Status Approved
First Submitted Date
2013/08/10
Registered Date
2013/12/05
Last Updated Date
2015/06/09
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
| CRIS Registration Number |
KCT0000949 |
|---|---|
| Unique Protocol ID | CIMI-13-01-08 |
| Public/Brief Title | Effect of Acupuncture for Radioactive-Iodine Induced Anorexia in Thyroid Cancer Patients |
| Scientific Title | Effect of Acupuncture for Radioactive-Iodine Induced Anorexia in Thyroid Cancer Patients : A Randomized Double Blinded Sham Controlled Pilot Study |
| Acronym | |
| MFDS Regulated Study | No |
| IND/IDE Protocol | No |
| Registered at Other Registry | No |
| Healthcare Benefit Approval Status |
2. Institutional Review Board / Ethics Committee
| Board Approval Status | Submitted approval |
|---|---|
| Board Approval Number | 13-01 |
| Approval Date | 2013-08-09 |
| Institutional Review Board Name | Institutional Review Board Dunsan Oriental Hospital of Daejeon University |
| Institutional Review Board Address | |
| Institutional Review Board Telephone | |
| Data Monitoring Committee | No |
3. Contact Details
| Contact Person for Principal Investigator / Scientific Queries | |
|---|---|
| Name | Hwa-seung Yoo |
| Title | associate professor |
| Telephone | +82-42-470-9132 |
| Affiliation | Dunsan Korean Medicine Hospital of Daejeon University |
| Address | |
| Contact Person for Public Queries | |
| Name | Ju-hyun Jeon |
| Title | |
| Telephone | +82-42-470-9140 |
| Affiliation | Daejeon Korean Medicine Hospital of Daejeon University |
| Address | |
| Contact Person for Updating Information | |
| Name | Ju-hyun Jeon |
| Title | |
| Telephone | +82-42-470-9140 |
| Affiliation | Daejeon Korean Medicine Hospital of Daejeon University |
| Address | |
4. Status
| Study Site | Single | |
|---|---|---|
| Overall Recruitment Status | Completed | |
| Date of First Enrollment | 2013-08-27 Actual | |
| Target Number of Participant | 20 | |
| Primary Completion Date | 2014-02-19 , Actual | |
| Study Completion Date | 2014-02-21 , Actual | |
| Recruitment Status by Participating Study Site 1 | ||
| Name of Study | Daejeon Korean Medicine Hospital of Daejeon University | |
| Recruitment Status | Completed | |
| Date of First Enrollment | 2013-08-27 , | |
5. Source of Monetary / Material Support
| 1. Source of Monetary/Material Support | |
|---|---|
| Organization Name | Ministry of Health & Welfare |
| Organization Type | Government |
| Project ID | CIMI-13-01-08 |
6. Sponsor Organization
| 1. Sponsor Organization | |
|---|---|
| Organization Name | Daejeon Korean Medicine Hospital of Daejeon University |
| Organization Type | Medical Institute |
7. Study Summary
| Lay Summary | The aim of this study is to evaluate the effect and safety of acupuncture treatment for Radioactive-Iodine Induced Anorexia in Thyroid Cancer Patients. Participants are treated with active or sham acupuncture three times per week for 2 weeks. FAACT scale score, VAS, Weight, BMI, ACTH, Cortisol are compared before and after treatment. |
|---|
8. Study Design
| Study Type | Interventional Study |
|---|---|
| Study Purpose | Treatment |
| Phase | Not applicable |
| Intervention Model | Parallel |
| Blinding/Masking | Double |
| Blinded Subject | Subject, Investigator |
| Allocation | RCT |
| Intervention Type | Medical Device |
| Intervention Description | The aim of this study is to evaluate the effect and safety of acupuncture treatment for Radioactive-Iodine Induced Anorexia in Thyroid Cancer Patients. Participants are treated with active or sham acupuncture three times per week for 2 weeks. FAACT scale score, VAS, Weight, BMI, ACTH, Cortisol are compared before and after treatment. |
| Number of Arms | 2 |
| Arm 1 |
Arm Label Active Acupuncture Treatment |
|
Target Number of Participant 10 |
