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SCENT part 3. Acute effects on smellprints of chemotherapy in patients with lung cancer.


- candidate number4830
- NTR NumberNTR1607
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR29-dec-2008
- Secondary IDs589 TPO
- Public TitleSCENT part 3. Acute effects on smellprints of chemotherapy in patients with lung cancer.
- Scientific TitleSmellprints in lung Cancer; the role of ENose in diagnosis and Treatment (SCENT): part 3. Acute effects on smellprints of chemotherapy in patients with lung cancer.
- ACRONYMSCENT (study 3)
- hypothesisWe hypothesize that chemotherapy-induced changes in exhaled metabolites in lung cancer can be detected by changes in VOC profiles (smell-prints) measured by the eNose.
- Healt Condition(s) or Problem(s) studiedLung cancer
- Inclusion criteria1. Informed consent is obtained;
2. newly diagnosed adenocarcinoma or squamous cell carcinoma stage IIIA, IIIB or IV or small cell lung cancer);
3. adults 18-80 years;
4. scheduled for chemotherapy as first part of the treatment:
Cisplatin/Gemcitabine (NSCLC) and Cisplatin/Etoposide (SCLC).
- Exclusion criteria1. Previous chemotherapy;
2. unable to evaluate response with the RECIST criteria;
3. unable to follow the instructions for the eNose measurement.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 2-jan-2009
- planned closingdate31-dec-2011
- Target number of participants75
- InterventionsN/A
- Primary outcomeThe primary objective is to investigate whether the eNose can discriminate the smellprints obtained before and after 1 cycle of chemotherapy in patients with specific histological types of lung cancer (NSCLC: adenocarcinoma, squamous cell carcinoma and SCLC).
- Secondary outcomeThe secondary objectives are:
1. To investigate whether the eNose can discriminate between the baseline smellprints of patients with different histological types of lung cancer (NSCLC: adenocarcinoma, squamous cell carcinoma and SCLC);
2. To investigate whether the pre-chemotherapy smellprint is related to:
a. the stage of the disease according to the stage grouping of the Mountain classification (NSCLC) [21] or division into LD or ED (SCLC) [2];
b. metabolic activity of the disease as assessed by Standard Uptake Value (SUV) on PET-CT scan;
3. To investigate whether the potential change in smellprint after 1 cycle of chemotherapy is related to tumour response (determined after the second cycle of chemotherapy) according to the RECIST criteria.
- TimepointsDay 1(before first cycle of chemotherapy), day 15 (after chemo) and day 22 (just before second chemo).
- Trial web siteN/A
- statusstopped
- CONTACT FOR PUBLIC QUERIES J. Maten, van der
- CONTACT for SCIENTIFIC QUERIES J. Maten, van der
- Sponsor/Initiator Medical Center Leeuwarden
- Funding
(Source(s) of Monetary or Material Support)
Medisch Centrum Leeuwarden
- PublicationsN/A
- Brief summaryTherefore in the present study, we hypothesize that chemotherapy-induced changes in exhaled metabolites in lung cancer can be detected by changes in VOC profiles (smell-prints) measured by the eNose.


Objectives:
1. The primary objective of this study is to investigate whether the eNose can discriminate the smellprints obtained before and after 1 cycle of chemotherapy in patients with specific histological types of lung cancer (NSCLC: adenocarcinoma, squamous cell carcinoma and SCLC);
2. The secondary objectives are:
a. To investigate whether the eNose can discriminate between the baseline smellprints of patients with different histological types of lung cancer (NSCLC: adenocarcinoma, squamous cell carcinoma and SCLC);
b. To investigate whether the baseline smellprint (pre chemotherapy) is related to
i. the stage of the disease according to the stage grouping of the Mountain classification (NSCLC) [21] or division into LD or ED (SCLC) [2].
ii. metabolic activity of the disease as assessed by Standard Uptake Value (SUV) on PET-CT scan.
c. To investigate whether the potential change in smellprint after 1 cycle of chemotherapy is related to tumour response (determined after the second cycle of chemotherapy) as assessed by changes in tumour size and classified according to the RECIST criteria.

Study design:
prospective, observational study.
Scheme:
0 1 15 22 (day) I___I chemotherapyI_________________I________________I 1 2 3 (visit) At the Pulmonary Function Department each participant will follow this sequence per visit:
1. questionnaire;
2. exhaled breath collection;
3. spirometry.


1. STUDY POPULATION;
1.1 Population;
Patients with newly diagnosed adenocarcinoma or squamous cell carcinoma stage IIIA, IIIB or IV or small cell lung cancer who are scheduled for their first cycle of chemotherapy at the department of pulmonary diseases.

1.2 Inclusion criteria;
-Informed consent is obtained.
-newly diagnosed adenocarcinoma or squamous cell carcinoma stage IIIA, IIIB or IV or small cell lung cancer).
-Adults 18-80 years.
-scheduled for chemotherapy as first part of the treatment:
Cisplatin/Gemcitabine (NSCLC) and Cisplatin/Etoposide (SCLC).


1.3 Exclusion criteria;
-Previous chemotherapy;
-unable to evaluate response with the RECIST criteria;
-unable to follow the instructions for the eNose measurement.


1.4 Sample size calculation.
This is an observational study with descriptive statistic analysis. The sample size was calculated for the primary question whether the eNose measurements (smellprints) change during the first chemotherapy cycle. Our intention is to have at least 80% power for the case that the mean difference between the eNose measurements at baseline and after the first chemotherapy cycle is 0.5 SD or more. This is achieved when we include 25 patients per group or more.
- Main changes (audit trail)
- RECORD29-dec-2008 - 6-mei-2011


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