-up and 50 minutes of cardiovascular endurance, resistance, and flexibility exercises. Target intensity of exercise will be based on the American College of Sports Medicine recommendations for cancer survivors. Prior to the start of exercise sessions, participants will be questioned on significant changes in symptoms or the presence of new symptoms (such as nausea or fever), which will used to modify the exercise session for that day to allow maximum symptom-limited participation. Standard Care: The services that participants receive as standard care include their medical care, symptom control, social worker support, and nutrition. These services are provided by their oncology team.
Overall Study STARTED	3
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Preoperative Exercise in Pancreatic Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Exercise Group n=3 Participants Participants will complete an exercise program in addition to standard care. Participants will start the exercise program within four weeks of their diagnosis and decision to undergo neoadjuvant treatment and continue until surgery. Participants will be encouraged to complete three sessions per week for at least eight weeks during neoadjuvant therapy. Exercise intensity, components, and time will be recorded for each exercise session. Participants will schedule their sessions with the exercise specialists administering the program, typically taking place between 8AM and 4PM, Monday through Friday. Exercise program: Individual exercise sessions in this program implement a "whole body" approach and consist of a 10-min cardiovascular warm-up and 50 minutes of cardiovascular endurance, resistance, and flexibility exercises. Target intensity of exercise will be based on the American College of Sports Medicine recommendations for cancer survivors. Prior to the start of exercise sessions, participants will be questioned on significant changes in symptoms or the presence of new symptoms (such as nausea or fever), which will used to modify the exercise session for that day to allow maximum symptom-limited participation. Standard Care: The services that participants receive as standard care include their medical care, symptom control, social worker support, and nutrition. These services are provided by their oncology team.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative

Population: One participant did not receive surgery and was excluded from the postoperative timepoint.

Assessment of physical fitness and function. Participants are timed while walking 400 meters at a fast, but safe, pace.

Outcome measures

Outcome measures
Measure	Exercise Group n=3 Participants Participants will complete an exercise program in addition to standard care. Participants will start the exercise program within four weeks of their diagnosis and decision to undergo neoadjuvant treatment and continue until surgery. Participants will be encouraged to complete three sessions per week for at least eight weeks during neoadjuvant therapy. Exercise intensity, components, and time will be recorded for each exercise session. Participants will schedule their sessions with the exercise specialists administering the program, typically taking place between 8AM and 4PM, Monday through Friday. Exercise program: Individual exercise sessions in this program implement a "whole body" approach and consist of a 10-min cardiovascular warm-up and 50 minutes of cardiovascular endurance, resistance, and flexibility exercises. Target intensity of exercise will be based on the American College of Sports Medicine recommendations for cancer survivors. Prior to the start of exercise sessions, participants will be questioned on significant changes in symptoms or the presence of new symptoms (such as nausea or fever), which will used to modify the exercise session for that day to allow maximum symptom-limited participation. Standard Care: The services that participants receive as standard care include their medical care, symptom control, social worker support, and nutrition. These services are provided by their oncology team.
Change in 400-meter Walk Time Baseline	212.7 s Interval 211.0 to 214.0
Change in 400-meter Walk Time Pre-operative	194.3 s Interval 188.0 to 205.0
Change in 400-meter Walk Time Postoperative	204 s Interval 195.0 to 213.0

SECONDARY outcome

Timeframe: Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative

Assessment of physical fitness. Dual-energy x-ray absorptiometry (DXA) will assess lean muscle mass and body fat.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative

Participant gait speed will be determined on a 10 meter course for both fast and self-selected paces.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative

Participants are timed as they rise from a chair, walk 3 meters, turn around, and return to the chair and sit.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative

Participants are timed as they ascend and descend one flight of stairs.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative

Participants are timed on how long they can balance on one leg.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative

The number of times a participant can rise from a chair in 30 seconds is counted.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative

The maximum force the participant can produce separately with both hands, assessed by grip dynamometry, is measured.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative

The average step count for a minimum of 3 days over a 7 day period will be assessed with accelerometry.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative

The Colorado Comprehensive Wellness Assessment, a survey, will be administered to assess eight domains of wellness.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative

The Functional Assessment of Cancer Therapy - General Form (FACT-G), a survey, will be administered.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative

Perceived fatigue will be assessed by the Revised Piper Fatigue Scale, a survey.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative

Changes in state and trait anxiety will be assessed with the Spielberger State-Trait Anxiety Index.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative

Changes in perceived stress will be assessed with the Perceived Stress Scale.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative

Heart rate variability will be assessed from electrocardiography (ECG) obtained during a 5 min rest period.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative

Heart rate variability will be assessed from electrocardiography (ECG) obtained during a 5 min rest period, and changes in response to a physiologic challenge (orthostatic stress: chair rise).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative

Heart rate variability will be assessed from electrocardiography (ECG) obtained during a 5 min rest period, and changes in response to a mental challenge (Stroop Task).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative

Heart rate variability will be assessed from electrocardiography (ECG) obtained during a 5 min rest period, and changes in response to a cancer-specific mental challenge (Cancer-Specific Stroop Task).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative

Serum C-reactive protein will be assessed from blood draws.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative

Serum interleukin-6 will be assessed from blood draws.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative

Soluble tumor-necrosis factor receptor 1 will be assessed from blood draws.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative

Serum interleukin-10 will be assessed from blood draws.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 30 days after hospital discharge

At 30 days after discharge from the hospital, a medical record review will be conducted to determine the number of days participants were in the hospital after surgery.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 30 days after hospital discharge

At 30 days after discharge from the hospital, a medical record review will be conducted to determine whether participants were readmitted to the hospital for an unplanned surgical complication in the 30 days following hospital discharge.

Outcome measures

Outcome data not reported

Adverse Events

Exercise Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ryan Marker

University of Colorado

Phone: 3037240819

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place