A randomized clinical feasibility trial of time-restricted eating to improve response to therapy of multiple myeloma - FASTINA

KSH Campus Lübeck, Klinik für Hämatologie und Onkologie0 个研究点目标入组 54 人开始时间: 2024年6月21日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•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

•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

发起方

KSH Campus Lübeck, Klinik für Hämatologie und Onkologie