Pancreatic CancerEarly Phase 1NCT02295956
Preoperative Rehabilitation During Neoadjuvant Therapy for Pancreatic Cancer
A Early Phase 1 study testing Questionnaires, Exercise and Nutrition Counseling in people with Pancreatic Cancer, run by M.D. Anderson Cancer Center at 2 sites in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Questionnaires, Exercise and Nutrition Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 2 sitesUnited States
- Study dates
- 2 Feb 2015to 6 Jun 2019
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pancreatic adenocarcinoma, biopsy-proven or suspected.
- Scheduled for intended pancreatectomy, > 4 weeks until planned resection.
- Scheduled for neoadjuvant chemotherapy and/or chemoradiation for pancreatic cancer.
- Able to understand the description of the study and willing to participate.
- Able to understand the exercise intervention and able to maintain a daily exercise log.
- Participant must have telephone access and agree to engage with telephone access with the research personnel.
Who cannot join
- Non-English speaking.
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Houston
Houston, Texas, 77004
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
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).
Read the detailed description
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.
- Conditions
- Pancreatic Cancer
- Being tested
- Questionnaires, Exercise, Nutrition Counseling, Phone Calls, Booklet
- Keywords
- Pancreatic Cancer, Pancreatic adenocarcinoma, Preoperative therapy, Questionnaires, Surveys, Exercises, Stretching, Walking, Nutrition counseling, Resistance exercise bands, Phone calls, Booklet, Pamphlet
- Medical subject headings
- Pancreatic Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesBehavioural
Also called Surveys
Series of physical and quality of life assessments administered to participants, taking about 20 minutes to complete.
ExerciseOther
Participants instructed to perform resistance/strengthening exercises for 30 minutes two times each week. Participants to walk 20-30 minutes at least 3 times a week. Participants issued a set of 3 resistance exercise bands with which the exercises can be performed.
Nutrition CounselingOther
Within 7 days after being enrolled on study, participant meets with a dietitian to discuss nutrition.
Phone CallsBehavioural
Participants receive phone calls from study staff every 2 weeks for 6 weeks to check for adherence, and if they are having any side effects from the exercise.
BookletOther
Also called Pamphlet
Exercise instructional booklet given to all participants describing all exercises.
| Study group | Role | What they receive |
|---|---|---|
| Home Based Exercise and Nutrition Program | Experimental | Series of physical and quality of life assessments administered to participants, taking about 20 minutes to complete. Participants instructed to perform resistance/strengthening exercises for 30 minutes two times each week. Exercise instructional booklet given to all participants describing all exercises. Participants to walk 20-30 minutes at least 3 times a week. Nutrition program discussed with participants. Participants receive phone calls from study staff every 2 weeks for 6 weeks to check for adherence, and if they are having any side effects from the exercise. Receives: Behavioral: Questionnaires; Other: Exercise; Other: Nutrition Counseling; Behavioral: Phone Calls; Other: Booklet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Prehabilitation Program Among Pancreatic Patients
Feasibility established if > 60% of patients are adherent. Prehabilitation program deemed feasible if 60% or more of participants complete at least 60% of the weekly 150-minute combined walking and strengthening exercises during the 6-week preoperative period.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2014 (estimated)
- Study start2 Feb 2015
- Primary completion6 Jun 2019
- Study completion6 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthew H. Katz, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02295956
- Sponsor's protocol ID
- 2014-0702
- Other IDs
- NCI-2014-02531
- Status last verified
- Jun 2019
- First submitted
- 18 Nov 2014
- Last updated
- 12 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kurz E, Hirsch CA, Dalton T, Shadaloey SA, Khodadadi-Jamayran A, Miller G, Pareek S, Rajaei H, Mohindroo C, Baydogan S, Ngo-Huang A, Parker N, Katz MHG, Petzel M, Vucic E, McAllister F, Schadler K, Winograd R, Bar-Sagi D. Exercise-induced engagement of the IL-15/IL-15Ralpha axis promotes anti-tumor immunity in pancreatic cancer. Cancer Cell. 2022 Jul 11;40(7):720-737.e5. doi: 10.1016/j.ccell.2022.05.006. Epub 2022 Jun 2.
PubMed 35660135Ngo-Huang A, Parker NH, Bruera E, Lee RE, Simpson R, O'Connor DP, Petzel MQB, Fontillas RC, Schadler K, Xiao L, Wang X, Fogelman D, Sahai SK, Lee JE, Basen-Engquist K, Katz MHG. Home-Based Exercise Prehabilitation During Preoperative Treatment for Pancreatic Cancer Is Associated With Improvement in Physical Function and Quality of Life. Integr Cancer Ther. 2019 Jan-Dec;18:1534735419894061. doi: 10.1177/1534735419894061.
PubMed 31858837Parker NH, Lee RE, O'Connor DP, Ngo-Huang A, Petzel MQB, Schadler K, Wang X, Xiao L, Fogelman D, Simpson R, Fleming JB, Lee JE, Tzeng CD, Sahai SK, Basen-Engquist K, Katz MHG. Supports and Barriers to Home-Based Physical Activity During Preoperative Treatment of Pancreatic Cancer: A Mixed-Methods Study. J Phys Act Health. 2019 Dec 1;16(12):1113-1122. doi: 10.1123/jpah.2019-0027. Epub 2019 Oct 7.
