Resilience and Exercise in Advanced Cancer Treatment

NCT02680990 | Completed DMC

• 1 other identifier: STUDY00002745
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Adenocarcinoma; Gastric Adenocarcinoma; Adenocarcinoma of the Gastroesophageal Junction

Outcome Measures

Primary Outcomes (1)

• Feasibility of Large-Scale Trial: Adherence & Contamination

  The mean adherence rates (percentage of prescribed sessions completed) in the intervention group will be determined based on weekly activity diaries. Activity diaries will be completed by the subject throughout their participation in the study and collected upon the end of participation. The mean contamination rates (completed exercise sessions) in the control group will also be determined based on weekly activity diaries.

  Throughout the course of neoadjuvant therapy (on average 10-12 weeks)

Secondary Outcomes (4)

• Feasibility of a Large-Scale Trial: Eligibility & Willingness to Participate

  Completion of neoadjuvant therapy (on average 10-12 weeks)

• Exercise Partner Benefits

  Completion of neoadjuvant therapy (on average 10-12 weeks)

• Change in grip strength and upper body strength as a result of intervention

  Enrollment in study and completion of neoadjuvant therapy (on average 10-12 weeks)

• Assessing the interaction between frailty and the Band Together program

  Completion of neoadjuvant therapy (on average 10-12 weeks)

Study Arms (2)

Exercise Education

ACTIVE COMPARATOR

Distribution of exercise education materials

Other: Exercise Education

Band Together

EXPERIMENTAL

A strength-training and walking program with or without an exercise partner throughout neoadjuvant therapy.

Behavioral: Band Together

Interventions

Band Together BEHAVIORAL

Band Together is a strength training program utilizing resistance bands with progressively increasing resistance, ranging from 3 to 35 pounds. Sessions are to be completed 3 times a week and involve 3 sets of 6 exercises: 1. chair stands, 2. chest press, 3. shoulder press, 4. arm curls, 5. pulls, and 6. calf raises. In addition, Band Together participants will be asked to work up to a walking goal of 10,000 additional steps per week.

Also known as: strength training and walking program

Band Together

Exercise Education OTHER

Education will consist of counseling by the healthcare provider with supplemental handouts from the American College of Sports Medicine and the National Institute on Aging/ National Institutes of Health.

Exercise Education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

Penn State College of Medicine, Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Related Publications (4)

• 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.

  PMID: 25519927 BACKGROUND

• 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.

  PMID: 24096757 BACKGROUND

• 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.

  PMID: 24374288 BACKGROUND

• 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.

  PMID: 23064817 BACKGROUND

MeSH Terms

Interventions

Resistance Training

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Amanda B Cooper, MD

  Penn State College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Physician

Study Record Dates

• First Submitted: November 25, 2015
• First Posted: February 12, 2016
• Study Start: December 1, 2015
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: February 28, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)