NCT02261571

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable cancer

Timeline
Completed

Started Oct 2014

Shorter than P25 for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

October 2, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 10, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

October 10, 2014

Status Verified

October 1, 2014

Enrollment Period

11 months

First QC Date

October 2, 2014

Last Update Submit

October 9, 2014

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

  • functional Assessment of Cancer Therapy: General (FACT-G)

    change from baseline to 6 weeks

Secondary Outcomes (3)

  • Body mass index

    change from baseline to 6 weeks

  • immune function

    change from baseline to 6 weeks

  • M.D, Anderson symptom Inventory (MDASI)

    change from baseline to 6 weeks

Study Arms (2)

Moxibustion

EXPERIMENTAL

A series of moxibustion sessions within six weeks from baseline with adjuvant chemotherapy.

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

Interventions

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

Moxibustion

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Deagu Hanny University Medical center

Deagu, 704-123, South Korea

Location

Related Publications (2)

  • 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.

    PMID: 21054851BACKGROUND

  • 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.

    PMID: 20374659BACKGROUND

MeSH Terms

Conditions

Neoplasms

Interventions

Moxibustion

Intervention Hierarchy (Ancestors)

Acupuncture TherapyComplementary TherapiesTherapeutics

Central Study Contacts

Hyun Jung Jung, KMD, Ph. D

CONTACT

+82537702082koreancarmen@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

October 2, 2014

First Posted

October 10, 2014

Study Start

October 1, 2014

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

October 10, 2014

Record last verified: 2014-10

Locations

KR(1)