Colorectal Cancer MetastaticPhase 2PaSToNCT03167268
Panitumumab Skin Toxicity Prevention Trial
A Phase 2 study testing Lycopene in people with Colorectal Cancer Metastatic and Skin Toxicity, run by Ospedale San Carlo Borromeo at 1 site in Italy.
Trial summary
Background and rationale: EGFR represents the main and more studied signal activation pathway in the development of colorectal carcinoma. KRAS, NRAS, BRAF and PI3KA mutations and ERBB2 and MET amplification are responsible for most of the cases of primary resistance to anti-EGFR antibody treatments. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer Metastatic, Skin Toxicity
- What is being tested?
- Lycopene
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteItaly
- Study dates
- 3 Aug 2016to 30 Nov 2021
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years;
- Patients suffering from colorectal adenocarcinoma at stage-IV, for which a treatment with panitumumab is required;
- No previous treatment with anti-EGFR drugs;
- Presence of at least one neoplastic lesion one-dimensionally measurable;
- No systemic anti-neoplastic therapy, nor experimental therapy or radiotherapy during the three weeks before randomization;
- Proper contraceptive treatment by patient and his/her partner;
- Written informed consent for participating to the study;
- Performance Status (under ECOG scale) 0, 1. 2.
Who cannot join
- PS > 2
- Poor patient compliance;
- Dermatological ongoing pathologies which contraindicate the treatment or made skin toxicity assessment difficult;
- Presence of clinical conditions which could alter lycopene absorption (altered intestinal transit, malabsorption);
- Pregnancy;
- Absence of measurable lesions;
- Previous treatment with anti-EGFR drugs;
- Intolerance/allergy to tomato or milk.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double-blind, Phase II Study to Assess the Effectiveness of Lycopene vs Placebo to Reduce Skin Toxicity in Patients With Colorectal Carcinoma Treated With Panitumumab
Background and rationale: EGFR represents the main and more studied signal activation pathway in the development of colorectal carcinoma. KRAS, NRAS, BRAF and PI3KA mutations and ERBB2 and MET amplification are responsible for most of the cases of primary resistance to anti-EGFR antibody treatments. Despite the identification of these resistance mechanisms, a primary resistance to the therapy was detected in a certain percentage of cases, in which tumour bio-molecular characteristics would suggest a possible response to anti-EGFR antibody treatment. In these cases, pathway activation mechanisms should exist, which act in an alternative, complementary or parallel way than the EGFR one, allowing tumour progression despite of EGFR pharmacological deactivation. Skin toxicity is a characteristic of drugs having EGFR as a target and it shows itself mainly as a sterile acneiform folliculitis together with neutrophils perifollicular infiltrates but also as skin xerosis and paronychia starting from the earliest cycles of treatment. This skin toxicity seems to be closely related to EGFR activation of pro-inflammatory cytokines able to activate specific inflammatory activators, which induce neutrophils granulocytes chemotaxis. Lycopene is a compound belonging to carotenoid group, largely contained in tomatoes and their derivatives, which has an extreme antioxidant activity. In Dermatology, prolonged use of β-carotenoids in general and of lycopene in particular in the diet showed to be effective in skin protection from ageing, sunlight and radiotherapy damages because these compounds may accumulate in skin and thus contribute to reduce free radicals and inflammation effects. Moreover, lycopene ability to induce apoptosis and to inhibit cell cycle progression in some types of tumour cells, both in vitro and in vivo, has already been described. Lycopene seems to be able to suppress significantly PCNA (Proliferating cell nuclear antigen, cofactor of DNA polymerase-β) and β-catenin nuclear expression in neoplastic cells, essential substrate of WNT/β-catenin pathway, which is itself closely connected to activating pathways often involved in carcinogenesis of some kinds of tumours, in particular of colorectal carcinoma, like Akt/GSK3β/β-catenin and Hippo pathways. For its proved skin anti-inflammatory activity as powerful free radicals scavenger, lycopene, which accumulates itself specifically in skin, could be effective in reducing anti-EGFR drugs toxicity. Contemporary use of lycopene could have a positive effect on anti-EGFR drugs treatment effectiveness in patients with metastatic colorectal carcinoma due to its ability to interfere with pathways involved in neoplastic cells proliferation.
