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Pancreatic AdenocarcinomaREACTNCT02680990

Resilience and Exercise in Advanced Cancer Treatment

A study testing Band Together and Exercise Education in people with Pancreatic Adenocarcinoma and Gastric Adenocarcinoma, run by Milton S. Hershey Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Band Together and Exercise Education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
1 siteUnited States
Study dates
Dec 2015to Jul 2017
Phase
Interventional
Are there results?
None posted in the registry

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

  • 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.

Who cannot join

  • 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.
Show all 9Show fewer
  • Pregnant women.
  • Prisoners
  • Patients screening positive on the Physical Activity Readiness Questionnaire (PAR-Q)

Trial locations and contacts

1 site in 1 country.

United States1 site

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

    Hershey, Pennsylvania, 17033

Other trials in United States

About this study

Official title: Prehabilitation for Patients With Aggressive Gastrointestinal Cancers Undergoing Neoadjuvant Therapy

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.

Read the 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.

Being tested
Band Together, Exercise Education

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Band TogetherBehavioural

    Also called strength training and walking program

    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.

  • Exercise EducationOther

    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.

Study groups in NCT02680990
Study groupRoleWhat they receive
Exercise EducationActive comparatorDistribution of exercise education materials
Receives: Other: Exercise Education
Band TogetherExperimentalA strength-training and walking program with or without an exercise partner throughout neoadjuvant therapy.
Receives: Behavioral: Band Together

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (4)

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

    Potential subjects will be screened using the Physical Activity Readiness Questionnaire; those who may not be ready to begin an exercise program will be ineligible. The proportion of patients who are PAR-Q ineligible will be compared to the proportion of patients who are eligible based on their PAR-Q results. The proportion of patients who are ineligible due to other exclusion criteria will also be compared. All eligible patients who decline to participate in the study will be asked to provide a reason for their decision; the proportion of potential subjects who decline will be compared to the proportion of subjects who do consent and are eligible.

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

  2. Exercise Partner Benefits

    The mean adherence rates (percentage of prescribed sessions completed) for subjects in the intervention group who have an exercise partner participate in ≥50% of their exercise sessions will be compared to those of subjects who have an exercise partner for <50% of their exercise sessions.

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

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

    Subjects will be tested before starting neoadjuvant therapy using a dynamometer and a hanging scale, and then again after completing neoadjuvant therapy, to determine if their grip strength and/or upper body strength have changed from baseline.

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

  4. Assessing the interaction between frailty and the Band Together program

    Frail subjects will be identified using Fried's Frailty Criteria and compared to non-frail subjects using the outcome measures described above.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Feb 2016 (estimated)
  2. Study startDec 2015
  3. Primary completionJul 2017
  4. Study completionJul 2017

Resources

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
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02680990
Sponsor's protocol ID
STUDY00002745
Acronym
REACT
Status last verified
Feb 2018
First submitted
25 Nov 2015
Last updated
28 Feb 2018
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 25519927

  • 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.

    PubMed 24096757

  • 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.

    PubMed 24374288

  • 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.

    PubMed 23064817

Questions about this trial

What is this clinical trial studying?

A study testing Band Together and Exercise Education in people with Pancreatic Adenocarcinoma and Gastric Adenocarcinoma, run by Milton S. Hershey Medical 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 6 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: finished, as of the sponsor's last update on 28 Feb 2018. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Feasibility of Large-Scale Trial: Adherence & Contamination (time frame: Throughout the course of neoadjuvant therapy (on average 10-12 weeks)). 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 NCT02680990, which also lists 4 linked publications.

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 28 Feb 2018.

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