CClinicalTrials.gg
Status unknownNCT00658034Updated Oct 26, 2011

Acupuncture for the Treatment of Chronic Post-Chemotherapy Fatigue

A Phase 3 interventional study of Acupuncture and Placebo Acupuncture in Fatigue, sponsored by Alta Bates Summit Medical Center. Status unknown at 1 site in United States. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2011-10-26.

Sponsored by Alta Bates Summit Medical Center · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2011), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 64 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Fatigue

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Keywords

  • Cancer
  • Fatigue
  • Acupuncture
03

In context

Fatigue

1,860 studies on the registry are indexed under Fatigue; 376 are open to participants now.

This study's planned enrollment of 20 is below the median of 54 across 1,440 interventional studies indexed under Fatigue.

Browse Fatigue studies →

Lead sponsor

Alta Bates Summit Medical Center is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
20 participants (estimated)

Study arms

  • Active comparator
    1

    Acupuncture

    Procedure: Acupuncture

  • Sham comparator
    2

    Placebo Acupuncture

    Procedure: Placebo Acupuncture

Interventions

  • ProcedureAcupuncture

    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.

  • ProcedurePlacebo 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.

06

What researchers measure

Primary outcomes

  1. To determine whether acupuncture reduces chronic fatigue after chemotherapy more effectively than placebo

    Time frame: six weeks

Secondary outcomes

  1. To examine the long term effects of acupuncture treatment on fatigue

    Time frame: six months

  2. 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

  3. To examine the effect of acupuncture on levels of physical activity and quality of life

    Time frame: six months

07

Study locations

1 of 1 sites recruiting
  • Alta Bates Summit Comprehensive Cancer Center
    Berkeley, California 94704, United States
    • Clinical Trials Office · Contact · 510-204-3428
    • Amy Matecki, MD · Principal investigator
    • Ji Jill Chen, MD · Sub investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 26, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00658034
Lead sponsor
Alta Bates Summit Medical Center
Responsible party
Sponsor
First posted
Apr 14, 2008
Start date
Apr 2008
Primary completion
Dec 2011 (estimated)
Completion
Dec 2011 (estimated)
Last update
Oct 26, 2011

Study contacts

Amy Matecki, MD
Contact
MateckA@Sutterhealth.org
(510) 204-6402
Nick Humphrey, BA
Contact
Humphrn2@sutterhealth.org
(510) 204-3428
Amy Matecki, MD
principal investigator · Alta Bates Summit Comprehensive Cancer Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2011. You cannot join it, but the record below documents what was studied.

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