Other Disorders of Glucose Regulation and Pancreatic Internal SecretionNCT03187951
PancFit: Multimodal Exercise During Preoperative Therapy for Pancreatic Cancer
A study testing Questionnaires, Nutritional Questionnaire and Nutritional Counseling and Booklet in people with Other Disorders of Glucose Regulation and Pancreatic Internal Secretion and Pancreatic Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
Any time the words "you," "your," "I," or "me" appear, it is meant to apply to the potential participant. The goal of this clinical research study is to learn if regular exercise and behavioral skills training can help to improve physical activity in patients with pancreatic cancer who are scheduled to receive… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Other Disorders of Glucose Regulation and Pancreatic Internal Secretion, Pancreatic Cancer
- What is being tested?
- Questionnaires, Nutritional Questionnaire and Nutritional Counseling and Booklet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jun 2017to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 cancer of any type, biopsy-proven
- Scheduled to receive preoperative therapy (chemotherapy, radiation or chemoradiation) either on- or off-protocol.
- Anticipated to undergo pancreatectomy in >/= 6 weeks from enrollment
- Able to understand the description of the study and willing to participate
- Able to understand the exercise program
- Able to maintain daily exercise logs
- Telephone or email access and agreement to engage with the research personnel via phone or email
- Meet all screening requirements.
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
Show all 9Show fewer
- Recurrent cancer following prior resection
- Neuroendocrine cancer
- Completed preoperative therapy and are on their presurgical rest period.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: PancFit: Multimodal Exercise During Preoperative Therapy for Pancreatic Cancer: A Randomized Trial Testing Effects on Fitness, Health-Related Quality of Life, and Tumor Vasculature
Any time the words "you," "your," "I," or "me" appear, it is meant to apply to the potential participant.
The goal of this clinical research study is to learn if regular exercise and behavioral skills training can help to improve physical activity in patients with pancreatic cancer who are scheduled to receive chemotherapy and/or radiation before standard-of-care surgery.
This is an investigational study.
Up to 128 participants will be enrolled on this study. All will take part at MD Anderson.
Read the detailed description
Study Groups:
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study arms. This is done because no one knows if one study arm is better than, the same, or worse than the other group.
If you are in Arm A, you will not take part in a structured exercise program. If you are in Arm B, you will take part in a structured exercise program and behavioral skills training as described below.
Length of Study:
You will continue to take part in this study for up to 7 months after your scheduled standard-of-care surgery. However, if intolerable side effects occur or the disease appears to get worse, the study staff will decide if continuing the exercise program is in your best interest.
Study Visits:
At your baseline visit, after you complete chemotherapy and/or radiation, 3-6 weeks after surgery, and then 3-7 months after surgery:
- You will complete 4 questionnaires about your physical abilities, motivation, and quality of life. They should take about 25 minutes total to complete.
- Your hand grip strength will be measured using a hand-held machine
- Your arm strength will be measured using an arm curl test. You will be given a small weight (about 5-8 pounds) and asked to perform as many bicep curls as you can for 30 seconds.
- You will be asked to rise from a chair without using your arms to push off.
- You will complete a 6-minute walk test to see how far you can walk in 6 minutes.
- You will complete a nutritional questionnaire and receive nutritional counseling. The questionnaire will ask about your diet and any recent weight loss. It should take about 5 minutes to complete. After you complete the questionnaire, you will receive educational materials and personalized counseling based on your answers.
- If you are in Arm B, you will receive behavioral skills training to teach you ways to monitor your health, set goals, and reward yourself. It should take about 15 minutes to complete.
- At the baseline visit, you will be given a Fitbit Charge 2 activity tracker to wear during the study. This is a small device designed to record your physical activity and sleep during the study. This device will allow you to monitor your own physical activity and sleep and may help you achieve your goals. You can keep the Fitbit after the study is over.
If you are in Arm B, one (1) time each week for the first 4 weeks and then every 2 weeks after that, a member of the study staff will contact you by phone for behavioral skills training and to see how you are doing. These calls should last about 15 minutes.