Estimated population:100 patients (50 for each of the two groups of treatment)
Read more
Study Framework: In this study, patients suffering from metastatic colorectal cancer and submitted to therapy with panitumumab would be enrolled. According to indications, panitumumab would be used:
in first line combined with Folfox or Folfiri;
in second line combined with Folfiri or treatments containing Irinotecan
in monotherapy in any therapeutic line in patients resistant to Fluoropyrimidines, Oxaliplatin and Irinotecan or intolerant to these drugs.
Standard schedules of these treatments would be used.
This is a phase-II, randomized, double-blind study between experimental prophylactic treatment with Lycopene vs placebo:
- Treatment A - lycopene tablets 20 mg
- Treatment B - placebo tablets
Patients should take orally Lycopene/placebo after dinner (to promote its absorption), starting the day before the beginning of treatment with panitumumab for the entire duration of the therapy, until progression of the disease or definitive drug suspension for toxicity.
Objectives of the study
Primary objective: to assess the effectiveness of lycopene versus placebo in reducing skin toxicity induced by panitumumab in patients treated for metastatic colorectal carcinoma.
Secondary objective: to assess lycopene pharmacokinetics
Exploratory objectives: to assess lycopene effectiveness versus placebo in increasing panitumumab effectiveness in terms of Disease Control (DC), Objective Response (OR) and Stabilisation of the Disease (SD). To assess lycopene effectiveness versus placebo in increasing panitumumab effectiveness in terms of Progression Free Survival (PFS).
As far as randomization is concerned, the two groups will be balanced according to sex, therapeutic line and institution in which patients will be treated.
- Conditions
- Colorectal Cancer Metastatic, Skin Toxicity
- Being tested
- Lycopene, Placebo
- Keywords
- Lycopene, Anti EGFR therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LycopeneDrug
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Lycopene 20mg cpr/die | Experimental | Lycopene is a compound belonging to carotenoid group, largely contained in tomatoes and their derivatives, which has an extreme antioxidant activity. In Dermatology, prolonged use of β-carotenoids in general and of lycopene in particular in the diet showed to be effective in skin protection from ageing, sunlight and radiotherapy damages because these compounds may accumulate in skin and thus contribute to reduce free radicals and inflammation effects. Receives: Drug: Lycopene |
| Placebo | Placebo comparator | Containing same excipients than the experimental "Lycopene 20 mg" but not active principle (Lycopene) Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin toxicity reduction
Reduction of grade 2/4 skin toxicity of 30% in the experimental group.
Toxicity will be evaluated as:
- worst toxicity for each patient during the treatment;
- grade 3 or grade 4 toxicity duration related to the treatment duration for each patient in the two arms;
- number and duration of tetracyclines and antibiotic treatment related to the treatment duration for each patient in the two arms;
- toxicity in difference time points (G15, G29, .....) for each clinical skin features (rash papular, pustular - xerosis skin - paronychia) in the two arms
Measured: Skin toxicity will be verified every two weeks assessed up to 12 weeks, from date of randomization until the date of first documented progression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2017
- Study start3 Aug 2016
- Primary completion13 Jan 2020
- Study completion30 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Colorectal Cancer MetastaticStudies 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ospedale San Carlo Borromeo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DR. MAURO MORONI, Ospedale San Carlo Borromeo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03167268
- Sponsor's protocol ID
- PaSTo
- Acronym
- PaSTo
- Status last verified
- Sep 2021
- First submitted
- 27 Feb 2017
- Last updated
- 9 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hu JC, Sadeghi P, Pinter-Brown LC, Yashar S, Chiu MW. Cutaneous side effects of epidermal growth factor receptor inhibitors: clinical presentation, pathogenesis, and management. J Am Acad Dermatol. 2007 Feb;56(2):317-26. doi: 10.1016/j.jaad.2006.09.005. Epub 2006 Dec 1.
