Phase III Randomized Double-blind Cross-over Trial of Caphosol® Versus NaCl 0.9% in the Relief of Oral Mucositis in Renal Cell Carcinoma, Hepatocellular Carcinoma, and Gastrointestinal Stromal Tumor Patients Receiving Targeted Therapy
18 Years
N/A
Both
Oral Mucositis, Renal Cell Carcinoma, Hepatocellular Carcinoma, Gastrointestinal Stromal Tumors
Trial Information
Phase III Randomized Double-blind Cross-over Trial of Caphosol® Versus NaCl 0.9% in the Relief of Oral Mucositis in Renal Cell Carcinoma, Hepatocellular Carcinoma, and Gastrointestinal Stromal Tumor Patients Receiving Targeted Therapy
OM with mucosal change, associated pain, and taste change - are clinically relevant
toxicities of TKI's and mTORI's presently in use. The incidence of oral mucositis of any
grade is for sunitinib 38%, sorafenib 28%, pazopanib 4%, temsirolimus 41%, and for
everolimus 44%.
Optimal antitumor activity requires maintaining the highest tolerable dose in individual
patients. In order to improve health related quality of life (HRQoL) and patient adherence,
adverse effects should be prevented, if possible avoided and treated if necessary. Current
oral formulations consist of various schedules (continuous administration or 4 weeks on, 2
weeks off) to optimize the benefit-risk profile. Adherence to anti-cancer treatment is
particularly important when prescribing oral therapies as adherence to the protocol can have
a significant impact on efficacy and the severity of treatment-related AEs. As sorafenib,
sunitinib, pazopanib, and everolimus are taken in the outpatient setting, patient education
on the correct treatment dosing, usage and the nature, recognition, and severity of AEs is
essential.
Recent data suggest that TKI and mTORI associated OM is different from conventional
chemotherapy related OM. Oral ulceration usually presents as aphthous-like ulcerations and
has in some studies been reported as mucositis. An analysis of the appearance, course, and
toxicity experiences demonstrated that the condition is distinct from conventional mucositis
and more closely resembles aphthous oral mucositis. These TKI/mTORI related ulcers may
represent a dose-limiting toxicity for this new class of agents, especially considering the
fact that even lower grade mucositis with chronic daily dosing may be cumbersome to the
patient and lead to dose reductions. Studies of treatment strategies for aphthous OM may
therefore be important for the dose adherence of TKI and mTORI and for the overall
acceptance of this therapy for patients.
Inclusion Criteria:
- Male and female subjects
- ≥18 years of age
- Histological proof of RCC, HCC or GIST
- Oral adverse events > grade 0 due to sunitinib, sorafenib, pazopanib, temsirolimus,
or everolimus in mono therapy at study entry
- Written informed consent
- Eastern Co-operative Oncology Group (ECOG) performance status ≤ 2
- Able to perform oral rinsing
- Able to complete questionnaires by themselves or with assistance
Exclusion Criteria:
- Any previous systemic antineoplastic treatment within 4 weeks of initiation of
current targeted anticancer therapy
- Current antineoplastic combination cytotoxic chemotherapy therapy
- Physiologic condition that precludes the use of an oral rinse
- Hypersensitivity to Caphosol ingredients
- Use of palifermin, oral cryotherapy, low level laser therapy, topical oral steroids
within 3 weeks of current targeted anticancer therapy
- Oral abnormalities defined as baseline oral assessment of NCI-CTCAE v4.0 grade > 0
- Current use of agents that are known to be strong inducers or inhibitors of CYP3A4
that can not be stopped
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Supportive Care
Outcome Measure:
Assess the severity of patient-reported oral adverse events as determined by the change in the VHNSS2.0 score 3 times a week, from onset of oral adverse events during the active oral rinse period with Caphosol versus NaCl 0.9%
Outcome Time Frame:
2 times 14 days
Safety Issue:
No
Principal Investigator
Christine B Boers-Doets, RN, MSc
Investigator Role:
Study Chair
Investigator Affiliation:
Waterland Hospital
Authority:
Netherlands: Medical Ethics Review Committee (METC)
Study ID:
Esperanz-002
NCT ID:
NCT01265810
Start Date:
September 2011
Completion Date:
April 2014
Related Keywords:
- Oral Mucositis
- Renal Cell Carcinoma
- Hepatocellular Carcinoma
- Gastrointestinal Stromal Tumors
- oral mucositis
- targeted therapy
- Caphosol
- management
- Carcinoma
- Carcinoma, Renal Cell
- Stomatitis
- Gastrointestinal Stromal Tumors
- Mucositis
- Carcinoma, Hepatocellular
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