Feasibility of Intermittent Fasting During Chemotherapy

NCT06645093 | Enrolling By Invitation

• 1 other identifier: FasteStudien
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

Chemotherapeutic Toxicity; Chemotherapy; Adverse Effect; Short-term fasting; Feasibility studies; Fasting

Outcome Measures

Primary Outcomes (5)

• Safety, measured as 1) number of adverse events

  To test whether fasting is safe. 1) Explored by investigating adverse events from intermittent water-only fasting

  1 year

• Safety, measured as 2) changes in body weight

  To test whether fasting is safe. 2) by investigating changes in body weight throughout the treatment comparing the intervention and control groups.

  1 year

• Feasibility,- measured by 1) recruitment (attrition rate)

  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.

  1 year

• Feasibility,- measured as 2) compliance

  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.

  1 year

• Acceptability,- patient burden, acceptance and experience

  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

  1 year

Secondary Outcomes (7)

• Adverse events from chemotherapy

  1 year

• Toxicity, including hematological toxicity and standard organ toxicity

  1 year

• Health-Related Quality of Life

  1 year

• Nutritional impact symptoms

  1 year

• Dietary intake

  1 year

Other Outcomes (2)

• Mechanistic aspects of fasting

  1 year

• Fasting and microbiota

  1 year

Study Arms (2)

Fasting group

EXPERIMENTAL

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

Other: Fasting

Control group

NO INTERVENTION

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

Interventions

Fasting OTHER

Fasting implies 0 kilojoule. Water ad libitum is permitted.

Fasting group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oslo: lead
• Oslo University Hospital: collaborator
• St. Olavs Hospital: collaborator
• Akershus University Hospital Trust: collaborator

Study Sites (1)

Department of Nutrition, University of Oslo

Oslo, Oslo County, 0372, Norway

Location

MeSH Terms

Conditions

Lymphoma; Neoplasms; Fasting; Intermittent Fasting

Interventions

Angptl4 protein, mouse

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Feeding Behavior; Behavior

Study Officials

• Sonja Brunvoll, PhD

  Department of Nutrition, University of Oslo

  PRINCIPAL INVESTIGATOR

• Inger Ottestad, PhD

  Department of Nutrition, University of Oslo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoctoral researcher Sonja H. Brunvoll, PhD (co-PI together with Inger Ottestad, PhD)

Model Details: Safety and feasibility study,-pilot study

Study Record Dates

• First Submitted: October 14, 2024
• First Posted: October 16, 2024
• Study Start: October 31, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)