Diet and Exercise After Pancreatic Cancer
Status: | Recruiting |
---|---|
Conditions: | Cancer, Cancer, Pancreatic Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 10/11/2018 |
Start Date: | August 3, 2017 |
End Date: | August 31, 2019 |
Contact: | Laura Q Rogers, MD, MPH |
Email: | rogersl@uab.edu |
Phone: | 205-975-1667 |
Diet and Exercise After Pancreatic Cancer: Clinical and Functional Outcomes (Non Canonical WNT Signaling in Colorectal Cancer)
Determine feasibility of a randomized controlled trial (RCT) in pancreatic cancer patients
comparing the effects of diet alone vs. diet+exercise on functional and clinical outcomes.
comparing the effects of diet alone vs. diet+exercise on functional and clinical outcomes.
Pancreatic cancer causes significant side effects and poorer health-related quality of life
(QOL), as well as a 5-year survival rate of only 6%. Importantly, the reduction in physical
functioning caused by this cancer and its therapies is associated with higher mortality risk.
Although multiple studies in more prevalent cancer types support exercise benefits (e.g.,
improved physical functioning), data cannot be generalized from one cancer type to another.
Little is known about exercise feasibility and benefits in pancreatic cancer patients, and no
data regarding potential mechanistic outcomes that may explain the link between poor physical
performance status and cancer survival have been reported. We will enroll 20 patients with
pancreatic adenocarcinoma who are expected to undergo surgical resection or who are within 3
years of surgical resection, in a pilot project involving a 6-month home-based lifestyle
intervention (diet along versus diet+exercise). Research assessments will be done pre-surgery
(if applicable), post-surgery (and prior to starting the intervention), 3 months, and 6
months post-surgery. Intervention counseling will be delivered using visual communication
(e.g., Skype). Participants will be provided a computer tablet for the intervention with
participants randomized to receive exercise counseling also receiving a fitness bracelet to
facilitate counseling by the certified Cancer Exercise Trainer. Our primary study aim is to
determine feasibility of a randomized controlled trial (RCT) in pancreatic cancer patients
comparing the effects of diet alone with diet+exercise on pancreatic cancer-related
functional and disease outcomes; feasibility measures include recruitment, retention,
intervention adherence, assessment completion, adverse events, and participant satisfaction.
Our secondary study aim is to determine the effect of diet+exercise compared with diet alone
on physical functioning and QOL. Also, we will draw and store blood samples so that
additional funds can be requested to test intervention effects on biomarkers of cancer risk
(e.g., tumor immunity, inflammatory cytokines, etc.). The goal of the study is to advance the
exercise oncology field into an understudied cancer type and develop an intervention that
will improve the survivorship care of pancreatic cancer patients through distance-delivered
counseling methods.
(QOL), as well as a 5-year survival rate of only 6%. Importantly, the reduction in physical
functioning caused by this cancer and its therapies is associated with higher mortality risk.
Although multiple studies in more prevalent cancer types support exercise benefits (e.g.,
improved physical functioning), data cannot be generalized from one cancer type to another.
Little is known about exercise feasibility and benefits in pancreatic cancer patients, and no
data regarding potential mechanistic outcomes that may explain the link between poor physical
performance status and cancer survival have been reported. We will enroll 20 patients with
pancreatic adenocarcinoma who are expected to undergo surgical resection or who are within 3
years of surgical resection, in a pilot project involving a 6-month home-based lifestyle
intervention (diet along versus diet+exercise). Research assessments will be done pre-surgery
(if applicable), post-surgery (and prior to starting the intervention), 3 months, and 6
months post-surgery. Intervention counseling will be delivered using visual communication
(e.g., Skype). Participants will be provided a computer tablet for the intervention with
participants randomized to receive exercise counseling also receiving a fitness bracelet to
facilitate counseling by the certified Cancer Exercise Trainer. Our primary study aim is to
determine feasibility of a randomized controlled trial (RCT) in pancreatic cancer patients
comparing the effects of diet alone with diet+exercise on pancreatic cancer-related
functional and disease outcomes; feasibility measures include recruitment, retention,
intervention adherence, assessment completion, adverse events, and participant satisfaction.
Our secondary study aim is to determine the effect of diet+exercise compared with diet alone
on physical functioning and QOL. Also, we will draw and store blood samples so that
additional funds can be requested to test intervention effects on biomarkers of cancer risk
(e.g., tumor immunity, inflammatory cytokines, etc.). The goal of the study is to advance the
exercise oncology field into an understudied cancer type and develop an intervention that
will improve the survivorship care of pancreatic cancer patients through distance-delivered
counseling methods.
Inclusion Criteria:
- adult 18 years of age or older with resectable pancreatic adenocarcinoma for whom
surgery is planned (includes "borderline resectable" if deemed appropriate by surgical
investigators) or has occurred within the past 3 years
- English speaking
- Eastern Cooperative Technology Group (ECOG) performance status of 0,1 or 2.
- able to ambulate without assistance
- able to obtain medical clearance
Exclusion Criteria:
- pancreatic cancer recurrence
- dementia or organic brain syndrome
- severe emotional distress
- medical, psychological or social characteristic that would interfere with the ability
to fully participate in program activities and assessments
- another diagnosis of cancer in the past 5 years (not including skin or cervical cancer
in situ).
- oncologist refuses to allow screening for possible study participation
- current participation in another exercise trial
We found this trial at
1
site
1720 2nd Ave S
Birmingham, Alabama 35233
Birmingham, Alabama 35233
(205) 934-4011
Phone: 205-975-1247
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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