|
|
Arm Type Experimental |
|
|
Arm Description active acupuncture treatment three times per week for 2 weeks |
|
| Arm 2 |
Arm Label Sham Acupuncture Treatment |
|
Target Number of Participant 10 |
|
|
Arm Type Sham comparator |
|
|
Arm Description sham acupuncture treatment three times per week for 2 weeks |
9. Subject Eligibility
| Condition(s)/Problem(s) |
* (C00-D48)Neoplasms (C73)Malignant neoplasm of thyroid gland |
|---|---|
| Rare Disease | No |
| Inclusion Criteria |
Gender Both |
|
Age 20Year~65Year |
|
|
Description 1) Among the thyroid cancer patients suffering from the Radioactive-Iodine Induced Anorexia, people who got the therapy before 14 to 60 days, and complain of more than 4 points when we evaluate the grade of anorexia using Visual Analogue Scale(VAS) 2) People who are literate, 20-65 year old 3) People who volunteered to participate in this clinical study and signed the informed consent |
|
| Exclusion Criteria |
1) People who have impossible oral intake 2) People who are diagnosed and being treated with mental disease such as Dementia, Delirium, Depression, etc 3) People who complain of more than 7 points when we use Numeric Rating Scale, which can affect appetite or calorie intake, within 2 weeks of Clinical study screening 4) People who have diseases which can influence on appetite (such as hypoadrenalism, etc) 5) People who are receiving appetizers (such as megestrol acetate, corticosteroids, thalidomide) 6) Women who have the possibility of pregnancy 7) People who are beyond the Eastern Cooperative Oncology Group(ECOG) 2 8) Others who are judged to be difficult to perform the clinical study |
| Healthy Volunteers |
10. Outcome Measure(s)
| Type of Primary Outcome | /Safety/Efficacy | |
|---|---|---|
| Primary Outcome(s) 1 | ||
| Outcome | Anorexia Cachexia Subscale (ACS) score change among FAACT scale |
|
| Timepoint | pretreatment, after 2 weeks(after final 6th acupuncture treatment ) |
|
| Secondary Outcome(s) 1 | ||
| Outcome | Anorexia Cachexia Subscale (ACS) score change among FAACT scale |
|
| Timepoint | after 1 week, after 4weeks |
|
| Secondary Outcome(s) 2 | ||
| Outcome | other item score changes besides Anorexia Cachexia Subscale (ACS) among FAACT scale |
|
| Timepoint | pretreatment, after 1 week, after 2 weeks(after final 6th acupuncture treatment ), after 4weeks |
|
| Secondary Outcome(s) 3 | ||
| Outcome | Anorexia VAS score change |
|
| Timepoint | pretreatment, after 1 week, after 2 weeks(after final 6th acupuncture treatment ), after 4weeks |
|
| Secondary Outcome(s) 4 | ||
| Outcome | Weight change |
|
| Timepoint | pretreatment, after 1 week, after 2 weeks(after final 6th acupuncture treatment ), after 4weeks |
|
| Secondary Outcome(s) 5 | ||
| Outcome | BMI change |
|
| Timepoint | pretreatment, after 1 week, after 2 weeks(after final 6th acupuncture treatment ), after 4weeks |
|
| Secondary Outcome(s) 6 | ||
| Outcome | ACTH, Cortisol numerical value change |
|
| Timepoint | pretreatment, after 2 weeks(after final 6th acupuncture treatment ) |
|
11. Study Results and Publication
| Result Registered | Yes |
|---|---|
| Final Enrollment Number | |
| Number of Publication | 1 |
| Publications 1 |
Jeon JH, Yoon J, Cho CK, Jung IC, Kim S, Lee SH, Yoo HS.. Effect of acupuncture for radioactive-iodine-induced anorexia in thyroid cancer patients: a randomized, double-blinded, sham-controlled pilot study.. Integr Cancer Ther. SCI. 2015-05-01 , VOL : 14(3) page : 221 ~ 230 |
| Results Upload | |
| Date of Posting Results | 2013/12/05 |
| Protocol URL or File Upload | |
| Brief Summary |
12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
| Sharing Statement | Not provided at time of Registration |
|---|
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