Acupuncture for the Treatment of Chronic Post-Chemotherapy Fatigue

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by Alta Bates Summit Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Alta Bates Summit Medical Center
ClinicalTrials.gov Identifier:
NCT00658034
First received: April 8, 2008
Last updated: October 25, 2011
Last verified: October 2011
  Purpose

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.


Condition Intervention Phase
Fatigue
Procedure: Acupuncture
Procedure: Placebo Acupuncture
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Acupuncture for the Treatment of Chronic Post-Chemotherapy Fatigue: a Randomized Phase III Trial

Resource links provided by NLM:


Further study details as provided by Alta Bates Summit Medical Center:

Primary Outcome Measures:
  • To determine whether acupuncture reduces chronic fatigue after chemotherapy more effectively than placebo [ Time Frame: six weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To examine the long term effects of acupuncture treatment on fatigue [ Time Frame: six months ] [ Designated as safety issue: No ]
  • To examine predictors of response to acupuncture treatment in terms of baseline symptoms, hemoglobin, age, sex, time since chemotherapy, and concurrent treatment [ Time Frame: six months ] [ Designated as safety issue: No ]
  • To examine the effect of acupuncture on levels of physical activity and quality of life [ Time Frame: six months ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: April 2008
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Acupuncture
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.
Sham Comparator: 2
Placebo Acupuncture
Procedure: 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

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00658034

Contacts
Contact: Amy Matecki, MD (510) 204-6402 MateckA@Sutterhealth.org
Contact: Nick Humphrey, BA (510) 204-3428 Humphrn2@sutterhealth.org

Locations
United States, California
Alta Bates Summit Comprehensive Cancer Center Recruiting
Berkeley, California, United States, 94704
Contact: Clinical Trials Office    510-204-3428      
Principal Investigator: Amy Matecki, MD         
Sub-Investigator: Ji Jill Chen, MD         
Sponsors and Collaborators
Alta Bates Summit Medical Center
Investigators
Principal Investigator: Amy Matecki, MD Alta Bates Summit Comprehensive Cancer Center
  More Information

No publications provided

Responsible Party: Alta Bates Summit Medical Center
ClinicalTrials.gov Identifier: NCT00658034     History of Changes
Other Study ID Numbers: 08-IM-01
Study First Received: April 8, 2008
Last Updated: October 25, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Alta Bates Summit Medical Center:
Cancer
Fatigue
Acupuncture

Additional relevant MeSH terms:
Fatigue
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014