- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT05312255
Ei-kemoterapeuttiset interventiot elämänlaadun ja immuunitoiminnan parantamiseksi potilailla, joilla on multippeli myelooma
Monoklonaalista gammopatiaa sairastavien potilaiden isäntätekijöiden parantaminen
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.
Tutkimuksen yleiskatsaus
Tila
Ehdot
Yksityiskohtainen kuvaus
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 , D. (MDS patients will only be assigned in Module D) or E.
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.
MODULE E: Patients undergo resistance training sessions twice weekly supervised by a licensed and specialized personal trainer via the internet (e.g., remote access) for 9 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 9 months. Patients also undergo DEXA scans on study and collection of blood samples and bone marrow biopsy (as indicated for clinical care) throughout the trial
After completion of the study interventions, patients in module A and D are followed every 3 months for 1 year. Patients in module B are followed at 3 and 5 months. Patients in modules C and E are followed for 3 months.
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskelupaikat
-
-
New York
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Buffalo, New York, Yhdysvallat, 14263
- Rekrytointi
- Roswell Park Cancer Institute
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Ottaa yhteyttä:
- Jens Hillengass
- Puhelinnumero: 716-845-3863
- Sähköposti: jens.hillengass@roswellpark.org
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Päätutkija:
- Jens Hillengass
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
Inclusion Criteria:
-
Age >= 18 years of age
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Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of:
- Module A: ECOG 0 - 1
- Module B: ECOG 0 - 2
- Module C: ECOG 0 - 2
- Module D: ECOG 0-1
- Module E: ECOG 0-1
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MODULE A -C: Have a diagnosis of smoldering multiple myeloma, multiple myeloma or plasma cell leukemia (PCL) or
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MODULE D: non transfusion dependent low-risk MDS
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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
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Are able to understand and follow assessment and intervention procedures
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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
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MODULE A, D and E: (PHYSICAL ACTIVITY): Participant has access to a personal computer or tablet with camera, microphone, speakers and internet access
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MODULE B (NUTRITION): Not applicable
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MODULE C (BETA BLOCKER): Newly diagnosed patients with multiple myeloma necessitating treatment and before initiation of systemic therapy
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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 (PHYSICAL ACTIVITY): 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
- MODULE E (EX-MT): Have a planned autologous stem cell transplant (ASCT) for front line therapy
- MODULE E (EX-MT): Be enrolled in the Biorepository and Laboratory Services (BLS) Universal Consent with completed epidemiological questionnaire
- MODULE E (EX-MT): Report being inactive or low active during the peri-diagnosis and treatment period leading up to study enrollment
- MODULE E (EX-MT): Participant has access to a personal computer or tablet with camera, microphone, speakers and internet access
- MODULE E (EX-MT): Receive appropriate medical clearances to exercise
Exclusion Criteria:
- Major comorbidities that would cause danger to the patient when participating in the study and that would have a risk of progression if the patient took part in the study (including, but not limited to): cardiac or pulmonary and infectious diseases (e.g., ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia) or, psychiatric illness/social situations that would limit compliance with study requirements
- 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)
- MODULE A and E:(PHYSICAL ACTIVITY): Current and symptomatic pathological fracture(s) or severely advanced instability of the musculo-skeletal system that is deemed to making the patient unsafe to participate. This will be assessed by radiologist, a neurosurgeon and/or an orthopedic surgeon, if applicable.
- MODULE A and E: (PHYSICAL ACTIVITY): Current and symptomatic pathological fracture(s) or severely advanced instability of the musculo-skeletal system
- MODULE A and E: (PHYSICAL ACTIVITY): Acute bone instability as assessed by whole body low-dose computed tomography and evaluated by an experienced surgeon
- MODULE B (NUTRITION): Clinical signs of malnutrition (body mass index [BMI] < 18)
- MODULE B (NUTRITION): Special diets (physician prescribed)
- MODULE B (NUTRITION): Diabetic treated with glucose-lowering medications and/or insulin
- MODULE B (NUTRITION): Other reasons not to withhold food
- MODULE B (NUTRITION): Any condition which in the investigator's opinion deems the participant an unsuitable candidate to limit food consumption
- MODULE C (BETA BLOCKER): Current use of a beta blocker (includes all non-selective and beta-1 selective blockers) or, use of a beta-blocker within 3 months of study enrollment
