Bone Marrow Diseases, Mucositis, Nasopharyngeal Neoplasms, Salivary Gland Diseases
Conditions
Keywords
Nasopharyngeal carcinoma, Amifostine, Myelosuppression, Xerostomia, Mucositis
Brief summary
RATIONALE * Radiotherapy is the primary therapeutic strategy for nasopharyngeal carcinoma. * Radiotherapy may cause adverse effect such as xerostomia and mucositis. * Amifostine has the ability of protecting the normal tissue but also has some side effects. PURPOSE * This phase II trial is to study the protecting effect and safety of different Amifostine regimens in patients with nasopharyngeal carcinoma.
Detailed description
RATIONALE: Nasopharyngeal carcinoma is a kind of malignant tumor which is treated primarily by radiation therapy. This therapeutic strategy often causes adverse effects such as dysfunction of salivary gland and lesion of oral mucosa. With concurrent chemotherapy, it may also cause toxicity to kidney, bone marrow, and other organs or tissues. When administered prior to chemoradiotherapy, Amifostine has been proved to has the ability of protecting the normal from these adverse effects so as to improve the patient tolerance. However, there are also some side effects of Amifostine itself, such as nausea, vomiting and hypotension, especially when high dose is applied. PURPOSE: This phase II randomized controlled trial is to study the protecting effect and its safety of Amifostine every-other-day regimen compared with standard everyday regimen on adverse effects such as myelosuppression, xerostomia and mucositis, in patients with nasopharyngeal carcinoma Stage T1-T4, N0-N3, M0 and undergoing concurrent chemoradiotherapy.
Interventions
DRUGAmifostine every-other-day regimen
Amifostine 400mg/d, every-other-day regimen from Monday to Friday, every week repetition during radiotherapy
DRUGAmifostine everyday regimen
Amifostine 400mg/d, everyday regimen from Monday to Friday, every week repetition during radiotherapy
Sponsors
Dalian Merro Pharmaceutical Co. Ltd
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Nasopharyngeal cancer patients diagnosed by pathology or cytology * UICC/AJCC 2010 Stage T1-4 N0-3 M0 * Male or female patients with age between 18 and 75 years old * Karnofsky Performance Scores ≥ 60 * Expected survival ≥ 3 months * Without dysfunction of heart, lung, liver, kidney and hematopoiesis * No previous allergic reaction to the drug
Exclusion criteria
* History of alcohol or drug abuse within 3 months * Pregnant or lactating women * Currently under treatment with other similar drugs * Anti-hypertension drugs applied in less than 24 hours * Severe hypocalcemia * Dysfunction of heart, lung, liver, kidney or hematopoiesis * Severe neurological, mental or endocrine diseases * Previous allergic reaction to the drug * Patients participated in clinical trials of other drugs within last 3 months * Other unsuitable reason
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect on improving myelosuppression | One week before radiotherapy; Once a week during radiotherapy, up to 7 weeks; Three months after radiotherapy | Severity of myelosuppression is evaluated on basis of Common Terminology Criteria for Adverse Events (CTCAE) 4.0 criteria. |
| Effect on improving xerostomia | One week before radiotherapy; Once a week during radiotherapy, up to 7 weeks; Three months after radiotherapy | Severity of xerostomia is evaluated on basis of CTCAE 4.0 criteria. |
| Effect on improving mucositis | One week before radiotherapy; Once a week during radiotherapy, up to 7 weeks; Three months after radiotherapy | Severity of mucositis is evaluated on basis of CTCAE 4.0 criteria. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effect on improving Karnofsky Performance Scores (KPS) | One week before radiotherapy; Once a week during radiotherapy, up to 7 weeks; Three months after radiotherapy | — |
| Incidence and severity of Vomiting | One week before radiotherapy; Once a week during radiotherapy, up to 7 weeks; Three months after radiotherapy | One of the adverse effects of Amifostine. |
| Incidence and severity of Hypocalcemia | One week before radiotherapy; Once a week during radiotherapy, up to 7 weeks; Three months after radiotherapy | One of the adverse effects of Amifostine. |
| Incidence and severity of Nausea | One week before radiotherapy; Once a week during radiotherapy, up to 7 weeks; Three months after radiotherapy | One of the adverse effects of Amifostine. |
| Incidence and severity of Hypotension | One week before radiotherapy; Once a week during radiotherapy, up to 7 weeks; Three months after radiotherapy | One of the adverse effects of Amifostine. |
| Effect on improving Quality of Life (QOL). | One week before radiotherapy; Once a week during radiotherapy, up to 7 weeks; Three months after radiotherapy | — |
Countries
China
Contacts
Primary ContactYun-fei Xia, Prof.
Backup ContactHui Chang, M.D.
Outcome results
None listed