FatigueNCT00646633
Improving Fatigue: A Pilot Study of Acupuncture and Patient Education for Breast Cancer Survivors
A study testing Acupuncture and patient education in people with Fatigue, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
Trial summary
Based on the investigators clinical experience in patients with chronic disease (Hui, Hui, and Johnston, 2006; Hays et al 2005), a review of the literature (Johnston, Xiao and Hui 2007), and inspired by Vickers and colleagues (PMID: 15117996), the investigators carry out a pilot study that investigates if acupuncture… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Fatigue
- What is being tested?
- Acupuncture and patient education
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Oct 2009
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is between 18 and 65 years of age
- Patient has a rounded Brief Fatigue Inventory score of 4 or greater
- Patient is in a stable clinical condition
Who cannot join
- Severe anemia (hemoglobin level less than 9 g/dL, hematocrit level less than 30, decline in hemoglobin of 2 g/dL in the previous month, or active treatment for anemia)
- Karnofsky Performance Status below 70
- Acupuncture treatment in the previous 6 months
- Fatigue before cancer diagnosis
- Patient is mentally incapacitated or unfit to provide informed consent or participate in an interview
- Patient has the potential for serious bleeding due to inherited diseases such as hemophilia
- Patient is taking medications that are either fatigue-inducing or have sedating properties
- Patient is unavailable by telephone
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA Center for East-West Medicine
Santa Monica, California, 90404
About this study
Based on the investigators clinical experience in patients with chronic disease (Hui, Hui, and Johnston, 2006; Hays et al 2005), a review of the literature (Johnston, Xiao and Hui 2007), and inspired by Vickers and colleagues (PMID: 15117996), the investigators carry out a pilot study that investigates if acupuncture combined with patient education will relieve fatigue in patients who have completed primary treatment for breast cancer.
Read the detailed description
Patients will be randomly assigned to one of the two groups. Our hypothesis is that patients in the acupuncture/education group will experience greater relief of fatigue than those in the standard care group.
- Conditions
- Fatigue
- Being tested
- Acupuncture and patient education
- Keywords
- Cancer, Acupuncture
- Medical subject headings
- Fatigue, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acupuncture and patient educationProcedure or surgery
Also called Traditional Chinese Medicine, Integrative East-West Medicine
Acupuncture involves the insertion of extremely thin needles, much thinner than those used for drawing blood, into very specific acupuncture points. Patients will receive a total of 8 acupuncture treatments, each lasting 50 minutes. Patient education will be delivered to individuals over the course of approximately 50 minutes for each of the four sessions; topics will include acupressure, nutrition, exercise, stress management, and lifestyle advice.
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture & educ | Active comparator | Patients will receive a total of 8 acupuncture treatments. In each of the first four sessions, they will also receive patient education. Receives: Procedure: Acupuncture and patient education |
| 2. Standard care | No intervention | Patients in the control arm will continue to receive standard care from their physician. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue as measured by the Brief Fatigue Inventory
Measured: prior to beginning of treatment and after treatment ends. Up to an average of 44 weeks.
Secondary outcomes (3)
Health-Related Quality of Life (HRQoL) as measured by the SF36
Measured: prior to beginning of treatment and after end of treatment. Up to an average of 44 weeks.
Pain as measured by an analog scale
Measured: prior to beginning of treatment and after conclusion of treatment. Up to an average of 44 weeks.
Cognitive complaints as measured by the FACT-COG
Measured: prior to the beginning of treatment and after end of treatment. Up to an average of 44 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2008 (estimated)
- Study startMar 2008
- Primary completionJan 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for FatigueStudies of the same condition, open and under way.
- More trials run by Jonsson Comprehensive Cancer CenterThe sponsor's other registered studies.
- 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Susan G. Komen Breast Cancer Foundation
- Responsible party
- Sponsor
- Investigators
- Ka-Kit Hui, M.D., Principal investigator, UCLA Center for East-West Medicine, 1033 Gayley Ave, Suite 111, Los Angeles, CA 90024
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00646633
- Sponsor's protocol ID
- 06-08-010
- Status last verified
- Mar 2008
- First submitted
- 25 Mar 2008
- Last updated
- 7 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hui KK, Hui EK, Johnston MF. The potential of a person-centered approach in caring for patients with cancer: a perspective from the UCLA center for East-West medicine. Integr Cancer Ther. 2006 Mar;5(1):56-62. doi: 10.1177/1534735405286109.
PubMed 16484714Hays RD, Brodsky M, Johnston MF, Spritzer KL, Hui KK. Evaluating the statistical significance of health-related quality-of-life change in individual patients. Eval Health Prof. 2005 Jun;28(2):160-71. doi: 10.1177/0163278705275339.
PubMed 15851771Johnston MF, Xiao B, Hui KK. Acupuncture and fatigue: current basis for shared communication between breast cancer survivors and providers. J Cancer Surviv. 2007 Dec;1(4):306-12. doi: 10.1007/s11764-007-0035-9. Epub 2007 Oct 31.
PubMed 18648966Vickers AJ, Straus DJ, Fearon B, Cassileth BR. Acupuncture for postchemotherapy fatigue: a phase II study. J Clin Oncol. 2004 May 1;22(9):1731-5. doi: 10.1200/JCO.2004.04.102.