- MODULE C (BETA BLOCKER): Contraindications to the use of beta-blockers, e.g.; severe sinus bradycardia; sick sinus syndrome; or heart block greater than first-degree, uncontrolled depression, unstable angina pectoris, uncontrolled heart failure (New York Heart Association [NYHA] Grade III or IV), hypotension ( systolic blood pressure < 100 mmHg), severe asthma or chronic obstructive pulmonary disease (COPD), uncontrolled type I or type II diabetes mellitus (HbA1C > 8.5 or 12h fasting plasma glucose > 160 mg/dL at screening), symptomatic peripheral arterial disease or Raynaud's syndrome, untreated pheochromocytoma, current calcium channel blocker use (Non-dihydropyridines such as verapamil) or rhythm control agents such as digoxin and amiodarone. Patients with pacemakers will be excluded
- MODULE C (BETA BLOCKER): Pregnant or nursing female participants, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test
- MODULE D: Cardiovascular disease which is deemed limiting exercise readiness by a cardiologist
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Ei satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Kokeellinen: 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. |
Ancillary studies
Muut nimet:
Ancillary studies Wear a FitBit device and receive prompts for 6 months
Muut nimet:
Undergo strength training for 6 months
Muut nimet:
|
|
Kokeellinen: 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. |
Ancillary studies
Muut nimet:
Ancillary studies Participate in intermittent fasting
Muut nimet:
|
|
Kokeellinen: Module C Group I (propranolol)
Patients receive propranolol PO BID for 3 months. |
Ancillary studies
Muut nimet:
Ancillary studies Given PO
Muut nimet:
|
|
Active Comparator: Module C Group II (propranolol)
Patients continue receiving beta-blocker regimen as per SOC for 3 months. |
Ancillary studies
Muut nimet:
Ancillary studies Receive beta-blocker regimen as per SOC
Muut nimet:
|
|
Kokeellinen: Module D
MDS Patients undergo strength training for 6 months. |
Wear a FitBit device and receive prompts for 6 months
Muut nimet:
Undergo strength training for 6 months
Muut nimet:
|
|
Kokeellinen: Module E
Patients undergo resistance training sessions twice weekly supervised by a licensed and specialized personal trainer via the internet (e.g., remote access) for 9 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 9 months. Patients also undergo DEXA scans on study and collection of blood samples and bone marrow biopsy (as indicated for clinical care) throughout the trial. |
Wear a FitBit device and receive prompts for 6 months
Muut nimet:
Undergo strength training for 6 months
Muut nimet:
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Changes in immune cell subsets
Aikaikkuna: At baseline and at 1 year
|
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
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Changes in the gut microbiome
Aikaikkuna: At 1 and 3 months
|
Fecal samples will be collected and compared from group with physical exercise,compared to group doing intermittent fasting). |
At 1 and 3 months
|
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Comparison in bone markers
Aikaikkuna: At 1 and 3 months
|
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
Aikaikkuna: 3 months
|
Dexa (bone density scan) will be performed at 1 and 3 months |
3 months
|
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Changes in stress
Aikaikkuna: At 1 and 3 months
|
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
Aikaikkuna: At 1 and 3 months
|
As assessed by the Generalized Anxiety Disorder 7-item Scale |
At 1 and 3 months
|
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Changes in fatigue as assessed by EORTC-LQLQ-FA12
Aikaikkuna: At 1 and 3 months
|
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
Aikaikkuna: At 1 and 3 months
|
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
Aikaikkuna: Up to 5 months
|
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
Aikaikkuna: Up to 6 months
|
Will be evaluated using a linear mixed model and will be used to compare mean levels between timepoints. |
Up to 6 months
|
Yhteistyökumppanit ja tutkijat
Sponsori
Tutkijat
- Päätutkija: Jens Hillengass, Roswell Park Cancer Institute
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
- Verisuonisairaudet
- Sydän-ja verisuonitaudit
- Neoplasmat
- Immuunijärjestelmän sairaudet
- Neoplasmat histologisen tyypin mukaan
- Hematologiset sairaudet
- Lymfoproliferatiiviset häiriöt
- Immunoproliferatiiviset häiriöt
- Precancerous tilat
- Neoplasmat, plasmasolut
- Hemostaattiset häiriöt
- Paraproteinemiat
- Veren proteiinien häiriöt
- Hemorragiset häiriöt
- Hypergammaglobulinemia
- Hemic- ja imusuutteet
- Kytevä multippeli myelooma
- Multippeli myelooma
- Huumeiden fysiologiset vaikutukset
- Farmakologisen vaikutuksen molekyylimekanismit
- Neurotransmitterit
- Adrenergiset aineet
- Adrenergiset antagonistit
- Moottoritoiminta
- Liike
- Tuki- ja liikuntaelinten fysiologiset ilmiöt
- Tuki- ja hermosto- ja hermostofysiologiset ilmiöt
- Orgaaniset kemikaalit
- Terapeuttiset lääkkeet
- Farmakologiset vaikutukset
- Kemialliset vaikutukset ja käyttötarkoitukset
- Hiilivety
- Hiilivedyt, sykliset
- Fysioterapiatapa
- Naftaleenit
- Poltisykliset aromaattiset hiilivedyt
- Hiilivedyt, aromaattiset
- Polisykliset yhdisteet
- Amiini
- Potilashoito
- Psykoterapia
- Käyttäytymistieteet ja toiminnot
- Liikuntahoito
- Kuntoutus
- Jälkihoito
- Potilaan hoidon jatkuvuus
- Alkoholit
- Fenoksipropanoliamiinit
- Propanoliamiini
- Amino -alkoholit
- Propanolit
- Fyysinen ilmastointi, ihminen
- Käyttää
- Adrenergiset beeta-antagonistit
- Propranololi
- Vastusharjoittelu
- Käyttäytymisterapia
Muut tutkimustunnusnumerot
- I 1680221
- I 1680221 (Muu tunniste: Roswell Park Cancer Institute)
- NCI-2022-01918 (Rekisterin tunniste: CTRP (Clinical Trial Reporting Program))
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