Recruiting
Phase 3

Acupuncture

Sponsor:

Alta Bates Summit Medical Center

Code:

NCT00658034

Conditions

Fatigue

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Not accepted

Interventions

Acupuncture

Placebo Acupuncture

Study Details

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.

Conditions

Fatigue

Study ID

NCT00658034

Start date

Apr, 2008

Status verified date

Oct, 2011

Completion date

Dec, 2011

Anticipated

Primary completion date

Dec, 2011

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: 1

Acupuncture

sham comparator: 2

Placebo Acupuncture

Interventions

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.

Primary outcome measure

  • To determine whether acupuncture reduces chronic fatigue after chemotherapy more effectively than placebo [ Time Frame: six weeks ]

Central Contacts and Locations

Central contacts

Amy Matecki, MD

(510) 204-6402MateckA@Sutterhealth.org

Nick Humphrey, BA

(510) 204-3428Humphrn2@sutterhealth.org

Locations

Alta Bates Summit Comprehensive Cancer Center

Recruiting

Berkeley, California, United States, 94704

Contacts

Clinical Trials Office

510-204-3428

Principal Investigator:

Amy Matecki, MD

More Information

Sponsor

Alta Bates Summit Medical Center

Last update posted

Oct 26, 2011

Last verified

Oct, 2011

Keywords

  • Cancer
  • Fatigue
  • Acupuncture

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Alta Bates Summit Medical Center on 2011-10-26.