Rectal CancerKOMPARCNCT05938322
Ketogenic Diet Compliance in Patients Undergoing Radiotherapy for Pelvic Cancers
A study testing Ketogenic Diet and Standard Diet in people with Rectal Cancer, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
Patients with locally advanced non-metastatic adenocarcinoma of the rectum undergoing chemoradiation therapy will be assigned to 2 groups: the intervention group will be prescribed an individualized ketogenic eating plan to be followed throughout the treatment period the control group will be prescribed a diet therapy… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Ketogenic Diet and Standard Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- 1 siteItaly
- Study dates
- 10 Jun 2024to Dec 2027
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologic confirmation of rectal adenocarcinoma
- Locally advanced rectal cancer
- Patients undergoing neoadjuvant radiotherapy treatment
- Signature of informed consent to the processing of personal data
Who cannot join
- Severely malnourished patients according to GLIM (Global Leadership Initiative on Malnutrition) criteria
- Patients treated for palliative purposes
- Patients with metastatic disease
- Diabetes mellitus
- Pregnancy or lactation
- Significant food allergies that would make the person unable to consume the food provided
- Refusal to participate in the proposed clinical trial
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Universitario Agostino Gemelli, IRCCS
Rome
About this study
Official title: Compliance With Ketogenic Diet in Patients Undergoing Radiotherapy for Pelvic Cancers: a Prospective, Randomized, Mono-centric Study
Patients with locally advanced non-metastatic adenocarcinoma of the rectum undergoing chemoradiation therapy will be assigned to 2 groups:
- the intervention group will be prescribed an individualized ketogenic eating plan to be followed throughout the treatment period
- the control group will be prescribed a diet therapy plan treatment following the international guidelines of clinical nutrition, also to be followed during treatment
Read the detailed description
Some days before the start of radiotherapy there will be the first visit in which patients will be enrolled and placed in one of the following two groups:
- The intervention group (KD) will be prescribed a ketogenic diet therapy plan characterized by the following composition: carbohydrates < 30g/day, 1.2g-1.5g protein/kg/day and lipids > 65%.
- The control group (SD) will be prescribed a nutrition plan based on the Mediterranean diet model according to ESPEN guidelines (carbohydrates 45-55%, protein 15-20% and lipids 30-35%) There will then be two additional follow-ups for patients: one during the period of therapy and one at the end of therapy.
Compliance with diet therapy treatment (SD vs. KD) will be assessed by analysis of a food diary that the patient will be asked to complete.
During follow-ups it will be assessed:
- BMI and body composition (by bioimpedance analysis)
- Muscle strength and physical performance (by hand grip test and sit-to-stand test) Compliance with and toxicity of radiochemotherapy treatment will be assessed at the radiochemotherapy visits (3 visits during treatment)
- Conditions
- Rectal Cancer
- Being tested
- Ketogenic Diet, Standard Diet
- Keywords
- Rectal Cancer, Ketogenic Diet
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketogenic DietOther
In the group of intervention is prescribed a ketogenic diet plan characterized by the following composition: carbohydrates < 30g/day, 1.2g-1.5g protein/kg/day and lipids > 65%.
This diet will be followed during the period of treatment with chemo-radiotherapy (5 weeks)
Standard DietOther
The control group (SD) will follow the Mediterranean diet pattern based on ESPEN guidelines (carbohydrates 45-55%, protein 15-20% and lipids 30-35%).
| Study group | Role | What they receive |
|---|---|---|
| Ketogenic Diet | Experimental | In the group of intervention is prescribed a ketogenic diet plan. Receives: Other: Ketogenic Diet |
| Standard Diet | Active comparator | The control group (SD) will follow the Mediterranean diet pattern based on ESPEN (European Society of Parenteral and Enteral Nutrition) guidelines Receives: Other: Standard Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to the ketogenic diet
The primary objective is to assess the adherence to the diet therapy treatment plan (SD vs. KD). It will be verified through a food diary that will be given to the patient during the first visit.
The patients will fill out the questionnaire and return it at future visits.
Measured: 2 months
Secondary outcomes (7)
Assessment of fat mass (FM) in the group of patients on ketogenic diet (KD) compared with the control group
The assessment will be carried out through the use of an impedance analysis (BIA)
Measured: 2 months
Evaluation of maintenance of metabolically active mass (BCM) in the group of patients on ketogenic diet (KD) compared with the control group
The assessment will be carried out through the use of an impedance analysis (BIA)
Measured: 2 months
Investigate the impact of BCM maintenance on metabolic, inflammatory, hematologic and endocrine response
The assessment will be carried out through blood test analysis
Measured: 2 months
Evaluation of the correlation between ketogenic diet (KD) and metabolic, inflammatory, hematologic and endocrine response
The assessment will be carried out through blood test analysis
Measured: 2 months
Evaluation of the tolerability to the treatment
Radiotherapy interruptions will be evaluated
Measured: 2 months
Evaluation of the response to the treatment
The assessment will be carried out through pelvic MRI analysis, clinical evaluation, and pathological response
Measured: 2 months
Investigate indices of quality of life
Investigating patients' quality of life through questionnaires administered at the beginning and at the end of treatments. The questionnaires used are EORT ( European Organisation for Research and Treatment of Cancer) QLQ (quality of life questionnaire)-30, QLQ - CR29 and CAX-24 (cancer cachexia-specific questionnaire), and PRT-20 (quality of life questionnaire for proctitis).
