Acupuncture for the Treatment of Chronic Post-Chemotherapy Fatigue

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

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.

Study Overview

• Status: Unknown
• Conditions: Fatigue
• Intervention / Treatment: Procedure: Acupuncture; Procedure: Placebo Acupuncture

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Amy Matecki, MD; Phone Number: (510) 204-6402; Email: MateckA@Sutterhealth.org
• Study Contact Backup: Name: Nick Humphrey, BA; Phone Number: (510) 204-3428; Email: Humphrn2@sutterhealth.org

Study Locations

• United States
  • California
    • Berkeley, California, United States, 94704
      • Recruiting
      • Alta Bates Summit Comprehensive Cancer Center
      • Contact: Clinical Trials Office; Phone Number: 510-204-3428
      • Principal Investigator: Amy Matecki, MD
      • Sub-Investigator: Ji Jill Chen, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To determine whether acupuncture reduces chronic fatigue after chemotherapy more effectively than placebo	six weeks

Secondary Outcome Measures

Outcome Measure	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
To examine the effect of acupuncture on levels of physical activity and quality of life	six months

Collaborators and Investigators

• Sponsor: Alta Bates Summit Medical Center
• Investigators: Principal Investigator: Amy Matecki, MD, Alta Bates Summit Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (Anticipated): December 1, 2011
• Study Completion (Anticipated): December 1, 2011

Study Registration Dates

• First Submitted: April 8, 2008
• First Submitted That Met QC Criteria: April 8, 2008
• First Posted (Estimate): April 14, 2008

Study Record Updates

• Last Update Posted (Estimate): October 26, 2011
• Last Update Submitted That Met QC Criteria: October 25, 2011
• Last Verified: October 1, 2011

More Information

Terms related to this study

• Keywords: Cancer; Acupuncture; Fatigue
• Additional Relevant MeSH Terms: Fatigue
• Other Study ID Numbers: 08-IM-01