PubMed 17141360Galimont-Collen AF, Vos LE, Lavrijsen AP, Ouwerkerk J, Gelderblom H. Classification and management of skin, hair, nail and mucosal side-effects of epidermal growth factor receptor (EGFR) inhibitors. Eur J Cancer. 2007 Mar;43(5):845-51. doi: 10.1016/j.ejca.2006.11.016. Epub 2007 Feb 7.
PubMed 17289377Pastore S, Mascia F, Mariani V, Girolomoni G. The epidermal growth factor receptor system in skin repair and inflammation. J Invest Dermatol. 2008 Jun;128(6):1365-74. doi: 10.1038/sj.jid.5701184. Epub 2007 Nov 29.
PubMed 18049451Rodeck U. Skin toxicity caused by EGFR antagonists-an autoinflammatory condition triggered by deregulated IL-1 signaling? J Cell Physiol. 2009 Jan;218(1):32-4. doi: 10.1002/jcp.21585.
PubMed 18781585Requena C, Llombart B, Sanmartin O. Acneiform eruptions induced by epidermal growth factor receptor inhibitors: treatment with oral isotretinoin. Cutis. 2012 Aug;90(2):77-80.
PubMed 22988651Chen J, Song Y, Zhang L. Effect of lycopene supplementation on oxidative stress: an exploratory systematic review and meta-analysis of randomized controlled trials. J Med Food. 2013 May;16(5):361-74. doi: 10.1089/jmf.2012.2682. Epub 2013 Apr 30.
PubMed 23631493Misale S, Di Nicolantonio F, Sartore-Bianchi A, Siena S, Bardelli A. Resistance to anti-EGFR therapy in colorectal cancer: from heterogeneity to convergent evolution. Cancer Discov. 2014 Nov;4(11):1269-80. doi: 10.1158/2159-8290.CD-14-0462. Epub 2014 Oct 7.
PubMed 25293556Lemieux E, Cagnol S, Beaudry K, Carrier J, Rivard N. Oncogenic KRAS signalling promotes the Wnt/beta-catenin pathway through LRP6 in colorectal cancer. Oncogene. 2015 Sep 17;34(38):4914-27. doi: 10.1038/onc.2014.416. Epub 2014 Dec 15.
PubMed 25500543Kim M, Jho EH. Cross-talk between Wnt/beta-catenin and Hippo signaling pathways: a brief review. BMB Rep. 2014 Oct;47(10):540-5. doi: 10.5483/bmbrep.2014.47.10.177.
PubMed 25154721Kahn M. Can we safely target the WNT pathway? Nat Rev Drug Discov. 2014 Jul;13(7):513-32. doi: 10.1038/nrd4233.
PubMed 24981364Khuda-Bukhsh AR, Das S, Saha SK. Molecular approaches toward targeted cancer prevention with some food plants and their products: inflammatory and other signal pathways. Nutr Cancer. 2014;66(2):194-205. doi: 10.1080/01635581.2014.864420. Epub 2013 Dec 30.
PubMed 24377653Stahl W, Sies H. beta-Carotene and other carotenoids in protection from sunlight. Am J Clin Nutr. 2012 Nov;96(5):1179S-84S. doi: 10.3945/ajcn.112.034819. Epub 2012 Oct 10.
PubMed 23053552Di Franco R, Calvanese M, Murino P, Manzo R, Guida C, Di Gennaro D, Anania C, Ravo V. Skin toxicity from external beam radiation therapy in breast cancer patients: protective effects of Resveratrol, Lycopene, Vitamin C and anthocianin (Ixor(R)). Radiat Oncol. 2012 Jan 30;7:12. doi: 10.1186/1748-717X-7-12.