PubMed 31592772
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Rehabilitation During Neoadjuvant Therapy for Pancreatic Cancer: A Pilot Study
- ClinicalTrials.gov ID
- NCT02295956
- Acronym / sponsor ID
- 2014-0702
- Conditions
- Pancreatic Cancer
- Keywords
- Pancreatic Cancer, Pancreatic adenocarcinoma, Preoperative therapy, Questionnaires, Surveys, Exercises, Stretching, Walking
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 2 Feb 2015 (actual)
- Primary completion
- 6 Jun 2019 (actual)
- Study completion
- 6 Jun 2019 (actual)
- First posted
- 20 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Home Based Exercise and Nutrition Program | Experimental | Behavioral: Questionnaires, Other: Exercise, Other: Nutrition Counseling, Behavioral: Phone Calls, Other: BookletSeries of physical and quality of life assessments administered to participants, taking about 20 minutes to complete. Participants instructed to perform resistance/strengthening exercises for 30 minutes two times each week. Exercise instructional booklet given to all participants describing all exercises. Participants to walk 20-30 minutes at least 3 times a week. Nutrition program discussed with participants. Participants receive phone calls from study staff every 2 weeks for 6 weeks to check for adherence, and if they are having any side effects from the exercise. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Pancreatic adenocarcinoma, biopsy-proven or suspected.
- Scheduled for intended pancreatectomy, > 4 weeks until planned resection.
- Scheduled for neoadjuvant chemotherapy and/or chemoradiation for pancreatic cancer.
- Able to understand the description of the study and willing to participate.
- Able to understand the exercise intervention and able to maintain a daily exercise log.
Key exclusion criteria (6 listed)
- Non-English speaking.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnairesAlso: SurveysSeries of physical and quality of life assessments administered to participants, taking about 20 minutes to complete. | Behavioural | Home Based Exercise and Nutrition Program |
| ExerciseParticipants instructed to perform resistance/strengthening exercises for 30 minutes two times each week. Participants to walk 20-30 minutes at least 3 times a week. Participants issued a set of 3 resistance exercise bands with which the exercises can be performed. | Other | Home Based Exercise and Nutrition Program |
| Nutrition CounselingWithin 7 days after being enrolled on study, participant meets with a dietitian to discuss nutrition. | Other | Home Based Exercise and Nutrition Program |
| Phone CallsParticipants receive phone calls from study staff every 2 weeks for 6 weeks to check for adherence, and if they are having any side effects from the exercise. | Behavioural | Home Based Exercise and Nutrition Program |
| BookletAlso: PamphletExercise instructional booklet given to all participants describing all exercises. | Other | Home Based Exercise and Nutrition Program |
Primary outcome
Feasibility of Prehabilitation Program Among Pancreatic Patients
Time frame: 6 weeks
Feasibility established if > 60% of patients are adherent. Prehabilitation program deemed feasible if 60% or more of participants complete at least 60% of the weekly 150-minute combined walking and strengthening exercises during the 6-week preoperative period.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2019.
- Derived from this study: PubMed 35660135Kurz E, Hirsch CA, Dalton T, Shadaloey SA, Khodadadi-Jamayran A, Miller G, Pareek S, Rajaei H, Mohindroo C, Baydogan S, Ngo-Huang A, Parker N, Katz MHG, Petzel M, Vucic E, McAllister F, Schadler K, Winograd R, Bar-Sagi D. Exercise-induced engagement of the IL-15/IL-15Ralpha axis promotes anti-tumor immunity in pancreatic cancer. Cancer Cell. 2022 Jul 11;40(7):720-737.e5. doi: 10.1016/j.ccell.2022.05.006. Epub 2022 Jun 2.
- Derived from this study: PubMed 31858837Ngo-Huang A, Parker NH, Bruera E, Lee RE, Simpson R, O'Connor DP, Petzel MQB, Fontillas RC, Schadler K, Xiao L, Wang X, Fogelman D, Sahai SK, Lee JE, Basen-Engquist K, Katz MHG. Home-Based Exercise Prehabilitation During Preoperative Treatment for Pancreatic Cancer Is Associated With Improvement in Physical Function and Quality of Life. Integr Cancer Ther. 2019 Jan-Dec;18:1534735419894061. doi: 10.1177/1534735419894061.
- Derived from this study: PubMed 31592772Parker NH, Lee RE, O'Connor DP, Ngo-Huang A, Petzel MQB, Schadler K, Wang X, Xiao L, Fogelman D, Simpson R, Fleming JB, Lee JE, Tzeng CD, Sahai SK, Basen-Engquist K, Katz MHG. Supports and Barriers to Home-Based Physical Activity During Preoperative Treatment of Pancreatic Cancer: A Mixed-Methods Study. J Phys Act Health. 2019 Dec 1;16(12):1113-1122. doi: 10.1123/jpah.2019-0027. Epub 2019 Oct 7.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew H. Katz, MD principal investigator
M.D. Anderson Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Questionnaires, Exercise and Nutrition Counseling in people with Pancreatic Cancer, run by M.D. Anderson Cancer Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Prehabilitation Program Among Pancreatic Patients (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02295956, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2019.