The goal of this randomized controlled parallel group trial is to examine if fasting before and after chemotherapy is safe, feasible and acceptable. The study population will include patients with either Hodgkin lymphoma or Diffuse Large B Cell Lymphoma. The main questions aimed to answer are: Whether fasting during chemotherapy is safe for patients, whether it is feasible to implement in a clinical setting, and whether patients find it acceptable. We also want to examine a number of patient-reported outcome measures regarding health status and quality of life, such as dietary intake and adverse events from chemotherapy. Researchers will compare fasting to standard treatment. Participants will: * Fast 24 hours before and 24 hours after chemotherapy in addition to standard treatment or receive only standard treatment * Keep a diary of their dietary intake 24 hours before and 24 hours after chemotherapy * Keep a diary of their dietary intake for three consecutive days between chemotherapy cycles * Answer questionnaires/questions in relation to side effects from fasting, side effects/adverse events of chemotherapy, quality of life * Take bioimpedance analysis (including body mass index and body composition) * Take blood- and feces samples
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
40
Fasting implies 0 kilojoule. Water ad libitum is permitted.
Department of Nutrition, University of Oslo
Oslo, Oslo, Norway
RECRUITINGSafety, measured as 1) number of adverse events
To test whether fasting is safe. 1) Explored by investigating adverse events from intermittent water-only fasting
Time frame: 1 year
Safety, measured as 2) changes in body weight
To test whether fasting is safe. 2) by investigating changes in body weight throughout the treatment comparing the intervention and control groups.
Time frame: 1 year
Feasibility,- measured by 1) recruitment (attrition rate)
Whether fasting is feasible. Explored in order to determine whether a larger trial can be successfully conducted in a similar setting with lymphoma patients fasting during cancer treatment.
Time frame: 1 year
Feasibility,- measured as 2) compliance
Whether fasting is feasible. Explored in order to determine whether a larger trial can be successfully conducted in a similar setting with lymphoma patients fasting during cancer treatment.
Time frame: 1 year
Acceptability,- patient burden, acceptance and experience
Whether fasting is acceptable. Explored from a perspective of the participant, as the degree to which patients find the trial, its procedures, and its interventions agreeable, suitable, and satisfactory during chemotherapy treatment
Time frame: 1 year
Adverse events from chemotherapy
Adverse events including number of infections, graded according to Common Terminology Criteria for Adverse Events
Time frame: 1 year
Toxicity, including hematological toxicity and standard organ toxicity
Evaluation of toxicity, including hematological toxicity and other relevant organ toxicities with blood test and using computer tomography (CT) or fluoro-deoxy-glucose positron emission tomography computer tomography (FDG-PET-CT)
Time frame: 1 year
Health-Related Quality of Life
By using EORTC QLQ-C30 questionnaire
Time frame: 1 year
Nutritional impact symptoms
The linguistic and content validation of the translated and culturally adapted Patient Generated Subjective Global Assessment (PG-SGA) will be utilized for gathering data on nutritional impact symptoms
Time frame: 1 year
Dietary intake
Dietary intake 24 hours before and 24 hours after chemotherapy and the usual intake between chemotherapy cycles using food diary.
Time frame: 1 year
Weight loss, body mass index (BMI) and body compositon
Bioelectrical impedance (BIA) will be used to collect data to explore changes in body weight, BMI and body composition.
Time frame: 1 year
Unplanned readmissions and hospitalization
In terms of numbers of readmissions, unplanned out- or inpatient visits, and days in the hospital
Time frame: 1 year
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