- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02261571
Impact on Quality of Life by Moxibustion in Chemotherapy for Cancer
A Pilot Study to Estimate the Efficacy of Moxibustion Stimulation at Abdominal Acupoints on Quality of Life in Cancer Patients Under Chemotherapy
Most cancer patients experience multiple symptoms related to chemotherapy and use CAM (complementary and alternative medicine) as an adjunct to conventional treatment. Moxibustion is traditional Korean medical therapeutic method and uses the heat generated by burning herbal preparations containing Artemisia vulgaris to stimulated acupoint.
Herein, the investigators propose an open-label pilot study investigating the effectiveness of moxibustion stimulation at abdominal acupoint on quality of life in cancer patients under chemotherapy.
Study Overview
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Hyun Jung Jung, KMD, Ph. D
- Phone Number: +82537702082
- Email: koreancarmen@gmail.com
Study Locations
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-
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Deagu, Korea, Republic of, 704-123
- Deagu Hanny University Medical center
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Contact:
- Hyun Jung Jung, KMD, Ph. D
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Sub-Investigator:
- Kyung Soon Kim, KMD
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Diagnostic histopathology of cancer
- Performance status of 0-2 on the European Cooperative Oncology Group (ECOG) performance scale.
- Patients on chemotherapy currently have plan to receive chemotherapy for more than 6 weeks.
- Follow-up possible during the clinical trial
- Informed signed consent
Exclusion Criteria:
- Patients with Severe Heart disease and hypertension that is not controlled (systolic blood pressure >160 or Diastolic blood pressure >100)
- Patients with diabetes that is not controlled (FBST >180 or BST>250)
- Patients with abdominal injury or severe ascites can't be received moxibustion therapy on abdomen.
- Hypersensitive section to moxibustion treatment
- Inability to comprehend or express oneself in the Korean language
- An Individual deemed to be ineligible by a physician
- Refusal to participate in this trial or to provide informed consent.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Moxibustion
A series of moxibustion sessions within six weeks from baseline with adjuvant chemotherapy.
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In the moxibustion treatment group, 3 moxibustion, 3 acupoints(CV12, CV8, CV54) will be heated with indirected moxibustion. The moxibustion will be removed when the patient feel hotness and require remove them |
No Intervention: Waiting
Participants who will be allocated to waitlist will receive no moxibustion treatments throughout the 6 weeks while receiving adjuvant chemotherapy
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
functional Assessment of Cancer Therapy: General (FACT-G)
Time Frame: change from baseline to 6 weeks
|
change from baseline to 6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Body mass index
Time Frame: change from baseline to 6 weeks
|
change from baseline to 6 weeks
|
|
immune function
Time Frame: change from baseline to 6 weeks
|
lymphocyte panel(CD3,4,8,19,26), WBC, Differential count
|
change from baseline to 6 weeks
|
M.D, Anderson symptom Inventory (MDASI)
Time Frame: change from baseline to 6 weeks
|
change from baseline to 6 weeks
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Lee MS, Kang JW, Ernst E. Does moxibustion work? An overview of systematic reviews. BMC Res Notes. 2010 Nov 5;3:284. doi: 10.1186/1756-0500-3-284.
- Lee MS, Choi TY, Park JE, Lee SS, Ernst E. Moxibustion for cancer care: a systematic review and meta-analysis. BMC Cancer. 2010 Apr 7;10:130. doi: 10.1186/1471-2407-10-130.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CIMI-14-01-08
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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