NCT05708326Completed
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 · Last updated 8 Mar 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 6 (actual)
- First submitted
- 21 Dec 2022
- Start date
- 12 Jun 2023
- Primary completion date
- 30 Oct 2023
- Lead sponsor
- British Columbia Cancer Agency
- Diseases
- Chronic lymphocytic leukaemia
- NCT number
- NCT05708326
What you commit to
- Study type: Interventional
- Participants enrolled: 6
- From 12 Jun 2023 to the primary completion date, 30 Oct 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patient on medications required to be taken with food during the fasting window
- Anti-lymphoma therapy within the past 3 months
- Expected to require initiation of anti-lymphoma therapy within the next 3 months
Other illness
- Diabetes mellitus
Other
- Patient unable to give consent
- Pregnancy
- BMI drop to \< 18.5kg/m2 at any time during study
Who the study is looking for
- 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
Age in the registry: 19 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Eleah Stringer Coordinator of this site? Confirm its status | Victoria | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.