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Trial record 8 of 130 for:    complementary and alternative medicine AND quality

Impact on Quality of Life by Moxibustion in Chemotherapy for Cancer

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ClinicalTrials.gov Identifier: NCT02261571
Recruitment Status : Unknown
Verified October 2014 by Hyun jung, Jung, The Comprehensive and Integrative Medicine Institute of South Korea.
Recruitment status was:  Not yet recruiting
First Posted : October 10, 2014
Last Update Posted : October 10, 2014
Sponsor:
Information provided by (Responsible Party):
Hyun jung, Jung, The Comprehensive and Integrative Medicine Institute of South Korea

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Cancer Other: Moxibustion Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: A Pilot Study to Estimate the Efficacy of Moxibustion Stimulation at Abdominal Acupoints on Quality of Life in Cancer Patients Under Chemotherapy
Study Start Date : October 2014
Estimated Primary Completion Date : September 2015
Estimated Study Completion Date : September 2015

Arm Intervention/treatment
Experimental: Moxibustion
A series of moxibustion sessions within six weeks from baseline with adjuvant chemotherapy.
Other: Moxibustion

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



Primary Outcome Measures :
  1. functional Assessment of Cancer Therapy: General (FACT-G) [ Time Frame: change from baseline to 6 weeks ]

Secondary Outcome Measures :
  1. Body mass index [ Time Frame: change from baseline to 6 weeks ]
  2. immune function [ Time Frame: change from baseline to 6 weeks ]
    lymphocyte panel(CD3,4,8,19,26), WBC, Differential count

  3. M.D, Anderson symptom Inventory (MDASI) [ Time Frame: change from baseline to 6 weeks ]


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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02261571


Contacts
Contact: Hyun Jung Jung, KMD, Ph. D +82537702082 koreancarmen@gmail.com

Locations
Korea, Republic of
Deagu Hanny University Medical center Not yet recruiting
Deagu, Korea, Republic of, 704-123
Contact: Hyun Jung Jung, KMD, Ph. D         
Sub-Investigator: Kyung Soon Kim, KMD         
Sponsors and Collaborators
The Comprehensive and Integrative Medicine Institute of South Korea