Caphosol in Oral Mucositis Due to Targeted Therapy
キーワード
概要
説明
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.
日付
| 最終確認済み: | 10/31/2017 |
| 最初に提出された: | 12/20/2010 |
| 提出された推定登録数: | 12/20/2010 |
| 最初の投稿: | 12/22/2010 |
| 最終更新が送信されました: | 11/07/2017 |
| 最終更新日: | 11/12/2017 |
| 実際の研究開始日: | 10/31/2011 |
| 一次完了予定日: | 07/31/2015 |
| 研究完了予定日: | 09/30/2015 |
状態または病気
介入/治療
Other: supersaturated calcium-phosphate
Other: sodium chloride 0.9 %
段階
アームグループ
| 腕 | 介入/治療 |
|---|---|
| Other: sodium chloride -> supersaturated calcium-phosphate Patients in this arm start first with sodium chloride 0.9% mouth rinses and go crossover to supersaturated calcium-phosphate mouth rinses. | |
| Other: supersaturated calcium-phosphate -> sodium chloride Patients in this arm start first with supersaturated calcium-phosphate mouth rinses and go crossover to sodium chloride 0.9% mouth rinses. |
適格基準
| 研究の対象となる年齢 | 18 Years に 18 Years |
| 研究に適格な性別 | All |
| 健康なボランティアを受け入れる | はい |
| 基準 | 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 |
結果
主な結果の測定
1. Assess the severity of patient-reported oral adverse events as determined by the change in the Modified-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% [2 times 14 days]
二次的な結果の測定
1. Determine the decrease in grade of oral adverse events as measured by the NCI-CTCAE v4.0 once a week, during a 2 week treatment with Caphosol oral rinse versus NaCl 0.9% oral rinse, 4 times daily, 2 minutes with 30 ml solution [2 times 14 days]
2. Assess the incidence of dose delay or dose interruption, dose reduction and discontinue treatment owing to oral burden due to targeted anticancer therapy during the active oral rinse period, once a week [2 times 14 days]
3. To correlate the incidence of oral mucositis with: grade ≥ 2 hand-foot skin reaction (HFSR), and grade ≥ 2 papulopustular eruption (PPE) with all agents as measured by the NCI-CTCAE v4.0, during the active oral rinse period, once a week [2 times 14 days]
4. Side Study: Explorative analysis of polymorphism in genes encoding for pharmacokinetic and pharmacodynamic variables related to the pharmacodynamics of the TKIs [once]
