Ignite Creation Date:
2025-12-25 @ 1:17 AM
Ignite Modification Date:
2025-12-27 @ 3:03 AM
Study NCT ID:
NCT06645093
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-08-12
First Post:
2024-10-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility of Intermittent Fasting During Chemotherapy
Sponsor:
University of Oslo
Organization:
Study Overview
Official Title:
Intermittent Fasting During Curatively Intended Chemotherapy for Malignant Lymphoma - a Randomized Feasibility Trial
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Fastestudien
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: