Breast CancerNCT01382667
Plasma Levels of Glucagon-like Peptide-2 and Dyspepsia in Patients With Extraintestinal Cancer During Chemotherapy
An observational study of Breast Cancer and Lung Cancer, run by Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis at 1 site in Italy.
Trial summary
The specific aim of the study is to investigate the relationship between the development of dyspepsia and GI dyspeptic symptoms in relation to circulating levels of peculiar GI peptides (such gastrin, pepsinogen and GLP-2) in patients with non-gastrointestinal neoplasm well controlled for emesis. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Breast Cancer, Lung Cancer, Dyspepsia
- How many people
- 70 participants
- Where
- 1 siteItaly
- Study dates
- Jul 2011to Jan 2012
- Phase
- Observational
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Twenty-five patients who had undergone surgical ablation of the primitive tumour (lung and breast cancer) as definitive primary treatment and attending the Oncology Day Hospital of our Institute,and the IRCCS Oncologico of Bari will be enrolled. They had to be scheduled for adjuvant therapies associated with a standard dosage of antiserotoninergic drugs according to ESMO recommendations
Who may be able to join
- Patients with newly diagnosed cancer (lung and breast cancer),
- Patients currently free of active disease
Who cannot join
- History of cerebral edema, primary and secondary brain neoplasm with signs and symptoms of raised intracranial pressure and/or brain metastases,
- Signs of marked hepatic or renal dysfunction, cardiac failure
- Signs of dyspepsia, peptic ulcer, gastric surgery or prior diagnosis of other cancer
- Administration of drugs interfering with GI motility (i.e. antisecretory, prokinetic, or antibiotic drugs) as well as the exposition to radiotherapy, four weeks prior to the examination
- Referred episode of nausea of any severity within 24 h prior to antiemetic therapy, if they had experienced vomiting in the previous 24 h,
- Pregnancy or lactating
- Concomitant administration of agents known to have significant antiemetic activity, including benzodiazepines and other corticosteroids
Trial locations and contacts
1 site in 1 country.
Italy1 site
National Institute for Digestive Diseases IRCCS "S. de Bellis"
Castellana Grotte, Bari, 70013
About this study
Official title: Evaluation of Dyspeptic Symptoms in Oncological Frail Patients With Extraintestinal Cancer in Chemotherapy. Assessment of Circulating Levels of Glucagon-like Peptide 2 (GLP-2) in Relation to Mucositis
The specific aim of the study is to investigate the relationship between the development of dyspepsia and GI dyspeptic symptoms in relation to circulating levels of peculiar GI peptides (such gastrin, pepsinogen and GLP-2) in patients with non-gastrointestinal neoplasm well controlled for emesis.
Read the detailed description
The complications of anticancer treatment threaten the effectiveness of therapy because they lead to dose reduction, increase healthcare costs, and impair patients' quality of life. Gastrointestinal (GI) symptoms are the most frequent side effects of antineoplastic chemotherapy behind bone-marrow depression, with nausea and vomiting representing the mainly referred ones.
Gastrointestinal (GI) mucositis, which represents injury of the rest of the alimentary tract beyond oral mucositis, is becoming recognized increasingly as a toxicity associated with many standard-dose chemotherapy regimens. Although clinicians consider them "minor complaints", many patients (40-100%) treated with chemotherapy and/or exposed to ionizing radiation suffer from such a disease. After chemotherapy, GI mucositis is most prominent in the small intestine, but it also occurs in the esophagus, stomach, and large intestine. The GI symptoms related to mucositis mimic those from other GI disease (such as dyspepsia, reflux disease or abdominal pain and diarrhea). Alimentary tract mucositis increases morbility and mortality and contribute to rising health care cost.
The comprehension of pathophysiology will shed light on the rationale for targeting specific pathways and so for the use of specific agents for prevention and treatment. Since the role of chemotherapy in the onset of GI motility disorders in addition to minor GI complaints has not been clarified yet. Understanding the pathophysiology of mucositis, its measures and scores, are essential for progress in research and care direct at this common side-effect of anticancer therapy. Currently, there is not strong evidence to support a recommendation for and against the use of certain agents (mucosal surface protectants, antiinflammatory or antimicrobial agents, growth factors, etc).
- Conditions
- Breast Cancer, Lung Cancer, Dyspepsia
- Keywords
- mucositis, dyspepsia, chemotherapy, GLP-2, questionnaire
- Medical subject headings
- Breast Neoplasms, Lung Neoplasms, Dyspepsia, Mucositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| GLP-2 and symptom evaluation | Before starting and at the end of the chemotherapy, along with a blood withdrawal for GLP-2 evaluation, a GSRS (gastrointestinal symptom rate scale) questionnaire will be filled by each patient to account for GI symptoms. In addition, minor complaints such as warm sensation after chemotherapy, susceptibility to nausea under specific condition, sweating and weakness will scored by visual analog score (VAS). Lastly, the NCI-CTC score for mucositis will be performed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
GLP-2 plasma levels in cancer patients
Evaluation of plasma levels of GLP-2 in patients with extraintestinal cancer before and after chemotherapy.
