Efficacy and safety of Combined Therapeutics(Electroacupuncture and Musical Therapy) for Chemotherapy Induced Peripheral Neuropathy
- Conditions
- Diseases of the nervous system
- Registration Number
- KCT0005654
- Lead Sponsor
- Kyung Hee University Oriental Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 46
[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.
8) A person who voluntarily agrees to participate in this clinical trial
[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.
* Non-opioid analgesics and Corticosteroid
- A person who agrees to discontinue medication during a clinical trial and has a wash out period for two weeks before randomization
- A person who can maintain stable condition without changing the class, dose, usage of drugs during clinical trials 2 weeks before the date of visit to screening visit.
* Bisphosphonate
- A person who can maintain stable condition without changing the class, dose, usage of drugs during clinical trials 6 months before the date of visit to screening visit.
7) A person whose hematological findings correspond to the following conditions:
- AST, ALT > 3 times the upper limit of normal range
- Creatinine > 1.5 times the upper limit of normal range
- Bilirubin > 1.5 times the upper limit of normal range
- WBC < 3,000/mm3
- Platelet < 75,000/mm3
8) A person whose ability to read, understand, and write letters has been significantly reduced, making it difficult to assess his/her own pain.
9) A person who is scheduled to undergo operation or radiotherapy within 10 weeks of randomization.
10) A person who is scheduled for additional chemotherapy during this clinical trial period
11) A person who has participated in another clinical trial within 1 month of the beginning of this clinical trial or plans to participate in another clinical trial during this clinical trial.
12) Any other person decided inappropriate by clinical investigator to participate in this clinical trial
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method the Average score of BPI-SF
- Secondary Outcome Measures
Name Time Method the Average score of BPI-SF;the Severity score of BPI-SF;Variance of the EORTC QLQ-C30;Variance of the EORTC QLQ-CIPN20;The ratio of subjects to ECOG performance status change (maintained, improved or deteriorated);Adverse events;Laboratory test (General blood test, Blood chemistry, Urinalysis), Electrocardiography, Vital signs (Pulse, Blood pressure, Body temperature);Vital signs (Pulse, Blood pressure, Body temperature)