Loading clinical trials...
Loading clinical trials...
Improving Host Factors in Patients With Monoclonal Gammopathies and Other Hematologic Disorders
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.
PRIMARY OBJECTIVES: I. To assess the impact of different lifestyle and low side effect interventions (exercise, nutrition, stress effects reduction) on immune markers in patients with monoclonal plasma cell and other hematologic disorders. SECONDARY OBJECTIVES: I. To assess the impact of different lifestyle and low side effect interventions (exercise, nutrition) on bone turnover parameters, body composition, the microbiome and physical fitness in patients with monoclonal plasma cell and other hematologic disorders. II. To assess the impact of different lifestyle and low side effect interventions (exercise, nutrition, stress effect reduction) on parameters of stress, mental health and quality of life in patients with monoclonal plasma cell and other hematologic disorders. OUTLINE: Patients are assigned to Module A, B C or D. (MDS patients will only be assigned in Module D) MODULE A: 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. MODULE B: 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. MODULE C: Patients are assigned to group 1 (are not currently taking beta-blockers) or group 2 (current taking beta-blockers). GROUP I: Patients receive propranolol orally (PO) twice daily (BID) for 3 months. GROUP II: Patients continue receiving beta-blocker regimen as per standard of care (SOC) for 3 months. MODULE D: Patients will receive resistance training twice a week for 6 months. After completion of the study interventions, patients in module A are followed every 3 months for 1 year. Patients in module B are followed at 3 and 5 months. Patients in module C are followed for 3 months.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Roswell Park Cancer Institute
Buffalo, New York, United States
Start Date
June 28, 2022
Primary Completion Date
June 28, 2027
Completion Date
June 28, 2027
Last Updated
December 1, 2025
175
ESTIMATED participants
Behavioral Intervention
BEHAVIORAL
Beta-Adrenergic Antagonist
DRUG
Propranolol
DRUG
Quality-of-Life Assessment
OTHER
Questionnaire Administration
OTHER
Resistance Training
OTHER
Short-Term Fasting
OTHER
Lead Sponsor
Roswell Park Cancer Institute
NCT06356571
NCT05334069
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT04508790