Pancreatic Cancer Clinical Trial
Official title:
Preoperative Rehabilitation During Neoadjuvant Therapy for Pancreatic Cancer: A Pilot Study
The goal of this research study is to learn if it is possible to start a home-based exercise and nutrition program for patients with pancreatic cancer or who may have pancreatic cancer before surgery (pre-operative rehabilitation, also known as prehabilitation).
Study Procedures:
If you are found to be eligible to take part in this study, you will be asked to complete
additional questionnaires about your physical activity and quality of life. It will take
about 20 minutes to complete all of the questionnaires in this study. Your strength and
walking speed will also be checked using a hand-held grip test, having you stand from a
sitting position five times, and a 6 minute walking test.
The exercise regimen will then be discussed with you. It will include a resistance/
strengthening program and a walking program.
You will receive a booklet and an instructional video describing all of the exercises, a set
of resistance tubes and accessories you need to perform all exercises, and a pedometer to
count your daily steps. Also, a specialist in rehabilitation along with other study staff
will teach you the stretching and strengthening exercises. An MD Anderson rehabilitation
doctor will oversee all of this.
Resistance/Strengthening Program:
You will be instructed to perform resistance/strengthening exercises for 30 minutes at least
two times each week.
The exercises used in this study are designed to strengthen your muscles. Strengthening
certain muscle groups will help with upper body control and balance, which the study staff
believes may help with mobility before and after surgery. Also, strengthening the shoulder,
back, and leg muscles are important for activities such as getting into and out of bed, which
is important after surgeries such as pancreas surgery.
You will be instructed to perform any 8 (out of 19) strengthening exercises for a total of 30
minutes. You will be issued a set of 3 resistance exercise tubes with which the exercises can
be performed. The strengthening exercises consist of seated and standing weight-bearing
exercises. You will perform 3 sets of 8-12 repetitions each of each exercise. When you are
able to perform 3 sets of 12 repetitions of an exercise, you will move up to the next level
of resistance (different color tube).
Before the strengthening exercises, you will do a series of 4 standing warm-up exercises that
will help with balance.
You will record the date, resistance (color of resistance tube used), number of repetitions
and sets, and how hard a session of resistance exercises felt for you. You will also record
the total time spent on the strengthening program after each exercise session
You will be encouraged to complete an additional 5 minutes of stretching following the
exercises. You will be provided with a handout demonstrating upper body, back, and leg
stretches to help prevent soreness.
Walking Program:
The walking program will consist of walking briskly for 20-30 minutes at least 3 times each
week. If you are unable to tolerate walking at a brisk speed, you will be instructed to walk
at a slower pace. You will be given a pedometer and will be instructed to record the number
of steps taken each day in addition to the total time spent during each walking session.
Nutrition:
Within 7 days after being enrolled on this study, you will meet with a dietitian to discuss
your nutrition. You will be then be provided with recommendations for calorie, protein, and
fluid intake, tools for tracking intake (such as a diet log), as well as goals for weight
depending on your treatment/recovery. You will also be instructed to eat a high protein
snack/meal/shake within 1 hour after each strengthening session.
Phone Calls:
You will be called every 2 weeks and asked if you are following the exercise and nutrition
programs and if you are having any side effects from the exercise (such as pain or difficulty
breathing). You will also be asked which resistance band you are using. Each phone call will
take about 10-15 minutes.
Length of Study:
You will use the exercise programs during your entire pre-operative period, including during
the time you are on other treatments before surgery. In addition, you will continue the
exercise program and evaluations for up to 4 months after you have had surgery. If you have a
side effect or the disease gets worse, the study staff will decide if continuing the exercise
program is in your best interest.
This is an investigational study.
Up to 70 participants will be enrolled on this study. All will take part at MD Anderson.
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