CancerNCT07466862
Personalized Cooking and Nutrition Guidance and Physical Activities Program to Reduce Muscle Loss in Advanced Cancer
A study testing Personalized Culinary and Nutrition Therapy in people with Cancer and Sarcopenia, run by Gali Perel at 1 site in Israel.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Sarcopenia, Muscle Mass Loss
- What is being tested?
- Personalized Culinary and Nutrition Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2026to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site
Davidoff Center of Cancer, Rabin Medical Center
Petah Tikva, 49100
Daphna Murvitz, Adv, +972-52-3883885, daphnamur@clalit.org.il
Sarit Anavi Cohen, RD, PhD, +972-50-3214030, saritana@clalit.org.il
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Cancer, Sarcopenia, Muscle Mass Loss
- Being tested
- Oncology Dietitian's Standard of Care, Personalized Culinary and Nutrition Therapy
- Keywords
- Quality of Life, Personalized Nutrition Therapy, Culinary Guidance, Food Preferences, Chemotherapy, Smell & Taste, Sensory Alterations, Sarcopenia, CopmpoCT
- Medical subject headings
- Neoplasms, Sarcopenia, Food Preferences, Anosmia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oncology Dietitian's Standard of CareBehavioural
Standard-of-care dietary management for cancer patients.
Personalized Culinary and Nutrition TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Oncology Dietitian Standard of Care | Active comparator | 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. Receives: Behavioral: Oncology Dietitian's Standard of Care |
| Personalized Culinary and Nutrition Therapy | Experimental | 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. Receives: Behavioral: Personalized Culinary and Nutrition Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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).
Measured: 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.
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.
Measured: 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.
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.
Measured: From baseline throughout the month 6 study period - repeatedly evaluated across the study period between groups and within patient longitudinal changes.
Secondary outcomes (5)
Muscle function evaluated using handgrip (HG), from baseline throughout the 6-month study period.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From baseline throughout the month 6 study period - repeatedly evaluated across the study period between groups and within patient longitudinal changes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study startApr 2026 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gali Perel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gali Perel, Rabin Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07466862
- Sponsor's protocol ID
- 0514-25-RMC
- Status last verified
- Mar 2026
- First submitted
- 22 Feb 2026
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified IPD will be shared upon reasonably request, subjected to approval by the steering committee and IRB regulations, and a data use agreement
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CuliCan Study A Multimodal Approach to Mitigate Muscle Mass Loss in Advanced Cancer Patients: Personalized Culinary Advice Addressing Mild to Moderate Muscle Mass Loss
- ClinicalTrials.gov ID
- NCT07466862
- Acronym / sponsor ID
- 0514-25-RMC
- Conditions
- Cancer, Sarcopenia, Muscle Mass Loss
- Keywords
- Quality of Life, Personalized Nutrition Therapy, Culinary Guidance, Food Preferences, Chemotherapy, Smell & Taste, Sensory Alterations, Sarcopenia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Gali PerelUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 12 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oncology Dietitian Standard of Care | Active comparator | Behavioral: Oncology Dietitian's Standard of CarePatient will be treated according to the Davidoff oncology dietitian's standard of care. Patient will also receive a standard physical activity program and monitoring. |
| Personalized Culinary and Nutrition Therapy | Experimental | Behavioral: Personalized Culinary and Nutrition TherapyPatient 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oncology Dietitian's Standard of CareStandard-of-care dietary management for cancer patients. | Behavioural | Oncology Dietitian Standard of Care |
| Personalized Culinary and Nutrition TherapyPersonalized 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. | Behavioural | Personalized Culinary and Nutrition Therapy |
Primary outcome
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
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).
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.
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.
5 secondary outcomes
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.
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
- Individual participant dataSharing planned: Yes. De-identified IPD will be shared upon reasonably request, subjected to approval by the steering committee and IRB regulations, and a data use agreement
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized Culinary and Nutrition Therapy in people with Cancer and Sarcopenia, run by Gali Perel at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daphna Murvitz, L.L.B. (+972-52-3883885, daphnamur@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2026.