Clinical trial · Interventional
A Case Crossover Study of Intermittent Fasting in CLL/SLL
Does Timing Matter? A Case Crossover Study of Intermittent Fasting in Patients With CLL/SLL at BC Cancer- Victoria
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to compare the 16/8 intermittent fasting method with the 5:2 Method in a subset of patients with chronic lymphocytic leukemia or small lymphocytic lymphoma at BC Cancer- Victoria. The purpose is to find out which is the preferred method by patients and which has the greatest effect on: * cancer cells (lymphyocyte count), * metabolism (autophagy activation), * inflammation (CRP), * gut microbiome (metabolomic analysis). Participants will have already completed our previous trial, "Intermittent Fasting in CLL/SLL" (ClinicalTrials.gov Identifier: NCT04626843) where they followed the 16/8 Fasting Method followed by a minimum of a 3 months washout period, and will now follow the 5:2 Method for 90 days. The same samples and outcome measures will be collected in order to directly compare the two diets in the same patient cohort.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Lymphocytic Leukemia (CLL) | Chronic Lymphocytic Leukemia | ALIAS | 0.90 |
| Small Lymphocytic Lymphoma (SLL) | Small Lymphocytic Lymphoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 16/8 Method (intermittent fast regimen) | Behavioral | — | UNRESOLVED |
| 5:2 Method (intermittent fasting regimen) | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 5:2 Method
- description
- Participants will follow the 5:2 Method (an intermittent fasting regimen) for a 90 day duration. This entails eating ad libitum for five days per week ("normal days") and limiting total calorie intake to 800kcals per day ("fasting days") for the remaining two days per week. The fasting days can be sequential or dispersed throughout the week, based on patient preference.
- interventionNames
- Behavioral: 5:2 Method (intermittent fasting regimen)
- type
- ACTIVE_COMPARATOR
- label
- 16/8 Method
- description
- Participants will have already followed the 16/8 Method (an intermittent fasting regimen) for a minimum of six days per week for a 90 day duration. This entailed limiting the eating hours to an 8-hour window, then fasting for the remaining 16 hours per day, with the last time of intake being 8pm.
- interventionNames
- Behavioral: 16/8 Method (intermittent fast regimen)
Primary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of CLL or SLL * Age \< 85 years * Peripheral blood lymphocytes \>20 x 109/L * Hemoglobin \> 90g/L * Platelets \> 90 x 10\*9/L * BMI of \>=20kg/m2 * ECOG Performance Status \>=2 * Completion of "IF in CLL/SLL Study" (ClinicalTrials.gov Identifier: NCT04626843) followed by minimum of 3 month ad libitum eating Exclusion Criteria: * Patient unable to give consent * Patient on medications required to be taken with food during the fasting window * Pregnancy * Diabetes mellitus * BMI drop to \< 18.5kg/m2 at any time during study * Anti-lymphoma therapy within the past 3 months * Expected to require initiation of anti-lymphoma therapy within the next 3 months
References
Publications (1)
- BACKGROUNDStringer E, Lum JJ, Macpherson N. Intermittent Fasting in Cancer: a Role in Survivorship? Curr Nutr Rep. 2022 Sep;11(3):500-507. doi: 10.1007/s13668-022-00425-0. Epub 2022 May 31. PMID 35639262