Measured: 21 days
Secondary outcomes (1)
Cancer associated dyspepsia syndrome, mucositis and GLP-2 plasma levels
Evaluation of the symptom profile related to CADS (cancer associated dyspepsia syndrome) before and after the first cycle of chemotherapy.
Assessment of possible relations between mucositis score, gastrointestinal symptom score and GLP-2 plasma levels.
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2011 (estimated)
- Study startJul 2011
- Primary completionDec 2011
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Breast 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesco Russo, Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
- Investigators
- Caterina Clemente, ScD, Principal investigator, National Institute of Digestive Diseases IRCCS "S. de Bellis"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01382667
- Sponsor's protocol ID
- SRLP06
- Status last verified
- Nov 2012
- First submitted
- 24 Jun 2011
- Last updated
- 9 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Riezzo G, Chiloiro M, Russo F, Clemente C, Di Matteo G, Guerra V, Di Leo A. Gastric electrical activity and gastrointestinal hormones in dyspeptic patients. Digestion. 2001;63(1):20-9. doi: 10.1159/000051868.
PubMed 11173896Drucker DJ. Biological actions and therapeutic potential of the glucagon-like peptides. Gastroenterology. 2002 Feb;122(2):531-44. doi: 10.1053/gast.2002.31068.
PubMed 11832466Riezzo G, Clemente C, Leo S, Russo F. The role of electrogastrography and gastrointestinal hormones in chemotherapy-related dyspeptic symptoms. J Gastroenterol. 2005 Dec;40(12):1107-15. doi: 10.1007/s00535-005-1708-7.
PubMed 16378174Peterson DE, Cariello A. Mucosal damage: a major risk factor for severe complications after cytotoxic therapy. Semin Oncol. 2004 Jun;31(3 Suppl 8):35-44. doi: 10.1053/j.seminoncol.2004.04.006.
PubMed 15181607Hesketh PJ, Van Belle S, Aapro M, Tattersall FD, Naylor RJ, Hargreaves R, Carides AD, Evans JK, Horgan KJ. Differential involvement of neurotransmitters through the time course of cisplatin-induced emesis as revealed by therapy with specific receptor antagonists. Eur J Cancer. 2003 May;39(8):1074-80. doi: 10.1016/s0959-8049(02)00674-3.
PubMed 12736106Russo F, Linsalata M, Clemente C, D'Attoma B, Orlando A, Campanella G, Giotta F, Riezzo G. The effects of fluorouracil, epirubicin, and cyclophosphamide (FEC60) on the intestinal barrier function and gut peptides in breast cancer patients: an observational study. BMC Cancer. 2013 Feb 4;13:56. doi: 10.1186/1471-2407-13-56.
PubMed 23379680
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Dyspeptic Symptoms in Oncological Frail Patients With Extraintestinal Cancer in Chemotherapy. Assessment of Circulating Levels of Glucagon-like Peptide 2 (GLP-2) in Relation to Mucositis
- ClinicalTrials.gov ID
- NCT01382667
- Acronym / sponsor ID
- SRLP06
- Conditions
- Breast Cancer, Lung Cancer, Dyspepsia
- Keywords
- mucositis, dyspepsia, chemotherapy, GLP-2, questionnaire
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de BellisUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 27 Jun 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 specific aim of the study is to investigate the relationship between the development of dyspepsia and GI dyspeptic symptoms in relation to circulating levels of peculiar GI peptides (such gastrin, pepsinogen and GLP-2) in patients with non-gastrointestinal neoplasm well controlled for emesis.
Detailed description
The complications of anticancer treatment threaten the effectiveness of therapy because they lead to dose reduction, increase healthcare costs, and impair patients' quality of life. Gastrointestinal (GI) symptoms are the most frequent side effects of antineoplastic chemotherapy behind bone-marrow depression, with nausea and vomiting representing the mainly referred ones.
Gastrointestinal (GI) mucositis, which represents injury of the rest of the alimentary tract beyond oral mucositis, is becoming recognized increasingly as a toxicity associated with many standard-dose chemotherapy regimens. Although clinicians consider them "minor complaints", many patients (40-100%) treated with chemotherapy and/or exposed to ionizing radiation suffer from such a disease. After chemotherapy, GI mucositis is most prominent in the small intestine, but it also occurs in the esophagus, stomach, and large intestine. The GI symptoms related to mucositis mimic those from other GI disease (such as dyspepsia, reflux disease or abdominal pain and diarrhea). Alimentary tract mucositis increases morbility and mortality and contribute to rising health care cost.
