Acupuncture for the Treatment of Chronic Post-Chemotherapy Fatigue
1 other identifier
interventional
20
1 country
1
Brief Summary
This is a randomized, placebo controlled study in cancer patients reporting fatigue persisting for at least two months following completion of chemotherapy. Subjects will receive 6 weeks of either acupuncture or placebo treatment as a means of evaluating whether acupuncture reduces chronic fatigue after chemotherapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Apr 2008
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2008
CompletedFirst Submitted
Initial submission to the registry
April 8, 2008
CompletedFirst Posted
Study publicly available on registry
April 14, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedOctober 26, 2011
October 1, 2011
3.7 years
April 8, 2008
October 25, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To determine whether acupuncture reduces chronic fatigue after chemotherapy more effectively than placebo
six weeks
Secondary Outcomes (3)
To examine the long term effects of acupuncture treatment on fatigue
six months
To examine predictors of response to acupuncture treatment in terms of baseline symptoms, hemoglobin, age, sex, time since chemotherapy, and concurrent treatment
six months
To examine the effect of acupuncture on levels of physical activity and quality of life
six months
Study Arms (2)
1
ACTIVE COMPARATORAcupuncture
2
SHAM COMPARATORPlacebo Acupuncture
Interventions
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.
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
You may qualify if:
- Patients age 18-64 diagnosed with a malignancy (solid tumor or hematologic malignancy).
- 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.
You may not qualify if:
- Anemia, defined as Hb\<9 or active treatment for anemia. Iron supplementation is allowed as long as the dose has been stable for at least six weeks.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Alta Bates Summit Comprehensive Cancer Center
Berkeley, California, 94704, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Amy Matecki, MD
Alta Bates Summit Comprehensive Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 8, 2008
First Posted
April 14, 2008
Study Start
April 1, 2008
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
October 26, 2011
Record last verified: 2011-10