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Trial Title:
Feasibility of Intermittent Fasting During Chemotherapy
NCT ID:
NCT06645093
Condition:
Lymphoma
Cancer
Fasting
Conditions: Official terms:
Lymphoma
Conditions: Keywords:
Chemotherapeutic Toxicity
Chemotherapy
Adverse Effect
Short-term fasting
Feasibility studies
Fasting
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Safety and feasibility study,-pilot study
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Fasting
Description:
Fasting implies 0 kilojoule. Water ad libitum is permitted.
Arm group label:
Fasting group
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
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Start date:
October 2024
Completion date:
July 2025
Lead sponsor:
Agency:
University of Oslo
Agency class:
Other
Collaborator:
Agency:
Oslo University Hospital
Agency class:
Other
Source:
University of Oslo
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06645093
