Conditions: Radiotherapy-induced Nausea and Vomiting (RINV)
Allocation:  | Intervention model: PARALLEL
Enrollment: 189
Healthy volunteers: no

Brief 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.

Detailed description:
Exploratory study of dose response of SyB D-0701 to preventing effects for nausea and emesis associated with radiotherapy (fractionated/localized irradiation)

Arms:
arm 1: None arm 2: None arm 3: None

Interventions: intervention 1: SyB D-0701 intervention 2: Placebo
Intervention descriptions: intervention 1: 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. intervention 2: 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.

Protocol document: