Acupuncture for the Treatment of Chronic Post-Chemotherapy Fatigue

Fatigue Clinical Trial

Official title:

Acupuncture for the Treatment of Chronic Post-Chemotherapy Fatigue: a Randomized Phase III Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00658034
• Other study ID #: 08-IM-01
• Status: Recruiting
• Phase: Phase 3
• First received: April 8, 2008
• Last updated: October 25, 2011
• Start date: April 2008
• Est. completion date: December 2011

Study information

• Verified date: October 2011
• Source: Alta Bates Summit Medical Center
• Contact: Amy Matecki, MD
• Phone: (510) 204-6402
• Email: MateckA[@]Sutterhealth.org
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fatigue

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
United States	Alta Bates Summit Comprehensive Cancer Center	Berkeley	California

Sponsors (1)

Lead Sponsor	Collaborator
Alta Bates Summit Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine whether acupuncture reduces chronic fatigue after chemotherapy more effectively than placebo		six weeks	No
Secondary	To examine the long term effects of acupuncture treatment on fatigue		six months	No
Secondary	To examine predictors of response to acupuncture treatment in terms of baseline symptoms, hemoglobin, age, sex, time since chemotherapy, and concurrent treatment		six months	No
Secondary	To examine the effect of acupuncture on levels of physical activity and quality of life		six months	No