Feasibility of Intermittent Fasting During Chemotherapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Fasting.
- Who it may be relevant to
- Registry conditions: Lymphoma, Cancer, Fasting. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Norway
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Intermittent Fasting During Curatively Intended Chemotherapy for Malignant Lymphoma - a Randomized Feasibility Trial
Overview
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
Interventions
- Other Fasting
Fasting implies 0 kilojoule. Water ad libitum is permitted.
Primary outcome measures
- Safety, measured as 1) number of adverse events [Time frame: 1 year]
- Safety, measured as 2) changes in body weight [Time frame: 1 year]
- Feasibility,- measured by 1) recruitment (attrition rate) [Time frame: 1 year]
- Feasibility,- measured as 2) compliance [Time frame: 1 year]
- Acceptability,- patient burden, acceptance and experience [Time frame: 1 year]
Secondary outcome measures (7)
- Adverse events from chemotherapy [Time frame: 1 year]
- Toxicity, including hematological toxicity and standard organ toxicity [Time frame: 1 year]
- Health-Related Quality of Life [Time frame: 1 year]
- Nutritional impact symptoms [Time frame: 1 year]
- Dietary intake [Time frame: 1 year]
- Weight loss, body mass index (BMI) and body compositon [Time frame: 1 year]
- Unplanned readmissions and hospitalization [Time frame: 1 year]
Eligibility criteria
Inclusion criteria
- 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/m\^2)
Exclusion criteria
- 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
- Age > 80 years
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Norway · 1 center
- Department of Nutrition, University of Oslo — Oslo
Identifiers
NCT: NCT06645093 · FasteStudien