Development of the hot compress to reduce vascular pain caused by peripheral intravenous oxaliplatin administration

JRCT ID: jRCT1040220143

Registered date:16/02/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Colorectal cancer,Small bowel cancer,Gastric cancer
• Date of first enrollment: 14/03/2023
• Target sample size: 120
• Study type: Interventional

Intervention(s)

The hot compress using this new method is administered at the start of L-OHP
NRS assessment will be performed on the patient every 20 minutes (+-5 minutes) after the start of L-OHP and a questionnaire will be performed at the end of L-OHP administration

Outcome(s)

• Primary Outcome: Efficacy of the hot compress

Secondary Outcome

1)NRS evaluation of vascular pain caused by L-OHP administration when using the new hot compress cover
2)QOL evaluation of the feeling of using the new hot compress cover
3)Number of times L-OHP was administered at the start of hot compress
4)Puncture side
5)Puncture site
6)Gauge of puncture needle used (either 22 gauge or 24 gauge)
7)Evaluation of peripheral sensory neuropathy (CTCAE v5.0)
8)Whether Aqua gel was added or not
9)Surface temperature of the skin above the IV site
10)Presence of low temperature burns (skin redness, blistering, pain)
11)Contact dermatitis (erythema, maculopapules, vesicles or more)
12)NRS evaluation at the onset of vascular pain, worst case of vascular pain, and completion of L-OHP administration, time to onset of vascular pain, puncture side and puncture site, gauge of the puncture needle, peripheral sensory neuropathy (CTCAE v5.0), when performing the existing method

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both

Include criteria

1)Patient with vascular pain after L-OHP administration via peripheral venous route, warm compress was performed using existing method, and L-OHP is scheduled to be administered next course
2)Eastern Cooperative Oncology Group Performance status 0 or 1
3)No dementia or psychiatric disorders that could affect the evaluation
4)Patients with vascular pain during L-OHP administration, with NRS evaluation and evaluation of warm compress care after performing existing methods
5)Written informed consent

Exclude criteria

1)Patients whose L-OHP dosage at the time of the existing method differs from the dosage of L-OHP at the time of the new method
2)Steroids are mixed in the L-OHP solution
3)Patients with vasculitis as a complication
4)Patients with significant peripheral venous channeling difficulties
5)Patients for whom the investigator determines that enrollment in the study is inappropriate

Related Information

• Primary Sponsor: Iwasaki Yuko