Impact on Quality of Life by Moxibustion in Chemotherapy for Cancer

Study Overview
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Brief Summary
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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.

Official Title
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A Pilot Study to Estimate the Efficacy of Moxibustion Stimulation at Abdominal Acupoints on Quality of Life in Cancer Patients Under Chemotherapy

Conditions
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Cancer

Intervention / Treatment
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* Other: Moxibustion


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Moxibustion<br>A series of moxibustion sessions within six weeks from baseline with adjuvant chemotherapy. | Other: Moxibustion<br>* 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<br>|
| No Intervention: Waiting<br>Participants who will be allocated to waitlist will receive no moxibustion treatments throughout the 6 weeks while receiving adjuvant chemotherapy | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| functional Assessment of Cancer Therapy: General (FACT-G) |  | change from baseline to 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body mass index |  | change from baseline to 6 weeks | 
| immune function | lymphocyte panel(CD3,4,8,19,26), WBC, Differential count | change from baseline to 6 weeks | 
| M.D, Anderson symptom Inventory (MDASI) |  | change from baseline to 6 weeks |