PubMed 15117996Johnston MF, Hays RD, Subramanian SK, Elashoff RM, Axe EK, Li JJ, Kim I, Vargas RB, Lee J, Yang L, Hui KK. Patient education integrated with acupuncture for relief of cancer-related fatigue randomized controlled feasibility study. BMC Complement Altern Med. 2011 Jun 25;11:49. doi: 10.1186/1472-6882-11-49.
PubMed 21703001
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Fatigue: A Pilot Study of Acupuncture and Patient Education for Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT00646633
- Acronym / sponsor ID
- 06-08-010
- Conditions
- Fatigue
- Keywords
- Cancer, Acupuncture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- Susan G. Komen Breast Cancer Foundation
- Study start
- Mar 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 28 Mar 2008 (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.
Based on the investigators clinical experience in patients with chronic disease (Hui, Hui, and Johnston, 2006; Hays et al 2005), a review of the literature (Johnston, Xiao and Hui 2007), and inspired by Vickers and colleagues (PMID: 15117996), the investigators carry out a pilot study that investigates if acupuncture combined with patient education will relieve fatigue in patients who have completed primary treatment for breast cancer.
Detailed description
Patients will be randomly assigned to one of the two groups. Our hypothesis is that patients in the acupuncture/education group will experience greater relief of fatigue than those in the standard care group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture & educ | Active comparator | Procedure: Acupuncture and patient educationPatients will receive a total of 8 acupuncture treatments. In each of the first four sessions, they will also receive patient education. |
| 2. Standard care | No intervention | –Patients in the control arm will continue to receive standard care from their physician. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient is between 18 and 65 years of age
- Patient has a rounded Brief Fatigue Inventory score of 4 or greater
- Patient is in a stable clinical condition
Key exclusion criteria (8 listed)
- Severe anemia (hemoglobin level less than 9 g/dL, hematocrit level less than 30, decline in hemoglobin of 2 g/dL in the previous month, or active treatment for anemia)
- Karnofsky Performance Status below 70
- Acupuncture treatment in the previous 6 months
- Fatigue before cancer diagnosis
- Patient is mentally incapacitated or unfit to provide informed consent or participate in an interview
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 |
|---|---|---|
| Acupuncture and patient educationAlso: Traditional Chinese Medicine, Integrative East-West MedicineAcupuncture involves the insertion of extremely thin needles, much thinner than those used for drawing blood, into very specific acupuncture points. Patients will receive a total of 8 acupuncture treatments, each lasting 50 minutes. Patient education will be delivered to individuals over the course of approximately 50 minutes for each of the four sessions; topics will include acupressure, nutrition, exercise, stress management, and lifestyle advice. | Procedure or surgery | Acupuncture & educ |
Primary outcome
Fatigue as measured by the Brief Fatigue Inventory
Time frame: prior to beginning of treatment and after treatment ends. Up to an average of 44 weeks.
3 secondary outcomes
Health-Related Quality of Life (HRQoL) as measured by the SF36
Time frame: prior to beginning of treatment and after end of treatment. Up to an average of 44 weeks.
Pain as measured by an analog scale
Time frame: prior to beginning of treatment and after conclusion of treatment. Up to an average of 44 weeks.
Cognitive complaints as measured by the FACT-COG
Time frame: prior to the beginning of treatment and after end of treatment. Up to an average of 44 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2016.
- Background: PubMed 16484714Hui KK, Hui EK, Johnston MF. The potential of a person-centered approach in caring for patients with cancer: a perspective from the UCLA center for East-West medicine. Integr Cancer Ther. 2006 Mar;5(1):56-62. doi: 10.1177/1534735405286109.
- Background: PubMed 15851771Hays RD, Brodsky M, Johnston MF, Spritzer KL, Hui KK. Evaluating the statistical significance of health-related quality-of-life change in individual patients. Eval Health Prof. 2005 Jun;28(2):160-71. doi: 10.1177/0163278705275339.
- Background: PubMed 18648966Johnston MF, Xiao B, Hui KK. Acupuncture and fatigue: current basis for shared communication between breast cancer survivors and providers. J Cancer Surviv. 2007 Dec;1(4):306-12. doi: 10.1007/s11764-007-0035-9. Epub 2007 Oct 31.
- Background: PubMed 15117996Vickers AJ, Straus DJ, Fearon B, Cassileth BR. Acupuncture for postchemotherapy fatigue: a phase II study. J Clin Oncol. 2004 May 1;22(9):1731-5. doi: 10.1200/JCO.2004.04.102.
- Derived from this study: PubMed 21703001Johnston MF, Hays RD, Subramanian SK, Elashoff RM, Axe EK, Li JJ, Kim I, Vargas RB, Lee J, Yang L, Hui KK. Patient education integrated with acupuncture for relief of cancer-related fatigue randomized controlled feasibility study. BMC Complement Altern Med. 2011 Jun 25;11:49. doi: 10.1186/1472-6882-11-49.
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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.
Ka-Kit Hui, M.D. principal investigator
UCLA Center for East-West Medicine, 1033 Gayley Ave, Suite 111, Los Angeles, CA 90024
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture and patient education in people with Fatigue, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
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 3 inclusion and 8 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: finished, as of the sponsor's last update on 7 Jul 2016. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue as measured by the Brief Fatigue Inventory (time frame: prior to beginning of treatment and after treatment ends. Up to an average of 44 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 NCT00646633, which also lists 5 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 7 Jul 2016.