Impact on Quality of Life by Moxibustion in Chemotherapy for Cancer

October 9, 2014 updated by: Hyun jung, Jung, The Comprehensive and Integrative Medicine Institute of South Korea

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

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Deagu, Korea, Republic of, 704-123
        • Deagu Hanny University Medical center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
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

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

This is where you will find people and organizations involved with this study.

Sponsor

The Comprehensive and Integrative Medicine Institute of South Korea

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Anticipated)

September 1, 2015

Study Completion (Anticipated)

September 1, 2015

Study Registration Dates

First Submitted

October 2, 2014

First Submitted That Met QC Criteria

October 9, 2014

First Posted (Estimate)

October 10, 2014

Study Record Updates

Last Update Posted (Estimate)

October 10, 2014

Last Update Submitted That Met QC Criteria

October 9, 2014

Last Verified

October 1, 2014

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

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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