Clinical trial NCT02680990: Resilience and Exercise in Advanced Cancer Treatment
Official title: Prehabilitation for Patients With Aggressive Gastrointestinal Cancers Undergoing Neoadjuvant Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatic Adenocarcinoma
Gastric Adenocarcinoma
Adenocarcinoma of the Gastroesophageal Junction
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2016-02-12
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a pilot study to evaluate the feasibility of, adherence to, and early efficacy of Band Together, a strength-training and walking program (intervention arm) vs. education on the benefits of exercise (control arm) in patients with aggressive gastrointestinal (GI) malignancies (gastric, gastroesophageal, and pancreatic cancer) undergoing neoadjuvant therapy.

Detailed description: A growing body of evidence suggests host resilience (lack of frailty, skeletal muscle reserve, etc.) may impact early healing, recovery following neoadjuvant therapy and surgery, and long-term cancer-free survival. It is well-recognized that resilience is enhanced in individuals with proper diet, sleep habits, and exercise. However, it is unknown whether such resilience can be enhanced by training programs initiated at the time of cancer diagnosis. Although exercise interventions may contribute to these improvements, it is unknown how willing and able these patients are to comply with an exercise regimen during the neoadjuvant therapy period. The aim of this study, therefore, is to evaluate compliance with and the efficacy of Band Together, an exercise program combining strength-training and aerobic exercise, in patients with aggressive GI malignancies undergoing neoadjuvant therapy.

Eligibility criteria: Inclusion Criteria:

1. Age 18 years or older
2. New diagnosis of potentially resectable or borderline resectable pancreatic adenocarcinoma, gastric adenocarcinoma, or adenocarcinoma of the gastroesophageal junction.
3. Patients must be evaluated at the Penn State Hershey Medical Center prior to receiving neoadjuvant chemotherapy or chemoradiation.
4. Patients must be deemed appropriate for neoadjuvant therapy by their treating health care providers.
5. The ability to speak and read English.
6. The ability to provide informed consent.

Exclusion Criteria:

1. Angina (stable or unstable)
2. Paraplegia or quadriplegia
3. Joint or muscle conditions that prevent the patient from being able to grip and or lift resistance bands.
4. Patients who have already started neoadjuvant chemotherapy at other institutions.
5. Presence of metastatic disease.
6. Gastric or pancreatic histologies other than adenocarcinoma.
7. Pregnant women.
8. Prisoners
9. Patients screening positive on the Physical Activity Readiness Questionnaire (PAR-Q)

Primary outcomes:
measure: Feasibility of Large-Scale Trial: Adherence & Contamination
timeFrame: Throughout the course of neoadjuvant therapy (on average 10-12 weeks)
Secondary outcomes:
measure: Feasibility of a Large-Scale Trial: Eligibility & Willingness to Participate
timeFrame: Completion of neoadjuvant therapy (on average 10-12 weeks)
measure: Exercise Partner Benefits
timeFrame: Completion of neoadjuvant therapy (on average 10-12 weeks)
measure: Change in grip strength and upper body strength as a result of intervention
timeFrame: Enrollment in study and completion of neoadjuvant therapy (on average 10-12 weeks)
measure: Assessing the interaction between frailty and the Band Together program
timeFrame: Completion of neoadjuvant therapy (on average 10-12 weeks)
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: Penn State College of Medicine
name: Amanda B Cooper, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cooper AB, Slack R, Fogelman D, Holmes HM, Petzel M, Parker N, Balachandran A, Garg N, Ngo-Huang A, Varadhachary G, Evans DB, Lee JE, Aloia T, Conrad C, Vauthey JN, Fleming JB, Katz MH. Characterization of Anthropometric Changes that Occur During Neoadjuvant Therapy for Potentially Resectable Pancreatic Cancer. Ann Surg Oncol. 2015 Jul;22(7):2416-23. doi: 10.1245/s10434-014-4285-2. Epub 2014 Dec 18.
citation: Dale W, Hemmerich J, Kamm A, Posner MC, Matthews JB, Rothman R, Palakodeti A, Roggin KK. Geriatric assessment improves prediction of surgical outcomes in older adults undergoing pancreaticoduodenectomy: a prospective cohort study. Ann Surg. 2014 May;259(5):960-5. doi: 10.1097/SLA.0000000000000226.
citation: van de Rest O, van der Zwaluw NL, Tieland M, Adam JJ, Hiddink GJ, van Loon LJ, de Groot LC. Effect of resistance-type exercise training with or without protein supplementation on cognitive functioning in frail and pre-frail elderly: secondary analysis of a randomized, double-blind, placebo-controlled trial. Mech Ageing Dev. 2014 Mar-Apr;136-137:85-93. doi: 10.1016/j.mad.2013.12.005. Epub 2013 Dec 27.
citation: Bollwein J, Diekmann R, Kaiser MJ, Bauer JM, Uter W, Sieber CC, Volkert D. Dietary quality is related to frailty in community-dwelling older adults. J Gerontol A Biol Sci Med Sci. 2013 Apr;68(4):483-9. doi: 10.1093/gerona/gls204. Epub 2012 Oct 12.