Cancer, Fasting, Lymphoma
Conditions
Keywords
Chemotherapeutic Toxicity, Chemotherapy, Adverse Effect, Short-term fasting, Feasibility studies, Fasting
Brief summary
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
OTHERFasting
Fasting implies 0 kilojoule. Water ad libitum is permitted.
Sponsors
Akershus University Hospital Trust
University of Oslo
Oslo University Hospital
St. Olavs Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Safety and feasibility study,-pilot study
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety, measured as 1) number of adverse events | 1 year | 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 | 1 year | 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) | 1 year | 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 | 1 year | 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. |
| Acceptability,- patient burden, acceptance and experience | 1 year | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events from chemotherapy | 1 year | Adverse events including number of infections, graded according to Common Terminology Criteria for Adverse Events |
| Toxicity, including hematological toxicity and standard organ toxicity | 1 year | 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 | 1 year | By using EORTC QLQ-C30 questionnaire |
| Nutritional impact symptoms | 1 year | 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 |
| Dietary intake | 1 year | Dietary intake 24 hours before and 24 hours after chemotherapy and the usual intake between chemotherapy cycles using food diary. |
| Weight loss, body mass index (BMI) and body compositon | 1 year | Bioelectrical impedance (BIA) will be used to collect data to explore changes in body weight, BMI and body composition. |
| Unplanned readmissions and hospitalization | 1 year | In terms of numbers of readmissions, unplanned out- or inpatient visits, and days in the hospital |
Countries
Norway
Contacts
CONTACTSonja Brunvoll, PhD
CONTACTInger Ottestad, PhD
PRINCIPAL_INVESTIGATORSonja Brunvoll, PhD
Department of Nutrition, University of Oslo
PRINCIPAL_INVESTIGATORInger Ottestad, PhD
Department of Nutrition, University of Oslo
Outcome results
None listed