- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01809756
The Effect of Caphosol® on the Development of Esophagitis in (N)SCLC Patients Treated With Concurrent Chemo/Radiotherapy (CARACTER)
The Effect of Caphosol® on the Development of Esophagitis in (N)SCLC Patients Treated With Concurrent Chemo/Radiotherapy A Prospective Study of Caphosol + Standard of Care Versus Standard of Care
Rationale: In the Netherlands 1770 people are being diagnosed with SCLC (Small Cell Lung Cancer) and 8764 patients are being diagnosed with NSCLC (Non Small Cell Lung Cancer) in 2011. This is approximately 15% and 75% of all new diagnosed lungcancers. Part of them will need a combination of chemo-radiationtherapy. A review of the incidence and severity of esophagitis in (N)SCLC patients receiving a combination of chemotherapy and once daily radiotherapy revealed overall esophagitis rates up to 58% experiencing esophagitis grade 2 and higher. As concurrent radiotherapy is moving to twice daily radiation (30 x 1,5 Gy in 3 weeks or 30-35 x 2 Gy in 3 weeks) it is expected that the incidence of esophagitis will rise, the clinical symptoms are likely to arise earlier and become more severe.
Mucositis of the upper tractus digestivus is a serious adverse event leading to pain, problems with swallowing and decreased food intake. It has a negative infect on QoL and can lead to prolonged hospital stay and delayed cancer treatment. Physicians seek improvements in treatment modalities to improve these daily patient toxicities.
Caphosol® is an advanced electrolyte solution indicated as an adjunct to standard oral care in treating oral mucositis caused by radiation or high dose chemotherapy. Positive effects of Caphosol® oral rinse 4 times daily in a study with head and neck chemoradiation patients were found on the presence of mucositis and on oral comfort.
It's supposed that the pathogenesis of chemo- or radiotherapy induced mucositis is the same for the whole tractus digestivus. The appearance does differ due to differences in cell proliferation.
Swallowing Caphosol® after oral rinse could have a positive effect on esophageal mucositis on time of onset, severity and duration.
Objective: Adding the use of Caphosol® (rinsing and swallowing four times a day) to the standard of care for esophagitis/mucositis, reduces the incidence, onset, duration and severity of esophagitis in (N)SCLC patients, comparing to the standard of care alone.
Study design: A multi-centre, open, randomized prospective phase II study. Study population: 108 patients 18 years or older with histologically proven (N)SCLC (all histological subtypes), treated with concurrent chemo- and radiotherapy are estimated to be included in this study (2:1 ratio inclusion; 72 patients with Caphosol® and 36 patients without Caphosol®; α=0.05, power 80%).
Intervention (if applicable): 108 patients eligible for this study will be monitored during their (N)SCLC chemo/radiotherapy treatment. One group of 72 patients will receive Caphosol®, 4 times a day - next to the standard of care. Caphosol® will start at day 1 of treatment and will be continued until 3 weeks after the last radiotherapy (RT).Another group of 36 patients will receive only the current standard of care for esophagitis. The patients will be randomly assigned to one of the groups.
Main study parameters/endpoints: The primary objective is to estimate the incidence, onset, duration and severity of esophagitis in (N)SCLC patients undergoing radiation therapy with chemotherapy who receive Caphosol®.
Secondary study parameters/outcome of the study (if applicable):
- To correlate components of esophagitis data with clinical outcomes (pain, dysphagia, analgetic use, oral intake, weight loss, infection, need for hospitalization, QoL)
- Discontinuation or delay of chemotherapy due to esophagitis. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The risks are very small. The patient has to fill in a Esophagitis Daily Questionnaire and during regular visits QOL questionaires are performed.
Sputumswabs are collected on a weekly basis for determination of the microbiological flora of the mouth. During regular blood control max. 8 ml extra blood is taken for immunologic status research.
