Non-chemotherapeutic Interventions for the Improvement of Quality of Life and Immune Function in Patients With Multiple Myeloma

Part of paid clinical trials in Buffalo, New York.

Sponsor
Roswell Park Cancer Institute
Study ID
NCT05312255
Status
Recruiting
Apply to this trial

Conditions

  • Plasma Cell Myeloma
  • Recurrent Plasma Cell Myeloma
  • Refractory Plasma Cell Myeloma
  • Smoldering Plasma Cell Myeloma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Behavioral Intervention — BEHAVIORAL
    Wear a FitBit device and receive prompts for 6 months
  • Beta-Adrenergic Antagonist — DRUG
    Receive beta-blocker regimen as per SOC
  • Propranolol — DRUG
    Given PO
  • Quality-of-Life Assessment — OTHER
    Ancillary studies
  • Questionnaire Administration — OTHER
    Ancillary studies
  • Resistance Training — OTHER
    Undergo strength training for 6 months
  • Short-Term Fasting — OTHER
    Participate in intermittent fasting

Study Details

This clinical trial investigates the effect of non-chemotherapeutic interventions in patients with multiple myeloma or MDS. Non-chemotherapeutic interventions such as physical activity and nutritional interventions (e.g., modifications in diet) have been shown to positively affect the immune system and improve overall quality of life. Another purpose of this study is for researchers to learn how the addition of a beta-blocker (propranolol) to the standard treatment regimen in patients with newly diagnosed multiple myeloma affects immune response and quality of life. A study from the Mayo Clinic looked at multiple myeloma patients who were on a beta-blocker while undergoing chemotherapy and found that the use of a beta-blocker resulted in improved patient survival outcomes. Non-chemotherapeutic treatment options may help decrease symptoms and improve quality of life for patients with multiple myeloma.

Key Dates

Start date
Jun 28, 2022
Status verified
Nov 2025
Primary completion
Jun 28, 2027
Completion
Jun 28, 2027

Study Design

Enrollment
175 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Module A (strength training, behavioral intervention)
    Patients undergo strength training sessions twice weekly supervised by a licensed and specialized personal trainer via the internet (e.g., remote access) for 6 months. Patients also wear a FitBit device and receive prompts via email or text on a cell phone or other electronic device to incrementally increase physical activity over 6 months.
  • Experimental: Module B (intermittent fasting)
    Patients undergo intermittent fasting for 1 month. This consists of restricting all eating to a consecutive 8-hour time period each day followed by 16 consecutive hours of not eating.
  • Experimental: Module C Group I (propranolol)
    Patients receive propranolol PO BID for 3 months.
  • Active Comparator: Module C Group II (propranolol)
    Patients continue receiving beta-blocker regimen as per SOC for 3 months.
  • Experimental: Module D
    MDS Patients undergo strength training for 6 months.

Primary Outcome Measure

Changes in immune cell subsets [ Time Frame: At baseline and at 1 year ]

Locations (1)

FacilityCityStateZIPSite coordinators
Roswell Park Cancer InstituteBuffaloNew York14263
Jens Hillengass
[email protected]
716-845-3863
Jens Hillengass (PRINCIPAL_INVESTIGATOR)

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By research site
Roswell Park Cancer Institute· Buffalo, NY

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