Colorectal CancerHemcancerNCT00994526
Processed Meat and Colon Carcinogenesis
A study testing Ham, Ham + calcium and Ham + vitamin E in people with Colorectal Cancer, run by Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement at 1 site in France.
Trial summary
Colorectal cancer kills forty five people in France every day. Epidemiological studies suggest that two cases out of three could be prevented and show that processed meat intake is a consistent risk factor. Read more about this study
- Who is it for?
- Ages 40 to 75 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Ham, Ham + calcium and Ham + vitamin E
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2009to Jan 2010
- 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 75 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male
- Body mass index 20 <= BMI <= 30 kg/m2
- Affiliated to French National Health Insurance
- Subject giving his written informed consent
- Subject considered as normal after clinical examination and medical questionnaire
Who cannot join
- Positive serologies to HIV or HCV, determined on blood samples
- Previous medical and/or surgery judged by the investigator as incompatible with this study
- Previous familial of colon, ovarian or breast cancer
- Chronic pathologies : cardiovascular diseases, cancer, chronic inflammation diseases, renal, intestinal impairments
- Dislike ham
- Heavy consumer of alcohol
Show all 11Show fewer
- Practising intensive physical exercise
- Being under someone's supervision
- Refusal to be registered on the National Volunteers Data file
- Dietary habits unreliable to controlled food intake
- Being in exclusion on the National Volunteers Data file
Trial locations and contacts
1 site in 1 country.
France1 site
Centre de Recherche en Nutrition Humaine d'Auvergne
Clermont-Ferrand, 63009
About this study
Official title: Effect of Processed Meat on Colorectal Carcinogenesis. Study of Mechanisms. Choice of Preventive Strategies
Colorectal cancer kills forty five people in France every day. Epidemiological studies suggest that two cases out of three could be prevented and show that processed meat intake is a consistent risk factor. The aim of this study is to understand how meat promotes cancer, to find protective strategies, and to make compelling dietary recommendations.
Read the detailed description
18 healthy volunteers will be randomized and will start the study. The study will last 4 weeks for each subject. The first week will be a week of adaptation (or run-in period) to the diet which they will have to follow for the duration of study. During this period, they will collect 2 samples of stools and urine. Then subjects will alternate 4 days of diet either with ham, or with ham and calcium, or with ham enriched with vitamin E. At least, 3 days will separate every period (wash-out) of nutritional intervention. Urines and stools will be collected last 3 days of every interventional period and also last day of every wash out period.
- Conditions
- Colorectal Cancer
- Being tested
- Ham, Ham + calcium, Ham + vitamin E
- Keywords
- Colorectal cancer, Processed meat, Calcium, Vitamin E, Preventive strategies
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HamOther
Ham : 180 g per day during 4 days
Ham + calciumOther
Ham : 160g/d during 4 days calcium : 1000mg/d during 4 days
Ham + vitamin EOther
Ham : 160g/d during 4 days Vitamin E : 80 mg/d during 4 days
| Study group | Role | What they receive |
|---|---|---|
| Ham | Placebo comparator | Not described Receives: Other: Ham |
| Ham + calcium | Experimental | Not described Receives: Other: Ham + calcium |
| Ham + vitamin E | Experimental | Not described Receives: Other: Ham + vitamin E |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary biomarker (DHN-MA:dihydroxynonene mercapturic acid), will be measured before and after every interventional period
Measured: Twice a week, before and after every 4 days of interventional period
Secondary outcomes (1)
Fecal biomarkers
Measured: twice a week, before and after every 4 days of interventional period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionDec 2009
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
- Sponsor type
- University, hospital or other
- Collaborators
- Centre de Recherche en Nutrition Humaine d'Auvergne
- Responsible party
- Principal investigator, Nathalie Meunier, University Hospital, Clermont-Ferrand
- Investigators
- Noël Cano, MD, PhD, Principal investigator, University Hospital, Clermont-FerrandFabrice Pierre, PhD, Study director, Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00994526
- Sponsor's protocol ID
- AU794
- Other IDs
- IDRCB 2009-A00322-55, 04/2009 FPIERRE
- Acronym
- Hemcancer
- Status last verified
- Dec 2012
- First submitted
- 9 Oct 2009
- Last updated
- 17 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Pierre FH, Martin OC, Santarelli RL, Tache S, Naud N, Gueraud F, Audebert M, Dupuy J, Meunier N, Attaix D, Vendeuvre JL, Mirvish SS, Kuhnle GC, Cano N, Corpet DE. Calcium and alpha-tocopherol suppress cured-meat promotion of chemically induced colon carcinogenesis in rats and reduce associated biomarkers in human volunteers. Am J Clin Nutr. 2013 Nov;98(5):1255-62. doi: 10.3945/ajcn.113.061069. Epub 2013 Sep 11.
