Colonic NeoplasmsCITOGENEX PANCT01477866
Utility Of Citogenex Administration In Patients With Colon-Rectal Cancer
A study testing citogenex and conventional therapy in people with Colonic Neoplasms, run by University of Palermo at 1 site in Italy.
Trial summary
The main aim of the present study is to test the efficacy and safety of CITOGENEX administration in patients with colon-rectal cancer. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Colonic Neoplasms
- What is being tested?
- citogenex and conventional therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteItaly
- Study dates
- Start not givento not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- stage IIIa-IIIc (AJCC/TNM)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
The main aim of the present study is to test the efficacy and safety of CITOGENEX administration in patients with colon-rectal cancer.
Read the detailed description
CITOGENEX is a dietary supplement of insoluble polysaccharides, of Lactobacillus Casei (specific type) and of Bifidobacterium Lactis (specific type). These subspecies of probiotics bacteria have been shown to be effective in improving the immunity. Several trials are currently underway, in order to evaluate the effects of probiotics as potential novel therapies in addition to traditional therapeutic approaches. Although probiotics do not play an anti-tumor action per se, these agents may significantly contribute to decrease the typical side effects due to traditional anti-tumor treatments, such as gastrointestinal symptoms, immunity deficit, as well as the alterations in the gut lymphoid tissue.
It is therefore expected that CITOGENEX may have several significant beneficial effects in patients under anti-tumor treatments. In order to test this hypothesis, we will perform a randomized, single-blind, two-arms, prospective study in patients with colon-rectal cancer.
- Conditions
- Colonic Neoplasms
- Being tested
- citogenex, conventional therapy
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
citogenexDietary supplement
CITOGENEX is a dietary supplement of insoluble polysaccharides, of Lactobacillus Casei (specific type) and of Bifidobacterium Lactis (specific type).
conventional therapyOther
conventional therapy for colon-rectal cancer
| Study group | Role | What they receive |
|---|---|---|
| citogenex | Experimental | citogenex + conventional therapy Receives: Dietary Supplement: citogenex; Other: conventional therapy |
| conventional therapy | Active comparator | conventional therapy Receives: Other: conventional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
All cause mortality
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2011 (estimated)
Why it stopped: the study has never started
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonic NeoplasmsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Palermo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manfredi Rizzo, University of Palermo
- Investigators
- Giovanni Tomasello, MD, Study director, University of PalermoFrancesco Cappello, MD, Study chair, University of PalermoProvvidenza Damiani, MD, Principal investigator, University of PalermoManfredi Rizzo, MD, Principal investigator, University of Palermo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01477866
- Sponsor's protocol ID
- CITOGENEX CRC
- Acronym
- CITOGENEX PA
- Status last verified
- Dec 2017
- First submitted
- 18 Nov 2011
- Last updated
- 12 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utility Of Citogenex Administration In Patients With Colon-Rectal Cancer
- ClinicalTrials.gov ID
- NCT01477866
- Acronym / sponsor ID
- CITOGENEX PA / CITOGENEX CRC
- Conditions
- Colonic Neoplasms
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: the study has never started
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University of PalermoUniversity, hospital or other
- First posted
- 23 Nov 2011 (estimated)
- 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.
The main aim of the present study is to test the efficacy and safety of CITOGENEX administration in patients with colon-rectal cancer.
Detailed description
CITOGENEX is a dietary supplement of insoluble polysaccharides, of Lactobacillus Casei (specific type) and of Bifidobacterium Lactis (specific type). These subspecies of probiotics bacteria have been shown to be effective in improving the immunity. Several trials are currently underway, in order to evaluate the effects of probiotics as potential novel therapies in addition to traditional therapeutic approaches. Although probiotics do not play an anti-tumor action per se, these agents may significantly contribute to decrease the typical side effects due to traditional anti-tumor treatments, such as gastrointestinal symptoms, immunity deficit, as well as the alterations in the gut lymphoid tissue.
It is therefore expected that CITOGENEX may have several significant beneficial effects in patients under anti-tumor treatments. In order to test this hypothesis, we will perform a randomized, single-blind, two-arms, prospective study in patients with colon-rectal cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| citogenex | Experimental | Dietary Supplement: citogenex, Other: conventional therapycitogenex + conventional therapy |
| conventional therapy | Active comparator | Other: conventional therapyconventional therapy |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- stage IIIa-IIIc (AJCC/TNM)
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| citogenexCITOGENEX is a dietary supplement of insoluble polysaccharides, of Lactobacillus Casei (specific type) and of Bifidobacterium Lactis (specific type). | Dietary supplement | citogenex |
| conventional therapyconventional therapy for colon-rectal cancer | Other | citogenex, conventional therapy |
Primary outcome
All cause mortality
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2017.
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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. This study is not recruiting at the moment.
Giovanni Tomasello, MD study director
University of Palermo
Francesco Cappello, MD study chair
University of Palermo
Provvidenza Damiani, MD principal investigator
University of Palermo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing citogenex and conventional therapy in people with Colonic Neoplasms, run by University of Palermo 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 1 inclusion and 0 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: paused, as of the sponsor's last update on 12 Dec 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All cause mortality (time frame: 2 years). 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 12 Dec 2017.