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The Effect of Caphosol® on the Development of Esophagitis in Small Cell Lung Cancer (SCLC) Patients Treated With Concurrent Chemo/Radiotherapy (CARACTER)

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ClinicalTrials.gov Identifier: NCT01809756
Recruitment Status : Unknown
Verified March 2013 by drs. Nils E van 't Veer, ziekenhuisapotheker, Amphia Hospital.
Recruitment status was:  Not yet recruiting
First Posted : March 13, 2013
Last Update Posted : March 13, 2013
Sponsor:
Collaborator:
Erasmus Medical Center
Information provided by (Responsible Party):
drs. Nils E van 't Veer, ziekenhuisapotheker, Amphia Hospital

Brief Summary:

Rationale: In the Netherlands 1731 people are being diagnosed with SCLC (Small Cell Lung Cancer) in 2010. This is approximately 14% 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 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) 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 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 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 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 SCLC patients undergoing radiation therapy with chemotherapy who receive Caphosol®.

Secondary study parameters/outcome of the study (if applicable):

  1. To correlate components of esophagitis data with clinical outcomes (pain, dysphagia, analgetic use, oral intake, weight loss, infection, need for hospitalization, QoL)
  2. 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.


Condition or disease Intervention/treatment Phase
Small Cell Lung Cancer Other: Caphosol Not Applicable

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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Prevention
Official Title: The Effect of Caphosol® on the Development of Esophagitis in Small Cell Lung Cancer (SCLC)Patients Treated With Concurrent Chemo/Radiotherapy A Prospective Study of Caphosol + Standard of Care Versus Standard of Care
Estimated Primary Completion Date : April 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Active Comparator: Caphosol Other: Caphosol
Caphosol 4 times a day

No Intervention: No intervention



Primary Outcome Measures :
  1. number of patients with esophagitis [ Time Frame: 3 months after the end of the Caphosolintervention ]
  2. duration until onset of esophagitis (days) [ Time Frame: 3 months after the end of the Caphosolintervention ]
  3. duration of the period of esophagitis (days) [ Time Frame: 3 months after the end of the Caphosolintervention ]
  4. severity of esophagitis (NCI Common Terminology Criteria for Adverse Events (CTCAE) 4.0 score) [ Time Frame: 3 months after the end of the Caphosolintervention ]

Secondary Outcome Measures :
  1. Number of patients who discontinue chemotherapy due to esophagitis. [ Time Frame: 3 months after Caphosolintervention ]
  2. Number of patients with delayed chemotherapy due to esophagitis. [ Time Frame: 3 months after Caphosolintervention ]
  3. QoL (EORTC Quality of Life Questionnaire (QLQ) QLQ-C30 and EORTC QLQ-OES18) [ Time Frame: 3 months after Caphosolintervention ]
  4. dysphagia(NCI CTCAE 4.0 score) [ Time Frame: 3 months after Caphosolintervention ]
  5. analgetic use(NCI CTCAE 4.0 score) [ Time Frame: 3 months after Caphosolintervention ]
  6. oral intake (NCI CTCAE 4.0 score) [ Time Frame: 3 months after Caphosolintervention ]
  7. weight loss (NCI CTCAE 4.0 score) [ Time Frame: 3 months after Caphosolintervention ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years or older
  • Patients with histologically proven 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01809756


Contacts
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Contact: J.G.J.V. Aerts, MD, PhD 0031765951000 jaerts@amphia.nl

Locations
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Netherlands
Amphia Hospital Not yet recruiting
Breda, Noord-Brabant, Netherlands, 4818 CK
Contact: J.G.J.V. Aerts, MD, PhD    0031765951000    jaerts@amphia.nl   
Principal Investigator: Nils E. van 't Veer, drs.         
Sub-Investigator: Keetie van Loenhout         
Principal Investigator: Joachim Aerts, MD PhD         
Erasmus Medical Centre Not yet recruiting
Rotterdam, Netherlands, 3015AA
Contact: J.G.J.V. Aerts, MD, PhD    0031107040704    jaerts@amphia.nl   
Sponsors and Collaborators
Amphia Hospital
Erasmus Medical Center

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Responsible Party: drs. Nils E van 't Veer, ziekenhuisapotheker, drs. (ziekenhuisapotheker), Amphia Hospital
ClinicalTrials.gov Identifier: NCT01809756     History of Changes
Other Study ID Numbers: NL41938.015.12
First Posted: March 13, 2013    Key Record Dates
Last Update Posted: March 13, 2013
Last Verified: March 2013

Additional relevant MeSH terms:
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Lung Neoplasms
Small Cell Lung Carcinoma
Esophagitis
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis