Personalized Cooking and Nutrition Guidance and Physical Activities Program to Reduce Muscle Loss in Advanced Cancer

March 29, 2026 updated by: Gali Perel

CuliCan Study A Multimodal Approach to Mitigate Muscle Mass Loss in Advanced Cancer Patients: Personalized Culinary Advice Addressing Mild to Moderate Muscle Mass Loss

People with advanced cancer often lose muscle over time. This can make them weaker, more tired, and reduce their quality of life. Many patients also struggle to eat because of changes in taste, smell, or appetite.

This study evaluates a new way to help slow muscle loss and support daily functioning.

The approach combines personalized food and cooking guidance with close nutrition demands support. The goal is to help patients eat better in a way that fits their personal needs.

It is hypothesized that this close, personalized treatment improves muscle loss and the quality of life of adults with advanced cancer who are receiving chemotherapy.

The study focuses on people with mild to moderate muscle mass loss currently undergoing or about to start chemotherapy and aims to slow further decline in their muscle mass.

The approach is designed to be practical and suitable for everyday life during cancer treatment.

About 200 adults with advanced cancer who are receiving, or about to receive, chemotherapy will take part in this study.

The study will take place at the Davidoff Cancer Center in Israel and will last 6 months.

Participants will be randomly assigned to one of two groups. One group will receive standard nutrition care from dietitians as well as ongoing physical activities programing and monitoring.

The other group will receive the same care, plus personalized cooking and food guidance tailored to their taste and smell changes. This group will also receive care based on careful measurements of their body's energy needs, body composition, and muscle strength.

These measurements will help the dietitian to offer more precise and personalized nutrition guidance over time.

Both groups will also receive advice about physical activity. Researchers will follow changes in muscle strength, physical function, nutrition status, and quality of life during the study.

The results will help determine whether personalized food and cooking support can better protect muscle mass and well-being in people with advanced cancer.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

After the completion of 20 patients in each group, an interim analysis will be performed to evaluate the safety and efficacy of the study. The following committee members will evaluate the results and determine whether the study should continue: Prof. Ilya Kagan, MD, Prof. Carla Prado, PhD, RD, FCAHS and Dr. Noa Gordon, PhD.

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Israel
      • Petah Tikva, Israel, 49100
        • Davidoff Center of Cancer, Rabin Medical Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Gali Perl, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Ambulatory males and females, age ≥ 18 years
  • Performance status (PS) 0-2
  • Patients with non-occlusive, metastatic malignancies of the gastrointestinal, lung, genitourinary, or breast origin (stage 4)
  • Receiving/about to receive chemotherapy treatment
  • Have an estimated life expectancy of at least 6 months
  • At least 4 weeks post major surgery
  • Mild to moderate muscle mass loss based on the SMI measure on compoCT
  • At risk of malnutrition according to the 'Malnutrition Universal Screening Tool' (MUST) (Score ≥2)
  • Able to understand and provide written informed consent
  • Willing and able to complete all study-specific procedures and visits
  • Willing and able (either personally or with the help of family members) to prepare meals according to the adjusted recipes

Exclusion Criteria:

  • Patients suffering from gastrointestinal obstruction
  • Patients with severe dietary restrictions
  • A medical condition that impacts the ability to increase muscle mass, as per the PI decision
  • Uncontrolled thyroid disease
  • Self-reported major dietary restrictions related to the intervention, such as irritable bowel syndrome (IBS)
  • Patients with a history or active eating disorder
  • Pregnant or lactating

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Oncology Dietitian Standard of Care
Patient will be treated according to the Davidoff oncology dietitian's standard of care. Patient will also receive a standard physical activity program and monitoring.
Behavioral: Oncology Dietitian's Standard of Care
Standard-of-care dietary management for cancer patients.
Experimental: Personalized Culinary and Nutrition Therapy

Patient will be treated according to the oncology dietitian's standard of care, including personalized culinary advice based on their individual taste and smell profile, along with close monitoring and management of their metabolism/physiologic needs (their resting energy expenditure, body composition, and hand strength). Dietitians will provide guidance using specially adapted recipes, professionally adjusted to meet individually profiled taste and smell needs, along with general science-based recommendations for meal preparation. Patient will also receive a standard physical activity program and monitoring.