Caphosol® is a saturated calciumphosphate solution. The daily intake of calcium and phosphor when swallowing Caphosol® 4 times daily is far beyond the Acceptable Daily Intake (ADI)(< 5%). Compared to daily nutrients like milk (270 mg calcium per unit milk (225 ml)) or meat (200 mg phosphor per 100 g meat) the intake of calcium and phosphor due to Caphosol® is negligible and is considered safe.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Rotterdam, Netherlands, 3015AA
- Erasmus Medical Centre
-
-
Noord-Brabant
-
Breda, Noord-Brabant, Netherlands, 4818 CK
- Amphia Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 18 years or older
- Patients with histologically proven (N)SCLC (all histological subtypes), treated with concurrent chemo- and radiotherapy.
- Ability to understand the protocol and willing to provide written informed consent
Exclusion Criteria:
- Concurrent participation in a clinical trial in which the subject is taking or receiving any investigational agent that may affect the frequency, severity or duration of mucositis.
- Pre-existent esophagitis.
- Receiving investigational treatment for the prevention or treatment of mucositis.
- Prior irradiation to the lung or head and neck region.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: No intervention
|
|
Active Comparator: Caphosol
|
Caphosol 4 times a day
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
number of patients with esophagitis
Time Frame: 3 months after the end of the Caphosolintervention
|
3 months after the end of the Caphosolintervention
|
duration until onset of esophagitis (days)
Time Frame: 3 months after the end of the Caphosolintervention
|
3 months after the end of the Caphosolintervention
|
duration of the period of esophagitis (days)
Time Frame: 3 months after the end of the Caphosolintervention
|
3 months after the end of the Caphosolintervention
|
severity of esophagitis (NCI Common Terminology Criteria for Adverse Events (CTCAE) 4.0 score)
Time Frame: 3 months after the end of the Caphosolintervention
|
3 months after the end of the Caphosolintervention
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of patients who discontinue chemotherapy due to esophagitis.
Time Frame: 3 months after Caphosolintervention
|
3 months after Caphosolintervention
|
Number of patients with delayed chemotherapy due to esophagitis.
Time Frame: 3 months after Caphosolintervention
|
3 months after Caphosolintervention
|
QoL (EORTC Quality of Life Questionnaire (QLQ) QLQ-C30 and EORTC QLQ-OES18)
Time Frame: 3 months after Caphosolintervention
|
3 months after Caphosolintervention
|
dysphagia(NCI CTCAE 4.0 score)
Time Frame: 3 months after Caphosolintervention
|
3 months after Caphosolintervention
|
analgetic use(NCI CTCAE 4.0 score)
Time Frame: 3 months after Caphosolintervention
|
3 months after Caphosolintervention
|
oral intake (NCI CTCAE 4.0 score)
Time Frame: 3 months after Caphosolintervention
|
3 months after Caphosolintervention
|
weight loss (NCI CTCAE 4.0 score)
Time Frame: 3 months after Caphosolintervention
|
3 months after Caphosolintervention
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Gastrointestinal Diseases
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Gastroenteritis
- Esophageal Diseases
- Lung Neoplasms
- Small Cell Lung Carcinoma
- Esophagitis
Other Study ID Numbers
- NL41938.015.12
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Small Cell Lung Cancer
-
University of Wisconsin, MadisonNational Cancer Institute (NCI)CompletedStage IIIA Non-small Cell Lung Cancer | Stage IIIB Non-small Cell Lung Cancer | Extensive Stage Small Cell Lung Cancer | Recurrent Small Cell Lung Cancer | Recurrent Non-small Cell Lung Cancer | Stage IV Non-small Cell Lung Cancer | Healthy, no Evidence of Disease | Limited Stage Small Cell Lung... and other conditionsUnited States
