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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2022-01918 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| I 1680221 | Other Identifier | Roswell Park Cancer Institute |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Module A (strength training, behavioral intervention) | Experimental | 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. |
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| Module B (intermittent fasting) | Experimental | 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. |
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| Module C Group I (propranolol) | Experimental | Patients receive propranolol PO BID for 3 months. |
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| Module C Group II (propranolol) | Active Comparator | Patients continue receiving beta-blocker regimen as per SOC for 3 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral Intervention | Behavioral | Wear a FitBit device and receive prompts for 6 months |
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| Measure | Description | Time Frame |
|---|---|---|
| Changes in immune cell subsets | Will be assessed by flow cytometry, comparing levels before and after one of three lifestyle interventions (physical exercise, intermittent fasting, beta blocker therapy). Will use a linear mixed model. Since the form of the model is unknown a priori, the power calculations are based on comparing any two timepoints using a two-sided paired t-test. With n=100, we have 80% power (at alpha = 0.05/3) to detect a difference of at least 0.33 standard deviations (SD). | At baseline and at 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the gut microbiome | Fecal samples will be collected and compared from group with physical exercise,compared to group doing intermittent fasting). | At 1 and 3 months |
| Comparison in bone markers |
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Inclusion Criteria:
Age >= 18 years of age
Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of:
MODULE A, B and C: Have a diagnosis of smoldering multiple myeloma, multiple myeloma or plasma cell leukemia (PCL) or
MODULE D: non transfusion dependent low-risk MDS
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 intervention procedures
Participant 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
MODULE A and D (PHYSICAL ACTIVITY): Participant has access to a personal computer or tablet with camera, microphone, speakers and internet access
MODULE B (NUTRITION): Not applicable
MODULE C (BETA BLOCKER): Newly diagnosed patients with multiple myeloma necessitating treatment and before initiation of systemic therapy
MODULE C: Female participants of child-bearing potential must have a negative pregnancy test at study entry and then agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. Male patients with female partners of child-bearing potential should also use adequate contraceptive methods (see above). Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately MODULE D: Patients with MDS not necessitating transfusion therapy at time of enrollment (no transfusion within 8 weeks prior to enrollment) i.e. patients on observation, or receiving growth factors or luspatercept only
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jens Hillengass | Roswell Park Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Roswell Park Cancer Institute | Recruiting | Buffalo | New York | 14263 | United States |
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| Module D | Experimental | MDS Patients undergo strength training for 6 months. |
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| Beta-Adrenergic Antagonist | Drug | Receive beta-blocker regimen as per SOC |
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| Propranolol | Drug | Given PO |
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| Quality-of-Life Assessment | Other | Ancillary studies |
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| Questionnaire Administration | Other | Ancillary studies |
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| Resistance Training | Other | Undergo strength training for 6 months |
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| Short-Term Fasting | Other | Participate in intermittent fasting |
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Will be assessed from intermittent fasting serum samples compared to serum samples of those doing physical exercise.
| At 1 and 3 months |
| Changes in body composition | Dexa (bone density scan) will be performed at 1 and 3 months | 3 months |
| Changes in stress | Significant differences among groups in the mean Perceived Stress Scale (PSS) score, which measures the stress severity perceived by the subjects in the last month. The scale is constituted by 10 items that are self-rated by the subject on a 0-4 Likert scale. The scale minimum total score is 0, the maximum is 40. Higher total scores indicate a worse outcome | At 1 and 3 months |
| Changes in anxiety | As assessed by the Generalized Anxiety Disorder 7-item Scale | At 1 and 3 months |
| Changes in fatigue as assessed by EORTC-LQLQ-FA12 | 12-item multidimensional fatigue questionnaire.The scale scores from 1 to 4: 1 ("Not at all"), 2 ("A little"), 3 ("Quite a bit") and 4 ("Very much"). The range is 3. For the raw score, less points are considered to have a better outcome. | At 1 and 3 months |
| Change in functional status | basic assessment of physical activity before diagnosis will be compared to one administered at follow up | At 1 and 3 months |
| Changes in nutritional behavior before and after intermittent fasting | Will be modeled using a GEE logistic model. Rates of positive nutritional behavior will be compared beween time points. | Up to 5 months |
| Changes in stress-related biomarkers | Will be evaluated using a linear mixed model and will be used to compare mean levels between timepoints. | Up to 6 months |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D000075122 | Smoldering Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D011230 | Precancerous Conditions |
| D006942 | Hypergammaglobulinemia |
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| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D000319 | Adrenergic beta-Antagonists |
| D011433 | Propranolol |
| D055070 | Resistance Training |
| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D018674 | Adrenergic Antagonists |
| D018663 | Adrenergic Agents |
| D018377 | Neurotransmitter Agents |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D045505 | Physiological Effects of Drugs |
| D050198 | Phenoxypropanolamines |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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