Preoperative Rehabilitation During Neoadjuvant Therapy for Pancreatic Cancer
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|ClinicalTrials.gov Identifier: NCT02295956|
Recruitment Status : Completed
First Posted : November 20, 2014
Last Update Posted : June 12, 2019
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|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Behavioral: Questionnaires Other: Exercise Other: Nutrition Counseling Behavioral: Phone Calls Other: Booklet||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||75 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Preoperative Rehabilitation During Neoadjuvant Therapy for Pancreatic Cancer: A Pilot Study|
|Actual Study Start Date :||February 2, 2015|
|Actual Primary Completion Date :||June 6, 2019|
|Actual Study Completion Date :||June 6, 2019|
Experimental: Home Based Exercise and Nutrition Program
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.
Series of physical and quality of life assessments administered to participants, taking about 20 minutes to complete.
Other Name: Surveys
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.
Other: Nutrition Counseling
Within 7 days after being enrolled on study, participant meets with a dietitian to discuss nutrition.
Behavioral: Phone Calls
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.
Exercise instructional booklet given to all participants describing all exercises.
Other Name: Pamphlet
- 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.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02295956
|United States, Texas|
|University of Houston|
|Houston, Texas, United States, 77004|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Matthew H. Katz, MD||M.D. Anderson Cancer Center|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||M.D. Anderson Cancer Center|
|Other Study ID Numbers:||
NCI-2014-02531 ( Registry Identifier: NCI CTRP )
|First Posted:||November 20, 2014 Key Record Dates|
|Last Update Posted:||June 12, 2019|
|Last Verified:||June 2019|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Resistance exercise bands
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Endocrine System Diseases