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

NCT07466862 | Not Yet Recruiting

• 1 other identifier: 0514-25-RMC
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Cancer; Sarcopenia; Muscle Mass Loss

Keywords

Quality of Life; Personalized Nutrition Therapy; Culinary Guidance; Food Preferences; Chemotherapy; Smell & Taste; Sensory Alterations; Sarcopenia; CopmpoCT

Outcome Measures

Primary Outcomes (4)

• 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.

  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).

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  From baseline throughout the month 6 study period - repeatedly evaluated across the study period between groups and within patient longitudinal changes.

Other Outcomes (1)

• 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).

  From baseline throughout the month 6 study period - repeatedly evaluated across the study period between groups and within patient longitudinal changes.

Study Arms (2)

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.

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.

Behavioral: Personalized Culinary and Nutrition Therapy

Interventions

Oncology Dietitian's Standard of Care BEHAVIORAL

Standard-of-care dietary management for cancer patients.

Oncology Dietitian Standard of Care

Personalized Culinary and Nutrition Therapy BEHAVIORAL

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.

Personalized Culinary and Nutrition Therapy

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Pregnancy or lactation are exclusion criteria.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gali Perel: lead

Study Sites (1)

Davidoff Center of Cancer, Rabin Medical Center

Petah Tikva, 49100, Israel

Location

MeSH Terms

Conditions

Neoplasms; Sarcopenia; Food Preferences; Anosmia

Interventions

Nutrition Therapy

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Feeding Behavior; Behavior; Olfaction Disorders; Sensation Disorders

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Daphna Murvitz, L.L.B.

CONTACT

+972-52-3883885; daphnamur@clalit.org.il

Sarit Anavi Cohen, PhD

CONTACT

+972-50-3214030; saritanavi@gmail.com, saritana@clalit.org.il,

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr. Gali Perl, MD, Director of Davidoff Day Care Unit, Rabin Medical Center

Study Record Dates

• First Submitted: February 22, 2026
• First Posted: March 12, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

IL (1)