C90.0
Conditions
Interventions
Group 1: Daily time-restricted eating (16:8) during 12 weeks in addition to nutritional counseling as per standard of local site
Group 2: 12 weeks during standard-of-Care system therapy + nutritional
Sponsors
UKSH Campus Lübeck, Klinik für Hämatologie und Onkologie
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Newly diagnosed or relapsed/ refractory according to IMWG criteria 2. Willingness to receive system therapy (after detailed explanation) 3. Ability to understand and willingness to sign written informed consent. 4. Willingness and ability to comply with the scheduled visits, treatment plan, laboratory tests and other study procedures 5. Signed informed consent must be obtained before any study specific procedure 6. Ability to complete questionnaires individually 7. Willingness and ability to follow time-restricted eating when randomized in experimental Arm A 8. WHO performance status 0-2 (WHO=3 is allowed only if caused by multiple myeloma and not by co-morbid conditions) 9. For Women of Childbearing potential and Males with female partners of childbearing potential: Willingness to use adequate contraception
Exclusion criteria
Exclusion criteria: 1. Inability to undergo caloric restriction, BMI < 20 kg/m² or cachexia (defined as unintentional weight loss in the last 6 months of more than 5% or unintentional weight loss in the last 12 months of more than 10%) 2. Recent autologous stem cell transplantation (less than 100 days ago) 3. History of eating disorder 4. Ongoing nutritional support in the form of high-calorie drinks or parenteral nutrition 5. Active infection requiring intravenous broad spectrum antibiotica, antifungal medication or antiviral treatment at time point of inclusion. 6. Uncontrolled Diabetes mellitus requiring treatment. 7. Any condition requiring continuous food supplement. 8. Severe grade 3 thyroid dysfunction 9. Known to be HIV+ or to have hepatitis A, B, or C active infection 10. Uncontrolled or active HBV infection: Patients with positive HBsAg and/or HBV DNA. 11. Advanced liver (Child B cirrhosis) or renal insufficiency (GFR < 30 ml/min) 12. Pregnancy and lactation 13. Prisoners or subjects who are legally institutionalized, or those unwilling or unable to comply with scheduled visits, drug administration plan, laboratory tests, other study procedures, and study restrictions 14. Any clinically significant, uncontrolled medical conditions that, in the Investigator's opinion, would expose the patient to excessive risk or may interfere with compliance or interpretation of the study results 15. Failure to fulfil inclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adherence to time-restricted eating scheme in the experimental arm until T1 Complete remission (CR) and/or MRD (10-5) negativity (according to IMWG criteria) at T1 (End of Treatment) | — |
Secondary
| Measure | Time frame |
|---|---|
| - SD (Stable disease), PR (partial remission); VGPR (Very good partial remission), CR (Complete remission), sCR sowie MRD (Minimal residual disease) negativity at T1 (End of Treatment) - Nutritional status (body weight, BMI (Body Mass index), Waist-Hip-Ratio, waist circumference, phase-angle in bioelectrical impedance analysis (BIA)) at screening and every 4 weeks after randomization until end of treatment - Adverse events grade III (according to CTCAE(Common Terminology Criteria for Adverse Events) v.5.0) until T1 - Alteration of global QoL (Quality of life score (EORTC QLQ-30) between screening (T0) and T1 - Fatigue (FACIT®/FACT-G) at screening (T0) and T1. | — |
Countries
Germany
Contacts
Public ContactAnna Franziska Hamm
UKSH Campus Lübeck, Klinik für Hämatologie und Onkologie
Outcome results
None listed