For 2 weeks during each phase of chemotherapy and/or radiation you receive, you will wear a small activity monitor on an elastic band. This will be worn in addition to your Fitbit.
Exercise Programs:
ARM A:
If you are in Arm A, you will be encouraged to remain active during chemotherapy and/or radiation, but you will not receive instruction about aerobic or strengthening exercises. You will receive a booklet that contains a stretching guide with full-body stretches and safety.
ARM B:
If you are in Arm B, you will be asked to complete up to 30 minutes of moderate-intensity aerobic exercise (such as brisk walking, stationary cycling, and/or elliptical or stair stepping machines) for at least 5 days each week.
You will also complete strength training exercises at least 2 times per week. You will complete 1 set of 10-15 repetitions for each of the 8 exercises that you are taught. Over time, the amount of resistance, repetitions, and/or sets may increase or decrease based on your strength. You will be given 5 different resistance tubes to complete these exercises, but you may use free-weights or machines if you prefer.
You should complete warm up exercises and 5 minutes of stretching before and after strength training.
You must keep a daily activity log to document your exercises.
- Conditions
- Other Disorders of Glucose Regulation and Pancreatic Internal Secretion, Pancreatic Cancer
- Being tested
- Questionnaires, Nutritional Questionnaire and Nutritional Counseling, Booklet, Aerobic Exercise and Strength Training Exercises, Phone Calls
- Keywords
- Other disorders of glucose regulation and pancreatic internal secretion, Pancreatic cancer, Questionnaires, Surveys, Nutritional Questionnaire, Nutritional Counseling, Booklet, Pamphlet, Educational materials, Aerobic Exercise, Strength Training Exercises, Physical Assessments, Walk Test
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesBehavioural
Also called Surveys
Participants complete 4 questionnaires about physical abilities, motivation, and quality of life They should take about 25 minutes total to complete.
Nutritional Questionnaire and Nutritional CounselingBehavioural
Participants complete a nutritional questionnaire and receive nutritional counseling. It should take about 5 minutes to complete. Participants receive educational materials and personalized counseling based on participant's answers.
BookletOther
Also called Pamphlet, Educational materials
Participants receive a booklet that contains a stretching guide with full-body stretches and safety.
Aerobic Exercise and Strength Training ExercisesBehavioural
Participants complete up to 30 minutes of moderate-intensity aerobic exercise (such as brisk walking, stationary cycling, and/or elliptical or stair stepping machines) for at least 5 days each week. Participants complete strength training exercises at least 2 times per week.
Phone CallsBehavioural
Participants contacted by phone by member of study staff one (1) time each week for the first 4 weeks, and then every 2 weeks after that for behavioral skills training and to see how participant is doing. These calls should last about 15 minutes.
Physical AssessmentsBehavioural
After completion of chemotherapy and/or radiation, 3-6 weeks after surgery, and then 3-7 months after surgery: Participant's hand grip strength measured using a hand-held machine. Participants arm strength measured using an arm curl test. Participants asked to rise from a chair without using their arms to push off. Participants complete a 6-minute walk test to see how far participant can walk in 6 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Standard of Care (SOC) | Experimental | After completion of chemotherapy and/or radiation, 3-6 weeks after surgery, and then 3-7 months after surgery: Participants complete 4 questionnaires about physical abilities, motivation, and quality of life. Participant's hand grip strength measured. Participants arm strength measured using an arm curl test. Participants asked to rise from a chair without using their arms to push off. Participants complete a 6-minute walk test to see how far participant can walk in 6 minutes. Participants complete a nutritional questionnaire and receive nutritional counseling. Participants receive educational materials and personalized counseling based on participant's answers.
Participants encouraged to remain active during chemotherapy and/or radiation. Participants receive a booklet that contains a stretching guide with full-body stretches and safety. Receives: Behavioral: Questionnaires; Behavioral: Nutritional Questionnaire and Nutritional Counseling; Other: Booklet; Behavioral: Physical Assessments |
| Arm B: Multi-Modal Exercise and Nutrition Program (MMENP) | Experimental | After completion of chemotherapy and/or radiation, 3-6 weeks after surgery, then 3-7 months after surgery: Participants complete 4 questionnaires about physical abilities, motivation, and quality of life. Participant's hand grip strength measured. Participants arm strength measured. Participants asked to rise from a chair without using their arms to push off. Participants complete a 6-minute walk test to see how far participant can walk in 6 minutes. Participants complete a nutritional questionnaire and receive nutritional counseling. Participants receive educational materials and personalized counseling based on participant's answers.
