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Strength Training in Improving Quality of Life in Patients With Multiple Myeloma

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ClinicalTrials.gov Identifier: NCT03793907
Recruitment Status : Not yet recruiting
First Posted : January 4, 2019
Last Update Posted : February 20, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Roswell Park Cancer Institute

Brief Summary:
This trial studies how well strength training works in improving 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.

Condition or disease Intervention/treatment Phase
Plasma Cell Myeloma Other: Control Group Other: Questionnaire Administration Other: Strenght Training Not Applicable

Detailed Description:

PRIMARY OBJECTIVES:

I. To assess the feasibility of a 6 month, twice weekly supervised strength training or a control intervention in patients with multiple myeloma.

SECONDARY OBJECTIVES:

I. To assess the adherence rate of the two groups (supervised strength training versus control) during the 6 month intervention programs.

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, body composition and immune status between the intervention and control group.

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

III. Compare the bone density (acquired by dual energy x-ray absorptiometry [DEXA] scan) before and after intervention.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients complete strength training over 1 hour twice weekly for 6 months.

ARM II: Patients receive standard of care.

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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Feasibility of Strength Training and Impact on Bone Health, Pain, and Quality of Life in Patients With Multiple Myeloma
Estimated Study Start Date : March 31, 2019
Estimated Primary Completion Date : October 11, 2021
Estimated Study Completion Date : October 11, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arm Intervention/treatment
Experimental: Arm I (strength training)
Patients complete strength training over 1 hour twice weekly for 6 months.
Other: Questionnaire Administration
Ancillary studies

Other: Strenght Training
Twice a week strength training for 6 months
Other Name: Resistance Training

Active Comparator: Arm II (standard of care)
Patients receive standard of care.
Other: Control Group
To perform activities of daily living according to the discretion of an orthopedic or neurosurgeon.
Other Names:
  • standard of care
  • standard therapy

Other: Questionnaire Administration
Ancillary studies




Primary Outcome Measures :
  1. Feasibility rate [ Time Frame: At 6 months ]
    Will be defined as the proportion of randomized patients in the intervention group who are still on study at the end of 6 months as compared to the control group.


Secondary Outcome Measures :
  1. Adherence rate [ Time Frame: At 6 months ]
    Will be defined as the proportion of patients remaining on study at 6 months who complete >= 80% of the intervention activities. In the control group adherence will be assessed according to patients taking part in the diagnostic procedures.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03793907


Locations
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United States, New York
Roswell Park Cancer Institute Not yet recruiting
Buffalo, New York, United States, 14263
Contact: Jens Hillengass    716-845-3221    Jens.Hillengass@roswellpark.org   
Principal Investigator: Jens Hillengass         
Sponsors and Collaborators
Roswell Park Cancer Institute
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Jens Hillengass Roswell Park Cancer Institute

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Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT03793907     History of Changes
Other Study ID Numbers: i 70118
NCI-2018-03192 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
i 70118 ( Other Identifier: Roswell Park Cancer Institute )
P30CA016056 ( U.S. NIH Grant/Contract )
First Posted: January 4, 2019    Key Record Dates
Last Update Posted: February 20, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases