Clinical trial NCT03793907: Strength Training in Improving Pain and Quality of Life in Patients With Multiple Myeloma
Official title: Feasibility of Strength Training and Impact on Pain and Quality of Life in Patients With Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Plasma Cell Myeloma
Lead sponsor: Roswell Park Cancer Institute
Sponsor class: OTHER
First posted: 2019-01-04
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This trial studies how well strength training works in improving bone health, pain, and quality of life in patients with multiple myeloma. Weekly physical activity may improve bone recovery, reduce pain, and increase quality of life in patients with multiple myeloma.

Detailed description: PRIMARY OBJECTIVES:

* I. To assess the feasibility of a 6 month, twice weekly supervised strength training intervention in patients with multiple myeloma. (Cohort 1)
* II. To assess the feasibility of a 6 month behavioral intervention to prompt an increase in weekly physical activity in patient with multiple myeloma. (Cohort 2)

SECONDARY OBJECTIVES:

I. To assess the adherence rate of patients during a 6 month intervention program.

II. To assess the eligibility and recruitment rate for the trial among patients with multiple myeloma.

EXPLORATORY OBJECTIVES:

I. Comparison of disease activity parameters, physical activity level, clinical symptoms, medication, psycho-oncological parameters before, during and after intervention.

II. Determine factors that may influence a persons' willingness to participate in the trial.

III. Investigate "immune fitness" by frequencies and function of immune cell subsets in peripheral blood.

OUTLINE: Patients are assigned to 1 of 2 cohorts.

COHRT 1 (STRENGTH TRAINING): Patients receive a Fitbit to track their physical activity, and complete an in-person personalized and supervised full-body strength training program over 1 hour twice weekly (BID) up to 52 sessions for 6 months.

COHORT 2 (BEHAVIORAL INTERVENTION): Patients receive a Fitbit to track their physical activity, and complete an unsupervised walking program daily at home, increasing physical activity stepwise weekly, for 6 months.

After completion of study, patients are followed up every 3 months for 1 year.

Eligibility criteria: Inclusion Criteria:

* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1
* Have a diagnosis of multiple myeloma
* Show no signs of comorbidities, myeloma symptoms, or treatment side effects that would put them in danger when participating in the study according to the physician's discretion
* Are able to understand and follow assessment and training procedures
* Participant or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure

Exclusion Criteria:

* Current and symptomatic pathological fracture(s) or severely advanced instability of the musculo-skeletal system
* Acute bone instability as assessed by whole body low-dose computed tomography and evaluated by an experienced neuro- and spine surgeon
* Major comorbidities that would cause danger to the patient when participating in the study. Examples are cardiac or pulmonary and infectious diseases that would have a risk of progression if the patient took part in the study
* Unwilling or unable to follow protocol requirements
* Any condition which in the investigator's opinion deems the participant an unsuitable candidate to take part in study intervention (comorbidities, myeloma symptoms, treatment side effects)

Primary outcomes:
measure: Feasibility rate
timeFrame: At 6 months
Secondary outcomes:
measure: Adherence rate (Cohort 1)
timeFrame: At 6 months
measure: Adherence rate (Cohort 2)
timeFrame: At 6 months
Other outcomes:
measure: Differences in lab parameters
timeFrame: Before and after strength training program up to 1 year
measure: Clinical performance
timeFrame: Before and after strength training program up to 1 year
measure: Physical activity level
timeFrame: Before and after strength training program up to 1 year
measure: Pain
timeFrame: Before and after strength training program up to 1 year
measure: Polyneuropathy
timeFrame: Before and after strength training program up to 1 year
measure: Opioid and other drug consumption
timeFrame: Before and after strength training program up to 1 year
measure: Psycho-oncological parameters
timeFrame: Before and after strength training program up to 1 year
measure: Fatigue
timeFrame: Before, during and after strength training program
measure: Reasons why patients do not participate in the trial
timeFrame: Before and after strength training program up to 1 year
measure: "Immune fitness" frequencies and function of immune cell subsets
timeFrame: Before and after strength training program up to 1 year
Locations:
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
Study officials:
affiliation: Roswell Park Cancer Institute
name: Jens Hillengass
role: PRINCIPAL_INVESTIGATOR
References: