Cancer Clinical Trial
Official title:
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.
| Status | Not yet recruiting |
| Enrollment | 20 |
| Est. completion date | September 2015 |
| Est. primary completion date | September 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 20 Years to 70 Years |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Deagu Hanny University Medical center | Deagu |
| Lead Sponsor | Collaborator |
|---|---|
| The Comprehensive and Integrative Medicine Institute of South Korea |
Korea, Republic of,
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. Review. — View Citation
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | functional Assessment of Cancer Therapy: General (FACT-G) | change from baseline to 6 weeks | No | |
| Secondary | Body mass index | change from baseline to 6 weeks | No | |
| Secondary | immune function | lymphocyte panel(CD3,4,8,19,26), WBC, Differential count | change from baseline to 6 weeks | No |
| Secondary | M.D, Anderson symptom Inventory (MDASI) | change from baseline to 6 weeks | No |
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