About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients diagnosed with diffuse large B-cell lymphoma planned to receive R-CHOP (rituximab, vincristine, doxorubicin, cyclophosphamide, and prednisolone) and Hodgkin lymphoma receiving ABVD (doxorubicin, bleomycin, vinblastine and dacarbazine)
Age ≥ 18 years
ECOG status 0-2
Normal weight and overweight (BMI ≥ 18,5 kg/m²)
Disqualifiers
Receiving concurrent radiation therapy and/or treatment
Other concomitant disease that may make intermittent fasting complicated such as diabetes mellitus
ECOG status: > 3
BMI < 18,5 kg/m2
Trial design
Parallel
Treatments tested in this trial
Fasting
Other interventionFasting implies 0 kilojoule. Water ad libitum is permitted.
Treatment groups
Trial outcomes
Primary outcomes
Safety, measured as 1) number of adverse events
To test whether fasting is safe. 1) Explored by investigating adverse events from intermittent water-only fasting
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.
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.
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.
Secondary outcomes
Adverse events from chemotherapy
Adverse events including number of infections, graded according to Common Terminology Criteria for Adverse Events
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)
Health-Related Quality of Life
By using EORTC QLQ-C30 questionnaire
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
Other outcomes
Mechanistic aspects of fasting
To better understand nutrition and metabolism related to fasting and cancer, we want to examine various biomarkers related to glucose, amino acid and fat metabolism, and inflammation, such as e.g. glucose, insulin, amino acids, triglycerides, C-reactive protein (CRP).
Fasting and microbiota
We will analyze the gut microbiota to explore the effect of fasting on the gut microbiota. We will collect feces samples at start and end of treatment to characterize the microbiota using high throughput sequencing.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Oslo
Lead sponsor
Oslo University Hospital
Collaborator
St. Olavs Hospital
Collaborator
Akershus University Hospital Trust
Collaborator