The comprehension of pathophysiology will shed light on the rationale for targeting specific pathways and so for the use of specific agents for prevention and treatment. Since the role of chemotherapy in the onset of GI motility disorders in addition to minor GI complaints has not been clarified yet. Understanding the pathophysiology of mucositis, its measures and scores, are essential for progress in research and care direct at this common side-effect of anticancer therapy. Currently, there is not strong evidence to support a recommendation for and against the use of certain agents (mucosal surface protectants, antiinflammatory or antimicrobial agents, growth factors, etc).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GLP-2 and symptom evaluation | – | –Before starting and at the end of the chemotherapy, along with a blood withdrawal for GLP-2 evaluation, a GSRS (gastrointestinal symptom rate scale) questionnaire will be filled by each patient to account for GI symptoms. In addition, minor complaints such as warm sensation after chemotherapy, susceptibility to nausea under specific condition, sweating and weakness will scored by visual analog score (VAS). Lastly, the NCI-CTC score for mucositis will be performed. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Twenty-five patients who had undergone surgical ablation of the primitive tumour (lung and breast cancer) as definitive primary treatment and attending the Oncology Day Hospital of our Institute,and the IRCCS Oncologico of Bari will be enrolled. They had to be scheduled for adjuvant therapies associated with a standard dosage of antiserotoninergic drugs according to ESMO recommendations
Key inclusion criteria (2 listed)
- Patients with newly diagnosed cancer (lung and breast cancer),
- Patients currently free of active disease
Key exclusion criteria (7 listed)
- History of cerebral edema, primary and secondary brain neoplasm with signs and symptoms of raised intracranial pressure and/or brain metastases,
- Signs of marked hepatic or renal dysfunction, cardiac failure
- Signs of dyspepsia, peptic ulcer, gastric surgery or prior diagnosis of other cancer
- Administration of drugs interfering with GI motility (i.e. antisecretory, prokinetic, or antibiotic drugs) as well as the exposition to radiotherapy, four weeks prior to the examination
- Referred episode of nausea of any severity within 24 h prior to antiemetic therapy, if they had experienced vomiting in the previous 24 h,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
GLP-2 plasma levels in cancer patients
Time frame: 21 days
Evaluation of plasma levels of GLP-2 in patients with extraintestinal cancer before and after chemotherapy.
1 secondary outcome
Cancer associated dyspepsia syndrome, mucositis and GLP-2 plasma levels
Time frame: 21 days
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 9 Nov 2012.
- Background: PubMed 11173896Riezzo G, Chiloiro M, Russo F, Clemente C, Di Matteo G, Guerra V, Di Leo A. Gastric electrical activity and gastrointestinal hormones in dyspeptic patients. Digestion. 2001;63(1):20-9. doi: 10.1159/000051868.
- Background: PubMed 11832466Drucker DJ. Biological actions and therapeutic potential of the glucagon-like peptides. Gastroenterology. 2002 Feb;122(2):531-44. doi: 10.1053/gast.2002.31068.
- Background: PubMed 16378174Riezzo G, Clemente C, Leo S, Russo F. The role of electrogastrography and gastrointestinal hormones in chemotherapy-related dyspeptic symptoms. J Gastroenterol. 2005 Dec;40(12):1107-15. doi: 10.1007/s00535-005-1708-7.
- Background: PubMed 15181607Peterson DE, Cariello A. Mucosal damage: a major risk factor for severe complications after cytotoxic therapy. Semin Oncol. 2004 Jun;31(3 Suppl 8):35-44. doi: 10.1053/j.seminoncol.2004.04.006.
- Background: PubMed 12736106Hesketh PJ, Van Belle S, Aapro M, Tattersall FD, Naylor RJ, Hargreaves R, Carides AD, Evans JK, Horgan KJ. Differential involvement of neurotransmitters through the time course of cisplatin-induced emesis as revealed by therapy with specific receptor antagonists. Eur J Cancer. 2003 May;39(8):1074-80. doi: 10.1016/s0959-8049(02)00674-3.
- Derived from this study: PubMed 23379680Russo F, Linsalata M, Clemente C, D'Attoma B, Orlando A, Campanella G, Giotta F, Riezzo G. The effects of fluorouracil, epirubicin, and cyclophosphamide (FEC60) on the intestinal barrier function and gut peptides in breast cancer patients: an observational study. BMC Cancer. 2013 Feb 4;13:56. doi: 10.1186/1471-2407-13-56.
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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.
Caterina Clemente, ScD principal investigator
National Institute of Digestive Diseases IRCCS "S. de Bellis"
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Lung Cancer, run by Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis 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 2 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: finished, as of the sponsor's last update on 9 Nov 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 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?
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?
GLP-2 plasma levels in cancer patients (time frame: 21 days). 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 NCT01382667, which also lists 6 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 Nov 2012.