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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Acupuncture |
|
| 2 | Sham Comparator | Placebo Acupuncture |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupuncture | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| To determine whether acupuncture reduces chronic fatigue after chemotherapy more effectively than placebo | six weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amy Matecki, MD | Contact | (510) 204-6402 | MateckA@Sutterhealth.org | |
| Nick Humphrey, BA | Contact | (510) 204-3428 | Humphrn2@sutterhealth.org |
| Name | Affiliation | Role |
|---|---|---|
| Amy Matecki, MD | Alta Bates Summit Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alta Bates Summit Comprehensive Cancer Center | Recruiting | Berkeley | California | 94704 | United States |
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| ID | Term |
|---|---|
| D005221 | Fatigue |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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| Placebo Acupuncture | Procedure | 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. |
|
| To examine the effect of acupuncture on levels of physical activity and quality of life | six months |