PubMed 22289566Kasdagly M, Radhakrishnan S, Reddivari L, Veeramachaneni DN, Vanamala J. Colon carcinogenesis: influence of Western diet-induced obesity and targeting stem cells using dietary bioactive compounds. Nutrition. 2014 Nov-Dec;30(11-12):1242-56. doi: 10.1016/j.nut.2014.02.016. Epub 2014 Mar 12.
PubMed 25280404Li Y, Wicha MS, Schwartz SJ, Sun D. Implications of cancer stem cell theory for cancer chemoprevention by natural dietary compounds. J Nutr Biochem. 2011 Sep;22(9):799-806. doi: 10.1016/j.jnutbio.2010.11.001. Epub 2011 Feb 4.
PubMed 21295962
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Phase II Study to Assess the Effectiveness of Lycopene vs Placebo to Reduce Skin Toxicity in Patients With Colorectal Carcinoma Treated With Panitumumab
- ClinicalTrials.gov ID
- NCT03167268
- Acronym / sponsor ID
- PaSTo / PaSTo
- Conditions
- Colorectal Cancer Metastatic, Skin Toxicity
- Keywords
- Lycopene, Anti EGFR therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Ospedale San Carlo BorromeoUniversity, hospital or other
- Study start
- 3 Aug 2016 (actual)
- Primary completion
- 13 Jan 2020 (actual)
- Study completion
- 30 Nov 2021 (estimated)
- First posted
- 25 May 2017 (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.
Background and rationale: EGFR represents the main and more studied signal activation pathway in the development of colorectal carcinoma. KRAS, NRAS, BRAF and PI3KA mutations and ERBB2 and MET amplification are responsible for most of the cases of primary resistance to anti-EGFR antibody treatments. Despite the identification of these resistance mechanisms, a primary resistance to the therapy was detected in a certain percentage of cases, in which tumour bio-molecular characteristics would suggest a possible response to anti-EGFR antibody treatment. In these cases, pathway activation mechanisms should exist, which act in an alternative, complementary or parallel way than the EGFR one, allowing tumour progression despite of EGFR pharmacological deactivation. Skin toxicity is a characteristic of drugs having EGFR as a target and it shows itself mainly as a sterile acneiform folliculitis together with neutrophils perifollicular infiltrates but also as skin xerosis and paronychia starting from the earliest cycles of treatment. This skin toxicity seems to be closely related to EGFR activation of pro-inflammatory cytokines able to activate specific inflammatory activators, which induce neutrophils granulocytes chemotaxis. Lycopene is a compound belonging to carotenoid group, largely contained in tomatoes and their derivatives, which has an extreme antioxidant activity. In Dermatology, prolonged use of β-carotenoids in general and of lycopene in particular in the diet showed to be effective in skin protection from ageing, sunlight and radiotherapy damages because these compounds may accumulate in skin and thus contribute to reduce free radicals and inflammation effects. Moreover, lycopene ability to induce apoptosis and to inhibit cell cycle progression in some types of tumour cells, both in vitro and in vivo, has already been described. Lycopene seems to be able to suppress significantly PCNA (Proliferating cell nuclear antigen, cofactor of DNA polymerase-β) and β-catenin nuclear expression in neoplastic cells, essential substrate of WNT/β-catenin pathway, which is itself closely connected to activating pathways often involved in carcinogenesis of some kinds of tumours, in particular of colorectal carcinoma, like Akt/GSK3β/β-catenin and Hippo pathways. For its proved skin anti-inflammatory activity as powerful free radicals scavenger, lycopene, which accumulates itself specifically in skin, could be effective in reducing anti-EGFR drugs toxicity. Contemporary use of lycopene could have a positive effect on anti-EGFR drugs treatment effectiveness in patients with metastatic colorectal carcinoma due to its ability to interfere with pathways involved in neoplastic cells proliferation.