Sensory alterations (taste and smell) and metabolic/physiological measures (resting energy expenditure, body composition, and hand strength) will be conducted every ±3-6 weeks. Each patient will participate in the study for ±6 months.
Behavioral: Personalized Culinary and Nutrition Therapy
Personalized culinary advice based on each patient's specific taste and smell profile, along with close monitoring and management of the patient's metabolism (resting energy expenditure, body composition, and hand strength) for ±6 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscle mass loss, assessed by SMI on CT examination, from baseline throughout the 6-month study period. CT scans obtained within a window of up to 2 months after completion of the participant's study participation may be used.
Time Frame: From baseline throughout the month 6 study period - repeatedly evaluated across the study period between groups and within patient longitudinal changes. CT scans obtained within a window of up to 2 months after completion of the participant's study parti
From baseline throughout the month 6 study period - repeatedly evaluated across the study period between groups and within patient longitudinal changes. CT scans obtained within a window of up to 2 months after completion of the participant's study parti
General quality of life, assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30), from baseline throughout the 6-month study period.
Time Frame: From baseline throughout the month 6 study period - repeatedly evaluated across the study period between groups and within patient longitudinal changes.
The raw score will be transformed to a standardized range from 0 to 100, according to the EORTC scoring manual. Higher scores indicate better functioning and QoL, whereas in the symptom subscale, higher scores indicate greater symptom burden (worse outcome).
From baseline throughout the month 6 study period - repeatedly evaluated across the study period between groups and within patient longitudinal changes.
General quality of life assessed by the Functional Assessment of Anorexia/Cachexia Treatment (FAACT), from baseline throughout the 6-month study period.
Time Frame: From baseline throughout the month 6 study period - repeatedly evaluated across the study period between groups and within patient longitudinal changes.
According to the FAACT scoring guidelines, the range of possible scores is 0-156, with 0 being the worst possible score and 156 the best.
From baseline throughout the month 6 study period - repeatedly evaluated across the study period between groups and within patient longitudinal changes.
Food-related quality of life, assessed by the QVA Questionnaire (from the French "Qualité de Vie Alimentaire"), from baseline throughout the 6-month study period.
Time Frame: From baseline throughout the month 6 study period - repeatedly evaluated across the study period between groups and within patient longitudinal changes.
The Global QVA score ranges from 35 to 140 points when the social (SOCIO) factor is included. A higher score on this scale indicates a better food-related quality of life.
From baseline throughout the month 6 study period - repeatedly evaluated across the study period between groups and within patient longitudinal changes.

Secondary Outcome Measures

Outcome Measure
Time Frame
Muscle function evaluated using handgrip (HG), from baseline throughout the 6-month study period.
Time Frame: From baseline throughout the month 6 study period - repeatedly evaluate across the study period between groups and within patient longitudinal changes.
From baseline throughout the month 6 study period - repeatedly evaluate across the study period between groups and within patient longitudinal changes.
Muscle function evaluated using the 6-minute walk (6MW) test, from baseline throughout the 6-month study period.
Time Frame: From baseline throughout the month 6 study period - repeatedly evaluated across the study period between groups and within patient longitudinal changes.
From baseline throughout the month 6 study period - repeatedly evaluated across the study period between groups and within patient longitudinal changes.
Muscle function evaluated using the sit-to-stand (STS) test, from baseline throughout the 6-month study period.
Time Frame: From baseline throughout the month 6 study period - repeatedly evaluated across the study period between groups and within patient longitudinal changes.
From baseline throughout the month 6 study period - repeatedly evaluated across the study period between groups and within patient longitudinal changes.
Muscle function evaluated using the time up and go (TUG) test, from baseline throughout the 6-month study period.
Time Frame: From baseline throughout the month 6 study period - repeatedly evaluated across the study period between groups and within patient longitudinal changes.
From baseline throughout the month 6 study period - repeatedly evaluated across the study period between groups and within patient longitudinal changes.
Hospitalization rate throughout the 6-month study period.
Time Frame: From baseline throughout the month 6 study period - repeatedly evaluated across the study period between groups and within patient longitudinal changes.
From baseline throughout the month 6 study period - repeatedly evaluated across the study period between groups and within patient longitudinal changes.

Other Outcome Measures

Outcome Measure
Time Frame
Daily energy provided through supplemental nutrition (oral nutritional supplements [ONS], enteral nutrition, or parenteral nutrition) across the 6-month study period, expressed as total kilocalories per day (kcal/day).
Time Frame: From baseline throughout the month 6 study period - repeatedly evaluated across the study period between groups and within patient longitudinal changes.
From baseline throughout the month 6 study period - repeatedly evaluated across the study period between groups and within patient longitudinal changes.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gali Perel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

June 1, 2028

Study Registration Dates

First Submitted

February 22, 2026

First Submitted That Met QC Criteria

March 8, 2026

First Posted (Actual)

March 12, 2026

Study Record Updates

Last Update Posted (Actual)

April 2, 2026

Last Update Submitted That Met QC Criteria

March 29, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0514-25-RMC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified IPD will be shared upon reasonably request, subjected to approval by the steering committee and IRB regulations, and a data use agreement

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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