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2023
- Study start10 Jun 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- 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
- 194 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mele Maria Cristina, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Investigators
- Maria Cristina Mele, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05938322
- Sponsor's protocol ID
- 5812
- Acronym
- KOMPARC
- Status last verified
- Aug 2025
- First submitted
- 12 Jun 2023
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compliance With Ketogenic Diet in Patients Undergoing Radiotherapy for Pelvic Cancers: a Prospective, Randomized, Mono-centric Study
- ClinicalTrials.gov ID
- NCT05938322
- Acronym / sponsor ID
- KOMPARC / 5812
- Conditions
- Rectal Cancer
- Keywords
- Rectal Cancer, Ketogenic Diet
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 194 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 10 Jun 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 10 Jul 2023 (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.
Patients with locally advanced non-metastatic adenocarcinoma of the rectum undergoing chemoradiation therapy will be assigned to 2 groups:
- the intervention group will be prescribed an individualized ketogenic eating plan to be followed throughout the treatment period
- the control group will be prescribed a diet therapy plan treatment following the international guidelines of clinical nutrition, also to be followed during treatment
Detailed description
Some days before the start of radiotherapy there will be the first visit in which patients will be enrolled and placed in one of the following two groups:
- The intervention group (KD) will be prescribed a ketogenic diet therapy plan characterized by the following composition: carbohydrates < 30g/day, 1.2g-1.5g protein/kg/day and lipids > 65%.
- The control group (SD) will be prescribed a nutrition plan based on the Mediterranean diet model according to ESPEN guidelines (carbohydrates 45-55%, protein 15-20% and lipids 30-35%) There will then be two additional follow-ups for patients: one during the period of therapy and one at the end of therapy.
Compliance with diet therapy treatment (SD vs. KD) will be assessed by analysis of a food diary that the patient will be asked to complete.
During follow-ups it will be assessed:
- BMI and body composition (by bioimpedance analysis)
- Muscle strength and physical performance (by hand grip test and sit-to-stand test) Compliance with and toxicity of radiochemotherapy treatment will be assessed at the radiochemotherapy visits (3 visits during treatment)
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketogenic Diet | Experimental | Other: Ketogenic DietIn the group of intervention is prescribed a ketogenic diet plan. |
| Standard Diet | Active comparator | Other: Standard DietThe control group (SD) will follow the Mediterranean diet pattern based on ESPEN (European Society of Parenteral and Enteral Nutrition) guidelines |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histologic confirmation of rectal adenocarcinoma
- Locally advanced rectal cancer
- Patients undergoing neoadjuvant radiotherapy treatment
- Signature of informed consent to the processing of personal data
Key exclusion criteria (7 listed)
- Severely malnourished patients according to GLIM (Global Leadership Initiative on Malnutrition) criteria
- Patients treated for palliative purposes
- Patients with metastatic disease
- Diabetes mellitus
- Pregnancy or lactation
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 |
|---|---|---|
| Ketogenic DietIn the group of intervention is prescribed a ketogenic diet plan characterized by the following composition: carbohydrates < 30g/day, 1.2g-1.5g protein/kg/day and lipids > 65%. This diet will be followed during the period of treatment with chemo-radiotherapy (5 weeks) | Other | Ketogenic Diet |
| Standard DietThe control group (SD) will follow the Mediterranean diet pattern based on ESPEN guidelines (carbohydrates 45-55%, protein 15-20% and lipids 30-35%). | Other | Standard Diet |
Primary outcome
Adherence to the ketogenic diet
Time frame: 2 months
The primary objective is to assess the adherence to the diet therapy treatment plan (SD vs. KD). It will be verified through a food diary that will be given to the patient during the first visit. The patients will fill out the questionnaire and return it at future visits.
7 secondary outcomes
Assessment of fat mass (FM) in the group of patients on ketogenic diet (KD) compared with the control group
Time frame: 2 months
Evaluation of maintenance of metabolically active mass (BCM) in the group of patients on ketogenic diet (KD) compared with the control group
Time frame: 2 months
Investigate the impact of BCM maintenance on metabolic, inflammatory, hematologic and endocrine response
Time frame: 2 months
Evaluation of the correlation between ketogenic diet (KD) and metabolic, inflammatory, hematologic and endocrine response
Time frame: 2 months
Evaluation of the tolerability to the treatment
Time frame: 2 months
Evaluation of the response to the treatment
Time frame: 2 months
Investigate indices of quality of life
Time frame: 2 months
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 5 Sep 2025.
- Individual participant dataSharing planned: No
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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.
Maria Cristina Mele principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketogenic Diet and Standard Diet in people with Rectal Cancer, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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 4 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: looking for participants now, as of the sponsor's last update on 5 Sep 2025. 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 Italy. 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 Maria Cristina Mele, MD (00390630156772, mariacristina.mele@unicatt.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to the ketogenic diet (time frame: 2 months). 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 5 Sep 2025.