DRKS00034370
Not yet recruiting
Phase 2
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 sites54 target enrollmentJune 21, 2024
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- C90.0
- Sponsor
- KSH Campus Lübeck, Klinik für Hämatologie und Onkologie
- Enrollment
- 54
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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.
Outcomes
Primary Outcomes
Not specified
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