-
AIO-Studien-gGmbHBristol-Myers Squibb; Eli Lilly and Company; Merck Sharp & Dohme LLC; Pfizer; Gilead... and other collaboratorsRecruitingSmall-cell Lung Cancer | Non-small Cell Lung Cancer Metastatic | Non-small Cell Lung Cancer Stage I | Metastatic Non-small Cell Lung Cancer (NSCLC) | Non Small Cell Lung Cancer Stage III | Non-small Cell Lung Cancer Stage IIGermany
-
WindMIL TherapeuticsBristol-Myers SquibbTerminatedNSCLC | Lung Cancer | Lung Cancer Metastatic | Lung Cancer, Non-small Cell | Non Small Cell Lung Cancer | Non-small Cell Lung Cancer | Non-small Cell Lung Cancer Metastatic | Non Small Cell Lung Cancer MetastaticUnited States
-
University of California, San FranciscoAstraZenecaActive, not recruitingStage IIIA Non-Small Cell Lung Cancer | Stage I Non-Small Cell Lung Cancer | Stage IA Non-Small Cell Lung Cancer | Stage IB Non-Small Cell Lung Cancer | Stage II Non-Small Cell Lung Cancer | Stage IIA Non-Small Cell Lung Cancer | Stage IIB Non-Small Cell Lung CancerUnited States
-
National Cancer Institute (NCI)CompletedStage IIIA Non-small Cell Lung Cancer | Stage IIIB Non-small Cell Lung Cancer | Extensive Stage Small Cell Lung Cancer | Recurrent Small Cell Lung Cancer | Recurrent Non-small Cell Lung Cancer | Stage IV Non-small Cell Lung CancerUnited States
-
Wake Forest University Health SciencesNational Cancer Institute (NCI)CompletedTobacco Use Disorder | Stage IIIA Non-small Cell Lung Cancer | Stage IIIB Non-small Cell Lung Cancer | Recurrent Small Cell Lung Cancer | Limited Stage Small Cell Lung Cancer | Stage IA Non-small Cell Lung Cancer | Stage IB Non-small Cell Lung Cancer | Stage IIA Non-small Cell Lung Cancer | Stage IIB...United States
-
Washington University School of MedicineMerck Sharp & Dohme LLCWithdrawnNSCLC | Non Small Cell Lung Cancer | Non-small Cell Lung Cancer | Small Cell Lung Extensive Stage
-
Shanghai Chest HospitalRecruitingSmall Cell Lung Carcinoma | Small-cell Lung Cancer | Small Cell Lung Cancer Limited Stage | Small Cell Lung Cancer Extensive Stage | Small Cell Lung Cancer, Combined TypeChina
-
Alexander ChiNot yet recruitingNon-small Cell Lung Cancer Stage III | Non-small Cell Lung Cancer | Non-small Cell Lung Cancer Stage I | Non-small Cell Carcinoma | Non-small Cell Lung Cancer Stage IIChina
-
National Cancer Institute (NCI)Not yet recruitingStage IIIA Non-small Cell Lung Cancer | Stage IA Non-small Cell Lung Cancer | Stage IB Non-small Cell Lung Cancer | Stage IIA Non-small Cell Lung Cancer | Stage IIB Non-small Cell Lung CancerCanada
Clinical Trials on Caphosol
-
New York Head & Neck InstituteCompleted
-
University of ZurichCompletedAllogeneic Stem Cell TransplantationSwitzerland
-
Nantes University HospitalJazz PharmaceuticalsCompletedHematologic DiseaseFrance
-
Tampere University HospitalTurku University Hospital; Kuopio University HospitalCompleted
-
Impaqtt FoundationMemorial Sloan Kettering Cancer Center; Novartis; Pfizer; Leiden University Medical... and other collaboratorsCompletedRenal Cell Carcinoma | Hepatocellular Carcinoma | Gastrointestinal Stromal Tumors | Oral ComplaintsNetherlands
-
Jazz PharmaceuticalsUnknownOral MucositisUnited States
-
Medical College of WisconsinTerminatedOral MucositisUnited States
-
M.D. Anderson Cancer CenterCompleted
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedUnspecified Childhood Solid Tumor, Protocol Specific | Chronic Myelomonocytic Leukemia | Juvenile Myelomonocytic Leukemia | Secondary Acute Myeloid Leukemia | Childhood Acute Myeloid Leukemia in Remission | Mucositis | Childhood Acute Lymphoblastic Leukemia in Remission | Childhood Chronic Myelogenous... and other conditionsUnited States, Canada, Australia
-
The University of Texas Health Science Center at...South Texas Veterans Health Care SystemCompleted