Acupuncture for the Treatment of Chronic Post-Chemotherapy Fatigue
NCT ID: NCT00658034
Last Updated: 2011-10-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
20 participants
INTERVENTIONAL
2008-04-30
2011-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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1
Acupuncture
Acupuncture
Subjects will receive acupuncture weekly for six weeks. Subjects will complete a Brief Fatigue Inventory (BFI) questionnaire, a Functional Assessment of Cancer Treatment scale (FACT-G), and a Hospital Anxiety and Depression Scale(HADS) at week 7. The BFI and FACT-G will be repeated at week 8. At the end of the study, subjects will be asked to state whether they thought they were on true or placebo acupuncture and why.
2
Placebo Acupuncture
Placebo Acupuncture
Subjects will receive placebo acupuncture weekly for six weeks. During the placebo phase, placebo acupuncture needles will be applied a few mm away from the required points. The placebo acupuncture needle is a blunt tipped needle that moves up inside its handle. When it is pressed against the skin, the subject feels a slight prick and sees the handle of the needle moving towards the skin as if the needle has been inserted.
Subjects will complete a BFI, a FACT-G, and a HADS at week 7. The BFI and FACT-G will be repeated at week 8. At the end of the study, subjects will be asked to state whether they thought they were on true or placebo acupuncture and why. Subjects in the placebo group will be given the option to receive true acupuncture.
Interventions
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Acupuncture
Subjects will receive acupuncture weekly for six weeks. Subjects will complete a Brief Fatigue Inventory (BFI) questionnaire, a Functional Assessment of Cancer Treatment scale (FACT-G), and a Hospital Anxiety and Depression Scale(HADS) at week 7. The BFI and FACT-G will be repeated at week 8. At the end of the study, subjects will be asked to state whether they thought they were on true or placebo acupuncture and why.
Placebo Acupuncture
Subjects will receive placebo acupuncture weekly for six weeks. During the placebo phase, placebo acupuncture needles will be applied a few mm away from the required points. The placebo acupuncture needle is a blunt tipped needle that moves up inside its handle. When it is pressed against the skin, the subject feels a slight prick and sees the handle of the needle moving towards the skin as if the needle has been inserted.
Subjects will complete a BFI, a FACT-G, and a HADS at week 7. The BFI and FACT-G will be repeated at week 8. At the end of the study, subjects will be asked to state whether they thought they were on true or placebo acupuncture and why. Subjects in the placebo group will be given the option to receive true acupuncture.
Eligibility Criteria
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Inclusion Criteria
* Patients must have received chemotherapy.
* Patients must complain of fatigue following chemotherapy buy not prior to chemotherapy.
* At least 60 days must have elapsed between the last chemotherapy infusion and completion of the first baseline questionnaire.
* Mean baseline fatigue as measured by the Brief Fatigue Inventory must be four or above.
Exclusion Criteria
* Platelets less than 50,000/microliter or an Absolute Neutrophil Count less than 1,000/microliter.
* Baseline depression score on the Hospital Anxiety and Depression Scale of 11 or above, indicating clinical depression.
* Thyroid disorder, defined as either thyroid stimulating hormone or free T4 out of normal range, is excluded as it is a possible cause of fatigue unrelated to cancer therapy.
* Surgery under general anesthesia; immunotherapy; radiotherapy; or initiation of hormonal therapy within the three weeks prior to enrollment.
* Acupuncture in the previous six weeks.
* Change in use of any of the following drugs in the prior three weeks: opiates, antidepressants (other than selective serotonin reuptake inhibitors \[SSRIs\])/anxiolytics; OR change in use of SSRIs in the prior six weeks. "Change in use" is defined as initiation or cessation of treatment, or change in prescribed dose or regimen: changes in actual amounts of PRN medication taken are allowed.
18 Years
64 Years
ALL
No
Sponsors
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Alta Bates Summit Medical Center
OTHER
Responsible Party
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Principal Investigators
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Amy Matecki, MD
Role: PRINCIPAL_INVESTIGATOR
Alta Bates Summit Comprehensive Cancer Center
Locations
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Alta Bates Summit Comprehensive Cancer Center
Berkeley, California, United States
Countries
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Central Contacts
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Facility Contacts
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Clinical Trials Office
Role: primary
Other Identifiers
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08-IM-01
Identifier Type: -
Identifier Source: org_study_id