Transcutaneous carbon dioxide (CO2) application for malignant bone and soft tissue tumor (sarcoma)

JRCT ID: jRCTs052180038

Registered date:29/01/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Malignant bone and soft tissue tumor (Sarcoma)
• Date of first enrollment: 23/03/2018
• Target sample size: 10
• Study type: Interventional
• Intervention(s): Transcutaneous carbon dioxide (CO2) application: The area of skin around the tumor is treated with CO2 hydrogel. This area is then sealed with a polyethylene bag, and 100% CO2 gas is administered into the bag. The treatment is performed 20 min for each, 5 times a week (every weekday) for 2 weeks, total 10 times.

Outcome(s)

• Primary Outcome: complication

Secondary Outcome

antitumor effect
local blood flow

Key inclusion & exclusion criteria

• Age minimum: >= 16age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(1) Patients who have been histologically diagnosed as either malignant bone tumor or malignant soft tissue tumor
(2) Age 16 yo or more
(3) More than 4 weeks since any prior therapy
(4) PS 0-1
(5) The patient have consented to the study in the document

Exclude criteria

(1) Skin ulcer or pathological fracture in the treated area
(2) Peripheral arterial disease or ischemic disease in the affected limb
(3) Skin disease in the affected limb
(4) Active infectious disease in the affected limb
(5) Other medical or psychological unsuitable reasons

Related Information

• Primary Sponsor: Fukase Naomasa
• Secondary ID(s): UMIN000029101