Clinical trial NCT02564458: Fitness in Allogeneic Stem Cell Transplantation
Official title: Fitness in Allogeneic Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hematopoietic Stem Cell Transplantation
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Cancer Institute (NCI)
First posted: 2015-09-30
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: The investigator team for the current protocol has recently completed a single-arm pilot protocol (LCCC 1311) of a 6-week home-based unsupervised IET program (goal of three IET sessions per week, 65%-95% Max Heart Rate \[MHR\]) in patients planning to undergo alloHCT. In our study, participants preparing to undergo alloHCT experienced an average 3.8ml/kg\*min improvement in peak volume of oxygen consumed (VO2peak) from pre to post-intervention. Patients in LCCC 1311 wore FitBit accelerometers throughout the study period.

The primary purpose of the current randomized controlled trial is to determine, in patients preparing to undergo alloHCT, whether an intervention comprised of interval exercise training and motivational accelerometry (IET/MA) will improve cardiorespiratory fitness more than the control group who receives usual care and an accelerometer without motivational physical activity coaching. The study will also look at several secondary endpoints including the association of the intervention with changes in p16INK4a, and the association of the intervention with changes in symptoms and quality of life before and after transplant.

This randomized controlled trial will include 60 patients preparing to undergo alloHCT (30 in the intervention group, 30 in the control group). We plan to analyze the effect of IET/MA on VO2peak. Subjects will be recruited after their transplant teams have determined that they will undergo alloHCT within the subsequent 5-12 weeks. Following recruitment, patients will undergo baseline fitness assessments consisting of cardiorespiratory exercise testing using indirect calorimetry on a cycle ergometry (for the assessment of VO2peak), 6 minute walk distance testing, and baseline physical activity, symptom and quality of life questionnaires. Participants randomized to the IET/MA group will then receive an individualized IET/MA prescription for a duration of at least 5 weeks, up until the time of admission for alloHCT or 12 weeks from the initiation of IET/MA, whichever occurs first. The mode of exercise can be walking, jogging, running, cycling, elliptical, stair climbing, or a combination of these, and will be performed unsupervised at home. For the first week, participants will be asked to engage in 30 minutes of aerobic exercise at any intensity for 3-4 days. For weeks two and beyond, participants will 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. Fitness assessments will be completed at the end of the intervention period, at the time of admission for alloHCT. Based on the improvement in VO2peak seen in the pre-alloHCT patient population in LCCC 1311, the current study is powered to detect a 3.8ml/kg\*min VO2peak improvement in the intervention group relative to the control group.

All participants in both groups will be provided with a FitBit Surge accelerometer. Participants in the intervention group will also receive weekly motivation from a study team member to achieve a 10% week over week improvement in average steps/day. Participants in the control group will not receive this physical activity coaching. Participants will continue to wear the accelerometers after the intervention and until 1 year following alloHCT. Participants in both groups will have blood drawn for p16INK4a levels before and after the IET intervention. Participants in both groups will also complete symptom and quality of life questionnaires before the intervention and periodically throughout the year following alloHCT (please see study plan and time and events tables).

Eligibility criteria: Inclusion Criteria:

* 18 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: 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).
timeFrame: 5-12 weeks
Secondary outcomes:
measure: 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.
timeFrame: 5-12 weeks
measure: Compare changes in peripheral blood p16INK4a after a 5-12 week period of time prior to alloHCT in patients receiving IET/MA vs controls.
timeFrame: 5-12 weeks
Other outcomes:
measure: Compare average steps per day during a 5-12 week period of time prior to alloHCT in patients receiving IET/MA vs. controls
timeFrame: 5-12 weeks
measure: Compare post-alloHCT average steps per day in patients who received pre-alloHCT IET/MA vs controls.
timeFrame: Post-alloHCT refers to Day0 (transplant day) through Day+365
measure: Compare post-alloHCT symptom burden and quality of life in patients who received pre-alloHCT IET/MA vs controls.
timeFrame: Post-alloHCT refers to Day0 (transplant day) through Day+365
measure: Compare post-alloHCT days alive and out of the hospital within the first 100 days post-transplant in patients who received pre-alloHCT IET/MA vs controls.
timeFrame: Post-alloHCT refers to the initial discharge day after allo-HCT through the first 100 days out of the hospital and/or alive, whichever is the shorter duration.
measure: Compare post-alloHCT survival in patients who received pre-alloHCT IET/MA vs controls.
timeFrame: Post-alloHCT refers to Day0 (transplant day) through Day+365
Locations:
city: Chapel Hill
country: United States
facility: Lineberger Comprehensive Cancer Center
state: North Carolina
Study officials:
affiliation: UNC Lineberger Comprehensive Cancer Center
name: William A Wood, MD, MPH
role: PRINCIPAL_INVESTIGATOR
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