Estimated population:100 patients (50 for each of the two groups of treatment)
Study Framework: In this study, patients suffering from metastatic colorectal cancer and submitted to therapy with panitumumab would be enrolled. According to indications, panitumumab would be used:
in first line combined with Folfox or Folfiri;
in second line combined with Folfiri or treatments containing Irinotecan
in monotherapy in any therapeutic line in patients resistant to Fluoropyrimidines, Oxaliplatin and Irinotecan or intolerant to these drugs.
Standard schedules of these treatments would be used.
This is a phase-II, randomized, double-blind study between experimental prophylactic treatment with Lycopene vs placebo:
- Treatment A - lycopene tablets 20 mg
- Treatment B - placebo tablets
Patients should take orally Lycopene/placebo after dinner (to promote its absorption), starting the day before the beginning of treatment with panitumumab for the entire duration of the therapy, until progression of the disease or definitive drug suspension for toxicity.
Objectives of the study
Primary objective: to assess the effectiveness of lycopene versus placebo in reducing skin toxicity induced by panitumumab in patients treated for metastatic colorectal carcinoma.
Secondary objective: to assess lycopene pharmacokinetics
Exploratory objectives: to assess lycopene effectiveness versus placebo in increasing panitumumab effectiveness in terms of Disease Control (DC), Objective Response (OR) and Stabilisation of the Disease (SD). To assess lycopene effectiveness versus placebo in increasing panitumumab effectiveness in terms of Progression Free Survival (PFS).
As far as randomization is concerned, the two groups will be balanced according to sex, therapeutic line and institution in which patients will be treated.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lycopene 20mg cpr/die | Experimental | Drug: LycopeneLycopene is a compound belonging to carotenoid group, largely contained in tomatoes and their derivatives, which has an extreme antioxidant activity. In Dermatology, prolonged use of β-carotenoids in general and of lycopene in particular in the diet showed to be effective in skin protection from ageing, sunlight and radiotherapy damages because these compounds may accumulate in skin and thus contribute to reduce free radicals and inflammation effects. |
| Placebo | Placebo comparator | Other: PlaceboContaining same excipients than the experimental "Lycopene 20 mg" but not active principle (Lycopene) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥ 18 years;
- Patients suffering from colorectal adenocarcinoma at stage-IV, for which a treatment with panitumumab is required;
- No previous treatment with anti-EGFR drugs;
- Presence of at least one neoplastic lesion one-dimensionally measurable;
- No systemic anti-neoplastic therapy, nor experimental therapy or radiotherapy during the three weeks before randomization;
Key exclusion criteria (8 listed)
- PS > 2
- Poor patient compliance;
- Dermatological ongoing pathologies which contraindicate the treatment or made skin toxicity assessment difficult;
- Presence of clinical conditions which could alter lycopene absorption (altered intestinal transit, malabsorption);
- Pregnancy;
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 |
|---|---|---|
| Lycopene | Drug | Lycopene 20mg cpr/die |
| Placebo | Other | Placebo |
Primary outcome
Skin toxicity reduction
Time frame: Skin toxicity will be verified every two weeks assessed up to 12 weeks, from date of randomization until the date of first documented progression
Reduction of grade 2/4 skin toxicity of 30% in the experimental group. Toxicity will be evaluated as: 1. worst toxicity for each patient during the treatment; 2. grade 3 or grade 4 toxicity duration related to the treatment duration for each patient in the two arms; 3. number and duration of tetracyclines and antibiotic treatment related to the treatment duration for each patient in the two arms; 4. toxicity in difference time points (G15, G29, .....) for each clinical skin features (rash papular, pustular - xerosis skin - paronychia) in the two arms
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2021.
- Results publication: PubMed 17141360Hu JC, Sadeghi P, Pinter-Brown LC, Yashar S, Chiu MW. Cutaneous side effects of epidermal growth factor receptor inhibitors: clinical presentation, pathogenesis, and management. J Am Acad Dermatol. 2007 Feb;56(2):317-26. doi: 10.1016/j.jaad.2006.09.005. Epub 2006 Dec 1.
