Fitness in Allogeneic Stem Cell Transplantation

NCT02564458 | Completed DMC

• 2 other identifiers: 15-17051R21CA192127-01A1
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose: The primary hypothesis of this study is that the combination of interval exercise training (IET) as well as motivational accelerometry (MA) delivered both as a 5-12 week intervention that will improve cardiorespiratory fitness in patients preparing to undergo allogeneic hematopoietic cell transplantation (alloHCT). MA is not an established term, but in respect to this study, MA refers to the use of wearable accelerometry paired with regular intervals of physical activity coaching from members of the study staff during the IET training. The study will also look at several secondary endpoints including the association of the intervention with changes in cyclin-dependent kinase inhibitor 2A, multiple tumor suppressor 1 (p16INK4a), and the association of the intervention with changes in symptoms and quality of life before and after transplant. Participants: 60 patients will be randomized into two groups, 30 in the intervention group consisting of both IET and MA, and 30 in the control group applying usual care and use of wearable accelerometry without motivational physical activity coaching. Procedures (methods): Results of this study will inform a randomized, multi-site study of a pre-transplant exercise intervention.

Conditions

Hematopoietic Stem Cell Transplantation

Outcome Measures

Primary Outcomes (1)

• Compare changes in VO2peak after a 5-12 week period of time prior to alloHCT in patients undergoing interval exercise training (IET) and motivational accelerometry (MA) vs patients receiving usual care (controls).

  Patients will undergo a baseline fitness assessment consisting of cardiorespiratory exercise testing using indirect calorimetry on a cycle ergometer (for the assessment of VO2peak).

  5-12 weeks

Secondary Outcomes (2)

• Compare changes in 6 minute walk distance (6MWD) after a 5-12 week period of time prior to alloHCT in patients receiving IET/MA vs controls.

  5-12 weeks

• Compare changes in peripheral blood p16INK4a after a 5-12 week period of time prior to alloHCT in patients receiving IET/MA vs controls.

  5-12 weeks

Other Outcomes (5)

• Compare average steps per day during a 5-12 week period of time prior to alloHCT in patients receiving IET/MA vs. controls

  5-12 weeks

• Compare post-alloHCT average steps per day in patients who received pre-alloHCT IET/MA vs controls.

  Post-alloHCT refers to Day0 (transplant day) through Day+365

• Compare post-alloHCT symptom burden and quality of life in patients who received pre-alloHCT IET/MA vs controls.

  Post-alloHCT refers to Day0 (transplant day) through Day+365

Study Arms (2)

Interval Exercise Training/Motivational Accelerometry (IET/MA)

EXPERIMENTAL

All patients on the experimental arm receive the intervention of 5-12 weeks of pre-transplant IET, motivational accelerometry via the FitBit Surge, pre- and post-fitness assessments, and periodic quality of life and symptom surveys.

Behavioral: Interval Exercise Training/Motivational Accelerometry

Normal Standard of Care (control)

NO INTERVENTION

All patients on the control arm participate in the pre- and post-fitness assessment, are given the FitBit Surge without the motivational component, and are also given periodic quality of life and symptom surveys.

Interventions

Interval Exercise Training/Motivational Accelerometry BEHAVIORAL

During the 5-12 weeks before allogeneic stem cell transplant, the patient will participate in an at home, interval exercise training (IET) program, as well as wear a physical activity tracker, the FitBit Surge, combined with a weekly motivational call, termed Motivational Accelerometry (MA). The combined intervention is referred to as (IET/MA). The first week of the IET program consists of the participants being asked to engage in 30 minutes of aerobic exercise at any intensity for 3-4 days. For weeks two and beyond, patients be asked to undergo 3-4 sessions of IET, consisting of a 5 minute warm-up and five 2-minute intervals, with the goal of reaching 80% MHR, separated by 3 minutes of recovery/light activity in between each interval. Each exercise session is a total of 30 minutes. In addition, each week prior to transplant, the patient will receive a weekly check-in/motivational call from the study staff in order to track progress and motivate the patient to continue participation.

Interval Exercise Training/Motivational Accelerometry (IET/MA)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 75 years of age, inclusive
• Verification of a functioning email address and access to electronic device(s) with the ability to charge and sync the FitBit Surge
• Planned allogeneic stem cell transplant with schedule that accommodates at least a 5 week exercise intervention, but not greater than 12 weeks
• Ability to understand and communicate in English
• Ability to understand and comply with study procedures for the entire length of the study
• Willing and able to provide written informed consent

You may not qualify if:

• Dementia, altered mental status, or psychiatric condition that would prohibit the understanding or rendering of informed consent
• Co-morbid illness that would contraindicate maximal effort exercise testing or participation in regular exercise programming as determined by the treating physician or exercise physiologist
• Concurrent radiation, chemotherapeutic, or investigational therapy other than transplant related therapy
• Concurrent enrollment in LCCC 1404

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead
• National Institutes of Health (NIH): collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27514, United States

Location

Related Publications (21)

• Bevans MF, Mitchell SA, Marden S. The symptom experience in the first 100 days following allogeneic hematopoietic stem cell transplantation (HSCT). Support Care Cancer. 2008 Nov;16(11):1243-54. doi: 10.1007/s00520-008-0420-6. Epub 2008 Mar 6.

  PMID: 18322708 BACKGROUND

• Bevans M. Health-related quality of life following allogeneic hematopoietic stem cell transplantation. Hematology Am Soc Hematol Educ Program. 2010;2010:248-54. doi: 10.1182/asheducation-2010.1.248.

  PMID: 21239801 BACKGROUND

• Khera N, Zeliadt SB, Lee SJ. Economics of hematopoietic cell transplantation. Blood. 2012 Aug 23;120(8):1545-51. doi: 10.1182/blood-2012-05-426783. Epub 2012 Jun 13.

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• Majhail NS, Rizzo JD, Hahn T, Lee SJ, McCarthy PL, Ammi M, Denzen E, Drexler R, Flesch S, James H, Omondi N, Pedersen TL, Murphy E, Pederson K. Pilot study of patient and caregiver out-of-pocket costs of allogeneic hematopoietic cell transplantation. Bone Marrow Transplant. 2013 Jun;48(6):865-71. doi: 10.1038/bmt.2012.248. Epub 2012 Dec 10.

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• Wiskemann J, Dreger P, Schwerdtfeger R, Bondong A, Huber G, Kleindienst N, Ulrich CM, Bohus M. Effects of a partly self-administered exercise program before, during, and after allogeneic stem cell transplantation. Blood. 2011 Mar 3;117(9):2604-13. doi: 10.1182/blood-2010-09-306308. Epub 2010 Dec 29.

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• Wiskemann J, Huber G. Physical exercise as adjuvant therapy for patients undergoing hematopoietic stem cell transplantation. Bone Marrow Transplant. 2008 Feb;41(4):321-9. doi: 10.1038/sj.bmt.1705917. Epub 2007 Nov 19.

  PMID: 18026154 BACKGROUND

• Nytroen K, Rustad LA, Aukrust P, Ueland T, Hallen J, Holm I, Rolid K, Lekva T, Fiane AE, Amlie JP, Aakhus S, Gullestad L. High-intensity interval training improves peak oxygen uptake and muscular exercise capacity in heart transplant recipients. Am J Transplant. 2012 Nov;12(11):3134-42. doi: 10.1111/j.1600-6143.2012.04221.x. Epub 2012 Aug 17.

  PMID: 22900793 BACKGROUND

• Guiraud T, Labrunee M, Gaucher-Cazalis K, Despas F, Meyer P, Bosquet L, Gales C, Vaccaro A, Bousquet M, Galinier M, Senard JM, Pathak A. High-intensity interval exercise improves vagal tone and decreases arrhythmias in chronic heart failure. Med Sci Sports Exerc. 2013 Oct;45(10):1861-7. doi: 10.1249/MSS.0b013e3182967559.

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  PMID: 20195181 BACKGROUND

• Bravata DM, Smith-Spangler C, Sundaram V, Gienger AL, Lin N, Lewis R, Stave CD, Olkin I, Sirard JR. Using pedometers to increase physical activity and improve health: a systematic review. JAMA. 2007 Nov 21;298(19):2296-304. doi: 10.1001/jama.298.19.2296.

