KCT0005654
Not yet recruiting
未知
Efficacy and safety of Combined Therapeutics(Electroacupuncture and Musical Therapy) for Chemotherapy Induced Peripheral Neuropathy : A Randomized, Assessor-blinded, Controlled, Pilot Trial protocol
Kyung Hee University Oriental Medical Center0 sites46 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Kyung Hee University Oriental Medical Center
- Enrollment
- 46
- Status
- Not yet recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\[Inclusion criteria]
- •: must include all of the following conditions
- •1\) Over 19 years old, male and female
- •2\) Diagnosed with solid cancer(Stage 1 to 3\)
- •3\) Those who have completed chemotherapy\* as from the date of visit to screening
- •\* Platinum\-based or taxane\-based drug or their combined chemotherapy
- •4\) Diagnosed with CIPN
- •5\) A person with pain score of 4 or more due to CIPN measured by the Average Score of BPI\-SF(Breef Pain Index\-Short Form).
- •6\) A person whose ECOG(the Eastern Cooperative Oncology Group) performance status is 0 or 1\.
- •7\) A person whose life expectancy is more than six months.
Exclusion Criteria
- •\[Exclusion criteria]
- •: must exclude all of the following conditions
- •1\) A person who has peripheral neuropathic pain due to other causes other than CIPN (Diabetic peripheral neuropathy, Post\-herpetic neuralgia, Complex regional pain syndrome, HIV related neuropathy or Post\-traumatic/Post\-operative peripheral neuropathy, etc.).
- •2\) A person who has more severe side effects than pain after chemotherapy is completed (Tissue necrosis, Gastrointestinal toxicity, Nephrotoxicity, cardiotoxicity, etc.).
- •3\) A person with central neuropathic pain (spinal cord injury, Central post\-stroke pain, Neuropathic pain or Multiple sclerosis, etc.)
- •4\) A person with infection, severe heart failure or severe pulmonary as from the date of visit to screening
- •5\) A pregnant woman and breast\-feeding woman
- •6\) Those who are taking prohibited drugs or who need prohibited drugs during clinical trials as from the date of visit to screening (Refer to \#7\.(2\) Prohibit from doing together), Only the following can be enrolled.
- •\* A drug being taken for the treatment of CIPN such as Tricyclic antidepressants (Ex.Gabapentin), Pregabalin, etx.
- •\- A person who can maintain stable condition without changing the class, dose, usage of drugs during clinical trials 4 weeks before the date of visit to screening visit.
Outcomes
Primary Outcomes
Not specified
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