Feasibility of Intermittent Fasting During Chemotherapy

NCT ID: NCT06645093

Last Updated: 2025-08-12

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-31
• Study Completion Date: 2026-12-31

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

Conditions

Lymphoma; Cancer; Fasting

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Fasting group

This group will fast 24 hours before and 24 hours after chemotherapy for all treatment cycles (4-6 cycles).

Group Type: EXPERIMENTAL

Fasting

Intervention Type: OTHER

Fasting implies 0 kilojoule. Water ad libitum is permitted.

Control group

This group will receive standard treatment, which include no fasting.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Fasting

Fasting implies 0 kilojoule. Water ad libitum is permitted.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oslo University Hospital

OTHER

Sponsor Role: collaborator

University of Oslo

OTHER

Sponsor Role: lead

Responsible Party

Sonja H. Brunvoll, PhD

Postdoctoral researcher Sonja H. Brunvoll, PhD (co-PI together with Inger Ottestad, PhD)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sonja Brunvoll, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Nutrition, University of Oslo

Inger Ottestad, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Nutrition, University of Oslo

Locations

Department of Nutrition, University of Oslo

Oslo, Oslo County, Norway

Countries

Norway

Other Identifiers

FasteStudien

Identifier Type: -

Identifier Source: org_study_id