PubMed 24025632
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Processed Meat on Colorectal Carcinogenesis. Study of Mechanisms. Choice of Preventive Strategies
- ClinicalTrials.gov ID
- NCT00994526
- Acronym / sponsor ID
- Hemcancer / AU794
- Conditions
- Colorectal Cancer
- Keywords
- Colorectal cancer, Processed meat, Calcium, Vitamin E, Preventive strategies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Institut National de Recherche pour l'Agriculture, l'Alimentation et l'EnvironnementUniversity, hospital or other
- Collaborators
- Centre de Recherche en Nutrition Humaine d'Auvergne
- Study start
- Oct 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 14 Oct 2009 (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.
Colorectal cancer kills forty five people in France every day. Epidemiological studies suggest that two cases out of three could be prevented and show that processed meat intake is a consistent risk factor. The aim of this study is to understand how meat promotes cancer, to find protective strategies, and to make compelling dietary recommendations.
Detailed description
18 healthy volunteers will be randomized and will start the study. The study will last 4 weeks for each subject. The first week will be a week of adaptation (or run-in period) to the diet which they will have to follow for the duration of study. During this period, they will collect 2 samples of stools and urine. Then subjects will alternate 4 days of diet either with ham, or with ham and calcium, or with ham enriched with vitamin E. At least, 3 days will separate every period (wash-out) of nutritional intervention. Urines and stools will be collected last 3 days of every interventional period and also last day of every wash out period.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ham | Placebo comparator | Other: Ham |
| Ham + calcium | Experimental | Other: Ham + calcium |
| Ham + vitamin E | Experimental | Other: Ham + vitamin E |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male
- Body mass index 20 <= BMI <= 30 kg/m2
- Affiliated to French National Health Insurance
- Subject giving his written informed consent
- Subject considered as normal after clinical examination and medical questionnaire
Key exclusion criteria (11 listed)
- Positive serologies to HIV or HCV, determined on blood samples
- Previous medical and/or surgery judged by the investigator as incompatible with this study
- Previous familial of colon, ovarian or breast cancer
- Chronic pathologies : cardiovascular diseases, cancer, chronic inflammation diseases, renal, intestinal impairments
- Dislike ham
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 |
|---|---|---|
| HamHam : 180 g per day during 4 days | Other | Ham |
| Ham + calciumHam : 160g/d during 4 days calcium : 1000mg/d during 4 days | Other | Ham + calcium |
| Ham + vitamin EHam : 160g/d during 4 days Vitamin E : 80 mg/d during 4 days | Other | Ham + vitamin E |
Primary outcome
Urinary biomarker (DHN-MA:dihydroxynonene mercapturic acid), will be measured before and after every interventional period
Time frame: Twice a week, before and after every 4 days of interventional period
1 secondary outcome
Fecal biomarkers
Time frame: twice a week, before and after every 4 days of interventional period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2012.
- Derived from this study: PubMed 24025632Pierre FH, Martin OC, Santarelli RL, Tache S, Naud N, Gueraud F, Audebert M, Dupuy J, Meunier N, Attaix D, Vendeuvre JL, Mirvish SS, Kuhnle GC, Cano N, Corpet DE. Calcium and alpha-tocopherol suppress cured-meat promotion of chemically induced colon carcinogenesis in rats and reduce associated biomarkers in human volunteers. Am J Clin Nutr. 2013 Nov;98(5):1255-62. doi: 10.3945/ajcn.113.061069. Epub 2013 Sep 11.
- Related InfoLink provided by the sponsor.
Related trials for Colorectal Cancer
RecruitingPhase 1/2
A Clinical Study of MK-2870 Alone or With Other Treatments to Treat Gastrointestinal Cancers (MK-9999-02A)
Colorectal Cancer, Pancreatic Ductal Adenocarcinoma
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingObservational study
The French Gut-colo
Patients Aged 50-75 and Requiring Colonoscopy
RecruitingEarly Phase 1
Neuroprotective Potential of Cannabidiol (CBD) in Preventing Oxaliplatin (Ox)-Induced Neuropathy
Oxaliplatin Induced Peripheral Neuropathy in Cancer Patients, Metastatic Colorectal Cancer (CRC)
RecruitingPhase 1
Individual Response to Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Treatment of Peritoneal Carcinomatosis From Peritoneal Mesothelioma or Atypical Mesothelial Proliferation or From Ovarian, Colorectal, or Appendiceal Histologies
Peritoneal Mesothelioma, Peritoneal Carcinomatosis
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.
Noël Cano, MD, PhD principal investigator
University Hospital, Clermont-Ferrand
Fabrice Pierre, PhD study director
Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ham, Ham + calcium and Ham + vitamin E in people with Colorectal Cancer, run by Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement at 1 site in France.
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 5 inclusion and 11 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: finished, as of the sponsor's last update on 17 Dec 2012. 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 France. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Urinary biomarker (DHN-MA:dihydroxynonene mercapturic acid), will be measured before and after every interventional period (time frame: Twice a week, before and after every 4 days of interventional period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00994526, which also lists 1 linked publication.
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 17 Dec 2012.