  PMID: 18029834 BACKGROUND

• Shephard RJ. Tests of maximum oxygen intake. A critical review. Sports Med. 1984 Mar-Apr;1(2):99-124. doi: 10.2165/00007256-198401020-00002.

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• Jones LW, Eves ND, Haykowsky M, Joy AA, Douglas PS. Cardiorespiratory exercise testing in clinical oncology research: systematic review and practice recommendations. Lancet Oncol. 2008 Aug;9(8):757-65. doi: 10.1016/S1470-2045(08)70195-5.

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• ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available.

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• Liu Y, Sanoff HK, Cho H, Burd CE, Torrice C, Ibrahim JG, Thomas NE, Sharpless NE. Expression of p16(INK4a) in peripheral blood T-cells is a biomarker of human aging. Aging Cell. 2009 Aug;8(4):439-48. doi: 10.1111/j.1474-9726.2009.00489.x. Epub 2009 May 22.

  PMID: 19485966 BACKGROUND

• Sanoff HK, Deal AM, Krishnamurthy J, Torrice C, Dillon P, Sorrentino J, Ibrahim JG, Jolly TA, Williams G, Carey LA, Drobish A, Gordon BB, Alston S, Hurria A, Kleinhans K, Rudolph KL, Sharpless NE, Muss HB. Effect of cytotoxic chemotherapy on markers of molecular age in patients with breast cancer. J Natl Cancer Inst. 2014 Apr;106(4):dju057. doi: 10.1093/jnci/dju057. Epub 2014 Mar 28.

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• Hallal PC, Victora CG. Reliability and validity of the International Physical Activity Questionnaire (IPAQ). Med Sci Sports Exerc. 2004 Mar;36(3):556. doi: 10.1249/01.mss.0000117161.66394.07. No abstract available.

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• Wood WA, Deal AM, Bennett AV, Mitchell SA, Abernethy AP, Basch E, Bailey C, Reeve BB. Comparison of seven-day and repeated 24-hour recall of symptoms in the first 100 days after hematopoietic cell transplantation. J Pain Symptom Manage. 2015 Mar;49(3):513-20. doi: 10.1016/j.jpainsymman.2014.06.011. Epub 2014 Aug 13.

  PMID: 25128608 BACKGROUND

• Schmitz KH, Courneya KS, Matthews C, Demark-Wahnefried W, Galvao DA, Pinto BM, Irwin ML, Wolin KY, Segal RJ, Lucia A, Schneider CM, von Gruenigen VE, Schwartz AL; American College of Sports Medicine. American College of Sports Medicine roundtable on exercise guidelines for cancer survivors. Med Sci Sports Exerc. 2010 Jul;42(7):1409-26. doi: 10.1249/MSS.0b013e3181e0c112.

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• Angadi SS, Mookadam F, Lee CD, Tucker WJ, Haykowsky MJ, Gaesser GA. High-intensity interval training vs. moderate-intensity continuous exercise training in heart failure with preserved ejection fraction: a pilot study. J Appl Physiol (1985). 2015 Sep 15;119(6):753-8. doi: 10.1152/japplphysiol.00518.2014. Epub 2014 Sep 4.

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• Moholdt T, Bekken Vold M, Grimsmo J, Slordahl SA, Wisloff U. Home-based aerobic interval training improves peak oxygen uptake equal to residential cardiac rehabilitation: a randomized, controlled trial. PLoS One. 2012;7(7):e41199. doi: 10.1371/journal.pone.0041199. Epub 2012 Jul 18.

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Related Links

• Pasquini MC, Wang Z. Current use and outcome of hematopoietic stem cell transplantation: CIBMTR Summary Slides, 2011. Slides 3, 18, 21-40.
• National Cancer Institute. Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).
• National Institutes of Health. Patient Reported Outcomes Measurement Information System (PROMIS).

Study Officials

• William A Wood, MD, MPH

  UNC Lineberger Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. William A. Wood, MD, MPH

Study Record Dates

• First Submitted: September 29, 2015
• First Posted: September 30, 2015
• Study Start: September 1, 2015
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: July 6, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)