Phase II Study of SyB D-0701 for Radiotherapy-Induced Nausea and Vomiting (RINV)
Condition: Radiotherapy-induced Nausea and Vomiting (RINV)
MeSH terms: Nausea; Vomiting
Intervention: SyB D-0701; Placebo
Intervention description: Study drug patches [Low dose group (18.75 mg): SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 patch, High dose group (30.00 mg): SyB D-0701 15 cm2 patch + SyB D-0701 25 cm2 patch] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.; Study drug patches (Placebo group: SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 placebo patch) assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
Phase: Phase 2
Study type: Interventional
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 189.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to explore the dose response of SyB D-0701 for preventing nausea
      and emesis associated with radiotherapy (fractionated/localized irradiation) in cancer
      patients scheduled to receive radiotherapy (fractionated/localized irradiation) alone.
    

Eligibility criteria:

        Inclusion Criteria Patients must satisfy the following conditions listed below.

          1. Patients with histologically verified malignant tumors

          2. Patients receiving radiotherapy alone who are scheduled for at least 3 fractions, each
             at a radiation dose of 1.5 to 3.0 Gy

          3. Cancer patients scheduled for radiotherapy over a field of at least 100 cm2 (50 cm2 or
             more in cases of irradiation of the vertebrae only) that includes the abdomen and
             pelvis (region with upper edge at the 11th thoracic vertebrae and lower edge at pelvic
             cavity)

          4. Patients not scheduled to receive anti-tumor agents between the first and the fifth
             day of radiotherapy. If the patient has a history of anti-tumor agent therapy,
             however, at the time of the patient's registration, at least 5 days must have elapsed
             since drug administration was terminated, and the patient must not be scheduled to
             receive any anti-tumor agent from the first to the fifth day of radiotherapy

          5. Male patients who are surgically sterilized, or who agree to practice adequate
             contraception during the study

          6. Female patients of child-bearing potential who agree to practice adequate
             contraception during the study

          7. Patients whose performance status (PS) of Eastern Cooperative Oncology Group (ECOG) is
             0 to 2

          8. Patients who were at least 20 years of age when their consent was obtained

          9. Patients who have given consent in writing to participate in the study with full
             understanding of the explanatory documents

        Exclusion Criteria Patients who satisfy any of the following conditions will not be
        enrolled in the study.

          1. Patients with nausea and/or emesis; patients who also have intestinal obstruction,
             vestibular dysfunction (e.g., epilepsy), Meniere's syndrome, cerebral metastasis,
             electrolyte imbalance (hypercalcemia, hyperglycemia, hyponatremia), uremia, etc., and
             patients for whom it is judged that there is a high probability that their nausea or
             emesis arises from the aforementioned causes. Registration is possible, however, for
             patients with motion sickness (vehicle sickness) or patients with temporary
             nausea/emesis arising from routine activities.

          2. Patients with primary or metastasized brain tumors who show signs of elevated
             intracranial pressure

          3. Patients who previously received radiotherapy to the brain or to the region that
             includes the abdomen and pelvis (region with upper edge at the 11th thoracic vertebrae
             and lower edge at pelvic cavity)

          4. Patients who take drugs that affect the evaluation of nausea or emesis (rescue
             medication and 5-hydroxytryptamine 3 (5-HT3) receptor antagonists, neurokinin 1 (NK1)
             receptor antagonists, anxiolytics, psychotropic drug, opioid analgesics and
             corticosteroid [systemic administration] except for rescue medication)

          5. Patients with abnormal findings (e.g., erythema, rash, wounds) at sites where the
             study drug has been applied

          6. Patients with a history of hypersensitivity to study drug ingredients or to other
             5-HT3 receptor antagonists

          7. Patients with a history of allergy involving dermal symptoms

          8. Patients with clear signs of infection (including viral infection)

          9. Patients with complications from drug or alcohol dependence, or with a history of the
             same

         10. Patients who have participated in some type of clinical study (including
             physician-initiated clinical studies or clinical research) within 3 months prior to
             their registration for the present study and who have been given a study drug
             (including drugs not yet approved). Patients can be registered for this study,
             however, if they have participated in a clinical study, etc., in which only drugs
             already approved have been used.

         11. Patients with serious hepatic or renal damage [Grade 3 or above in the Common
             Terminology Criteria for Adverse Events (CTCAE) (ver. 4.0-JCOG)]

         12. Patients with cardiac dysfunction

         13. Patients who are pregnant, who might be pregnant or who are currently lactating

         14. Other patients judged as unsuitable by the investigator or sub-investigators