Participants complete moderate-intensity aerobic exercise 5 days each week. Participants complete strength training exercises 2 times per week.
Participants contacted by phone by member of study staff 1 time each week for the first 4 weeks, and then every 2 weeks after that for behavioral skills training and to see how participant is doing. Receives: Behavioral: Questionnaires; Behavioral: Nutritional Questionnaire and Nutritional Counseling; Behavioral: Aerobic Exercise and Strength Training Exercises; Behavioral: Phone Calls; Behavioral: Physical Assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 6 Minute Walk Test (6MWT)
Primary endpoint is the change in 6MWT distance, measured in meters, between the time at which preoperative therapy is administered (T0) and the time at which it ends (T1).
Measured: Change compared from baseline to date surgery is scheduled
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2017
- Study start13 Jun 2017
- Primary completion31 Dec 2022
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Other Disorders of Glucose Regulation and Pancreatic Internal SecretionStudies 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 152 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
- NCT03187951
- Sponsor's protocol ID
- 2017-0198
- Other IDs
- NCI-2018-01183
- Status last verified
- May 2026
- First submitted
- 13 Jun 2017
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ngo-Huang AT, Parker NH, Xiao L, Schadler KL, Petzel MQB, Prakash LR, Kim MP, Tzeng CD, Lee JE, Ikoma N, Wolff RA, Javle MM, Koay EJ, Pant SD, Folloder JP, Wang X, Cotto AM, Ju YR, Garg N, Wang H, Bruera ED, Basen-Engquist KM, Katz MHG. Effects of a Pragmatic Home-based Exercise Program Concurrent With Neoadjuvant Therapy on Physical Function of Patients With Pancreatic Cancer: The PancFit Randomized Clinical Trial. Ann Surg. 2023 Jul 1;278(1):22-30. doi: 10.1097/SLA.0000000000005878. Epub 2023 Apr 7.
PubMed 37026453
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PancFit: Multimodal Exercise During Preoperative Therapy for Pancreatic Cancer: A Randomized Trial Testing Effects on Fitness, Health-Related Quality of Life, and Tumor Vasculature
- ClinicalTrials.gov ID
- NCT03187951
- Acronym / sponsor ID
- 2017-0198
- Conditions
- Other Disorders of Glucose Regulation and Pancreatic Internal Secretion, Pancreatic Cancer
- Keywords
- Other disorders of glucose regulation and pancreatic internal secretion, Pancreatic cancer, Questionnaires, Surveys, Nutritional Questionnaire, Nutritional Counseling, Booklet, Pamphlet
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 152 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 13 Jun 2017 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 15 Jun 2017 (actual)
- 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.
Any time the words "you," "your," "I," or "me" appear, it is meant to apply to the potential participant.
The goal of this clinical research study is to learn if regular exercise and behavioral skills training can help to improve physical activity in patients with pancreatic cancer who are scheduled to receive chemotherapy and/or radiation before standard-of-care surgery.
This is an investigational study.
Up to 128 participants will be enrolled on this study. All will take part at MD Anderson.
Detailed description
Study Groups:
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study arms. This is done because no one knows if one study arm is better than, the same, or worse than the other group.
If you are in Arm A, you will not take part in a structured exercise program. If you are in Arm B, you will take part in a structured exercise program and behavioral skills training as described below.
Length of Study:
You will continue to take part in this study for up to 7 months after your scheduled standard-of-care surgery. However, if intolerable side effects occur or the disease appears to get worse, the study staff will decide if continuing the exercise program is in your best interest.
Study Visits:
At your baseline visit, after you complete chemotherapy and/or radiation, 3-6 weeks after surgery, and then 3-7 months after surgery:
- You will complete 4 questionnaires about your physical abilities, motivation, and quality of life. They should take about 25 minutes total to complete.