- Results publication: PubMed 17289377Galimont-Collen AF, Vos LE, Lavrijsen AP, Ouwerkerk J, Gelderblom H. Classification and management of skin, hair, nail and mucosal side-effects of epidermal growth factor receptor (EGFR) inhibitors. Eur J Cancer. 2007 Mar;43(5):845-51. doi: 10.1016/j.ejca.2006.11.016. Epub 2007 Feb 7.
- Results publication: PubMed 18049451Pastore S, Mascia F, Mariani V, Girolomoni G. The epidermal growth factor receptor system in skin repair and inflammation. J Invest Dermatol. 2008 Jun;128(6):1365-74. doi: 10.1038/sj.jid.5701184. Epub 2007 Nov 29.
- Results publication: PubMed 18781585Rodeck U. Skin toxicity caused by EGFR antagonists-an autoinflammatory condition triggered by deregulated IL-1 signaling? J Cell Physiol. 2009 Jan;218(1):32-4. doi: 10.1002/jcp.21585.
- Results publication: PubMed 22988651Requena C, Llombart B, Sanmartin O. Acneiform eruptions induced by epidermal growth factor receptor inhibitors: treatment with oral isotretinoin. Cutis. 2012 Aug;90(2):77-80.
- Results publication: PubMed 23631493Chen J, Song Y, Zhang L. Effect of lycopene supplementation on oxidative stress: an exploratory systematic review and meta-analysis of randomized controlled trials. J Med Food. 2013 May;16(5):361-74. doi: 10.1089/jmf.2012.2682. Epub 2013 Apr 30.
- Results publication: PubMed 25293556Misale S, Di Nicolantonio F, Sartore-Bianchi A, Siena S, Bardelli A. Resistance to anti-EGFR therapy in colorectal cancer: from heterogeneity to convergent evolution. Cancer Discov. 2014 Nov;4(11):1269-80. doi: 10.1158/2159-8290.CD-14-0462. Epub 2014 Oct 7.
- Results publication: PubMed 25500543Lemieux E, Cagnol S, Beaudry K, Carrier J, Rivard N. Oncogenic KRAS signalling promotes the Wnt/beta-catenin pathway through LRP6 in colorectal cancer. Oncogene. 2015 Sep 17;34(38):4914-27. doi: 10.1038/onc.2014.416. Epub 2014 Dec 15.
- Results publication: PubMed 25154721Kim M, Jho EH. Cross-talk between Wnt/beta-catenin and Hippo signaling pathways: a brief review. BMB Rep. 2014 Oct;47(10):540-5. doi: 10.5483/bmbrep.2014.47.10.177.
- Results publication: PubMed 24981364Kahn M. Can we safely target the WNT pathway? Nat Rev Drug Discov. 2014 Jul;13(7):513-32. doi: 10.1038/nrd4233.
- Results publication: PubMed 24377653Khuda-Bukhsh AR, Das S, Saha SK. Molecular approaches toward targeted cancer prevention with some food plants and their products: inflammatory and other signal pathways. Nutr Cancer. 2014;66(2):194-205. doi: 10.1080/01635581.2014.864420. Epub 2013 Dec 30.
- Results publication: PubMed 23053552Stahl W, Sies H. beta-Carotene and other carotenoids in protection from sunlight. Am J Clin Nutr. 2012 Nov;96(5):1179S-84S. doi: 10.3945/ajcn.112.034819. Epub 2012 Oct 10.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lycopene in people with Colorectal Cancer Metastatic and Skin Toxicity, run by Ospedale San Carlo Borromeo 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 8 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 9 Sep 2021. 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. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Skin toxicity reduction (time frame: Skin toxicity will be verified every two weeks assessed up to 12 weeks, from date of randomization until the date of first documented progression). 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 NCT03167268, which also lists 22 linked publications.
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 9 Sep 2021; AzTrials last refreshed its copy on 2 Nov 2026.