Feasibility of Intermittent Fasting During Chemotherapy

Condition(s) studied

Investigational drug(s) / intervention(s)

Fasting: Fasting implies 0 kilojoule. Water ad libitum is permitted.

Study 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

Eligibility

Primary outcome measure(s)

• Safety, measured as 1) number of adverse events — 1 year
  To test whether fasting is safe. 1) Explored by investigating adverse events from intermittent water-only fasting
• Safety, measured as 2) changes in body weight — 1 year
  To test whether fasting is safe. 2) by investigating changes in body weight throughout the treatment comparing the intervention and control groups.
• Feasibility,- measured by 1) recruitment (attrition rate) — 1 year
  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.
• Feasibility,- measured as 2) compliance — 1 year
  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.
• Acceptability,- patient burden, acceptance and experience — 1 year
  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

Trial sites (1)

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