- Your hand grip strength will be measured using a hand-held machine
- Your arm strength will be measured using an arm curl test. You will be given a small weight (about 5-8 pounds) and asked to perform as many bicep curls as you can for 30 seconds.
- You will be asked to rise from a chair without using your arms to push off.
- You will complete a 6-minute walk test to see how far you can walk in 6 minutes.
- You will complete a nutritional questionnaire and receive nutritional counseling. The questionnaire will ask about your diet and any recent weight loss. It should take about 5 minutes to complete. After you complete the questionnaire, you will receive educational materials and personalized counseling based on your answers.
- If you are in Arm B, you will receive behavioral skills training to teach you ways to monitor your health, set goals, and reward yourself. It should take about 15 minutes to complete.
- At the baseline visit, you will be given a Fitbit Charge 2 activity tracker to wear during the study. This is a small device designed to record your physical activity and sleep during the study. This device will allow you to monitor your own physical activity and sleep and may help you achieve your goals. You can keep the Fitbit after the study is over.
If you are in Arm B, one (1) time each week for the first 4 weeks and then every 2 weeks after that, a member of the study staff will contact you by phone for behavioral skills training and to see how you are doing. These calls should last about 15 minutes.
For 2 weeks during each phase of chemotherapy and/or radiation you receive, you will wear a small activity monitor on an elastic band. This will be worn in addition to your Fitbit.
Exercise Programs:
ARM A:
If you are in Arm A, you will be encouraged to remain active during chemotherapy and/or radiation, but you will not receive instruction about aerobic or strengthening exercises. You will receive a booklet that contains a stretching guide with full-body stretches and safety.
ARM B:
If you are in Arm B, you will be asked to complete up to 30 minutes of moderate-intensity aerobic exercise (such as brisk walking, stationary cycling, and/or elliptical or stair stepping machines) for at least 5 days each week.
You will also complete strength training exercises at least 2 times per week. You will complete 1 set of 10-15 repetitions for each of the 8 exercises that you are taught. Over time, the amount of resistance, repetitions, and/or sets may increase or decrease based on your strength. You will be given 5 different resistance tubes to complete these exercises, but you may use free-weights or machines if you prefer.
You should complete warm up exercises and 5 minutes of stretching before and after strength training.
You must keep a daily activity log to document your exercises.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: Standard of Care (SOC) | Experimental | Behavioral: Questionnaires, Behavioral: Nutritional Questionnaire and Nutritional Counseling, Other: Booklet, Behavioral: Physical AssessmentsAfter completion of chemotherapy and/or radiation, 3-6 weeks after surgery, and then 3-7 months after surgery: Participants complete 4 questionnaires about physical abilities, motivation, and quality of life. Participant's hand grip strength measured. Participants arm strength measured using an arm curl test. Participants asked to rise from a chair without using their arms to push off. Participants complete a 6-minute walk test to see how far participant can walk in 6 minutes. Participants complete a nutritional questionnaire and receive nutritional counseling. Participants receive educational materials and personalized counseling based on participant's answers. Participants encouraged to remain active during chemotherapy and/or radiation. Participants receive a booklet that contains a stretching guide with full-body stretches and safety. |
| Arm B: Multi-Modal Exercise and Nutrition Program (MMENP) | Experimental | Behavioral: Questionnaires, Behavioral: Nutritional Questionnaire and Nutritional Counseling, Behavioral: Aerobic Exercise and Strength Training Exercises, Behavioral: Phone Calls, Behavioral: Physical AssessmentsAfter completion of chemotherapy and/or radiation, 3-6 weeks after surgery, then 3-7 months after surgery: Participants complete 4 questionnaires about physical abilities, motivation, and quality of life. Participant's hand grip strength measured. Participants arm strength measured. Participants asked to rise from a chair without using their arms to push off. Participants complete a 6-minute walk test to see how far participant can walk in 6 minutes. Participants complete a nutritional questionnaire and receive nutritional counseling. Participants receive educational materials and personalized counseling based on participant's answers. Participants complete moderate-intensity aerobic exercise 5 days each week. Participants complete strength training exercises 2 times per week. Participants contacted by phone by member of study staff 1 time each week for the first 4 weeks, and then every 2 weeks after that for behavioral skills training and to see how participant is doing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Pancreatic cancer of any type, biopsy-proven
- Scheduled to receive preoperative therapy (chemotherapy, radiation or chemoradiation) either on- or off-protocol.
- Anticipated to undergo pancreatectomy in >/= 6 weeks from enrollment
- Able to understand the description of the study and willing to participate
- Able to understand the exercise program
Key exclusion criteria (9 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: SurveysParticipants complete 4 questionnaires about physical abilities, motivation, and quality of life They should take about 25 minutes total to complete. | Behavioural | Arm A: Standard of Care (SOC), Arm B: Multi-Modal Exercise and Nutrition Program (MMENP) |
| Nutritional Questionnaire and Nutritional CounselingParticipants complete a nutritional questionnaire and receive nutritional counseling. It should take about 5 minutes to complete. Participants receive educational materials and personalized counseling based on participant's answers. | Behavioural | Arm A: Standard of Care (SOC), Arm B: Multi-Modal Exercise and Nutrition Program (MMENP) |
| BookletAlso: Pamphlet, Educational materialsParticipants receive a booklet that contains a stretching guide with full-body stretches and safety. | Other | Arm A: Standard of Care (SOC) |
| Aerobic Exercise and Strength Training ExercisesParticipants complete up to 30 minutes of moderate-intensity aerobic exercise (such as brisk walking, stationary cycling, and/or elliptical or stair stepping machines) for at least 5 days each week. Participants complete strength training exercises at least 2 times per week. | Behavioural | Arm B: Multi-Modal Exercise and Nutrition Program (MMENP) |
| Phone CallsParticipants contacted by phone by member of study staff one (1) time each week for the first 4 weeks, and then every 2 weeks after that for behavioral skills training and to see how participant is doing. These calls should last about 15 minutes. | Behavioural | Arm B: Multi-Modal Exercise and Nutrition Program (MMENP) |
| Physical AssessmentsAfter completion of chemotherapy and/or radiation, 3-6 weeks after surgery, and then 3-7 months after surgery: Participant's hand grip strength measured using a hand-held machine. Participants arm strength measured using an arm curl test. Participants asked to rise from a chair without using their arms to push off. Participants complete a 6-minute walk test to see how far participant can walk in 6 minutes. | Behavioural | Arm A: Standard of Care (SOC), Arm B: Multi-Modal Exercise and Nutrition Program (MMENP) |
Primary outcome
Change in 6 Minute Walk Test (6MWT)
Time frame: Change compared from baseline to date surgery is scheduled
Primary endpoint is the change in 6MWT distance, measured in meters, between the time at which preoperative therapy is administered (T0) and the time at which it ends (T1).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Derived from this study: PubMed 37026453Ngo-Huang AT, Parker NH, Xiao L, Schadler KL, Petzel MQB, Prakash LR, Kim MP, Tzeng CD, Lee JE, Ikoma N, Wolff RA, Javle MM, Koay EJ, Pant SD, Folloder JP, Wang X, Cotto AM, Ju YR, Garg N, Wang H, Bruera ED, Basen-Engquist KM, Katz MHG. Effects of a Pragmatic Home-based Exercise Program Concurrent With Neoadjuvant Therapy on Physical Function of Patients With Pancreatic Cancer: The PancFit Randomized Clinical Trial. Ann Surg. 2023 Jul 1;278(1):22-30. doi: 10.1097/SLA.0000000000005878. Epub 2023 Apr 7.
- MD Anderson Cancer CenterLink provided by the sponsor.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaires, Nutritional Questionnaire and Nutritional Counseling and Booklet in people with Other Disorders of Glucose Regulation and Pancreatic Internal Secretion and Pancreatic Cancer, run by M.D. Anderson Cancer Center at 1 site 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 8 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Change in 6 Minute Walk Test (6MWT) (time frame: Change compared from baseline to date surgery is scheduled). 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 NCT03187951, which also lists 1 linked publication.
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 20 May 2026.