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| Name | Class |
|---|---|
| Oslo University Hospital | OTHER |
| St. Olavs Hospital | OTHER |
| Akershus University Hospital Trust | UNKNOWN |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fasting group | Experimental | This group will fast 24 hours before and 24 hours after chemotherapy for all treatment cycles (4-6 cycles). |
|
| Control group | No Intervention | This group will receive standard treatment, which include no fasting. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fasting | Other | Fasting implies 0 kilojoule. Water ad libitum is permitted. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | 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. | 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. | 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 | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events from chemotherapy | Adverse events including number of infections, graded according to Common Terminology Criteria for Adverse Events | 1 year |
| Toxicity, including hematological toxicity and standard organ toxicity |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 1 year |
| Fasting and microbiota |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sonja Brunvoll, PhD | Department of Nutrition, University of Oslo | Principal Investigator |
| Inger Ottestad, PhD | Department of Nutrition, University of Oslo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Nutrition, University of Oslo | Oslo | Oslo | 0372 | Norway |
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| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009369 | Neoplasms |
| D005215 | Fasting |
| D000093763 | Intermittent Fasting |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C407088 | Angptl4 protein, mouse |
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Safety and feasibility study,-pilot study
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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)
| 1 year |
| Health-Related Quality of Life | By using EORTC QLQ-C30 questionnaire | 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 | 1 year |
| Dietary intake | Dietary intake 24 hours before and 24 hours after chemotherapy and the usual intake between chemotherapy cycles using food diary. | 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. | 1 year |
| Unplanned readmissions and hospitalization | In terms of numbers of readmissions, unplanned out- or inpatient visits, and days in the hospital | 1 year |
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. |
| 1 year |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D005247 | Feeding Behavior |
| D001519 | Behavior |