CancerNCT02261571
Impact on Quality of Life by Moxibustion in Chemotherapy for Cancer
A study testing Moxibustion in people with Cancer, run by The Comprehensive and Integrative Medicine Institute of South Korea at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Cancer
- What is being tested?
- Moxibustion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2014to Sep 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Deagu Hanny University Medical center
Deagu, 704-123
Hyun Jung Jung, KMD, Ph. D
Kyung Soon Kim, KMD
About this study
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.
- Conditions
- Cancer
- Being tested
- Moxibustion
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MoxibustionOther
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
| Study group | Role | What they receive |
|---|---|---|
| Moxibustion | Experimental | A series of moxibustion sessions within six weeks from baseline with adjuvant chemotherapy. Receives: Other: Moxibustion |
| Waiting | No intervention | Participants who will be allocated to waitlist will receive no moxibustion treatments throughout the 6 weeks while receiving adjuvant chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
functional Assessment of Cancer Therapy: General (FACT-G)
Measured: change from baseline to 6 weeks
Secondary outcomes (3)
Body mass index
Measured: change from baseline to 6 weeks
immune function
lymphocyte panel(CD3,4,8,19,26), WBC, Differential count
Measured: change from baseline to 6 weeks
M.D, Anderson symptom Inventory (MDASI)
Measured: change from baseline to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionSep 2015 (estimated)
- Study completionSep 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Comprehensive and Integrative Medicine Institute of South Korea
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyun jung, Jung, The Comprehensive and Integrative Medicine Institute of South Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02261571
- Sponsor's protocol ID
- CIMI-14-01-08
- Status last verified
- Oct 2014
- First submitted
- 2 Oct 2014
- Last updated
- 10 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 21054851Lee 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.
PubMed 20374659
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Estimate the Efficacy of Moxibustion Stimulation at Abdominal Acupoints on Quality of Life in Cancer Patients Under Chemotherapy
- ClinicalTrials.gov ID
- NCT02261571
- Acronym / sponsor ID
- CIMI-14-01-08
- Conditions
- Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The Comprehensive and Integrative Medicine Institute of South KoreaUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Sep 2015 (estimated)
- Study completion
- Sep 2015 (estimated)
- First posted
- 10 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moxibustion | Experimental | Other: MoxibustionA series of moxibustion sessions within six weeks from baseline with adjuvant chemotherapy. |
| Waiting | No intervention | –Participants who will be allocated to waitlist will receive no moxibustion treatments throughout the 6 weeks while receiving adjuvant chemotherapy |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MoxibustionIn 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 | Other | Moxibustion |
Primary outcome
functional Assessment of Cancer Therapy: General (FACT-G)
Time frame: change from baseline to 6 weeks
3 secondary outcomes
Body mass index
Time frame: change from baseline to 6 weeks
immune function
Time frame: change from baseline to 6 weeks
M.D, Anderson symptom Inventory (MDASI)
Time frame: change from baseline to 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2014.
- Background: PubMed 21054851Lee 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.
- Background: PubMed 20374659Lee 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moxibustion in people with Cancer, run by The Comprehensive and Integrative Medicine Institute of South Korea at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hyun Jung Jung, KMD, Ph. D (+82537702082, koreancarmen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
functional Assessment of Cancer Therapy: General (FACT-G) (time frame: change from baseline to 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02261571, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2014.