Acupuncture or Self-Acupuncture in Managing Cancer-Related Fatigue in Women Who Have Received Chemotherapy for Stage I, Stage II, or Stage IIIA Breast Cancer

NCT00957112 | Completed Phase 3

• 3 other identifiers: CDR0000649750UM-ASAEU-20970
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Acupuncture may help relieve fatigue caused by breast cancer. It is not yet known whether acupuncture is more effective than self-acupuncture in managing fatigue in women with breast cancer. PURPOSE: This randomized phase III trial is studying acupuncture to see how well it works compared with self-acupuncture in managing cancer-related fatigue in women who have received chemotherapy for stage I, stage II, or stage IIIA breast cancer.

Conditions

Anxiety Disorder; Breast Cancer; Depression; Fatigue

Keywords

anxiety disorder; depression; fatigue; stage IA breast cancer; stage IB breast cancer; stage II breast cancer; stage IIIA breast cancer

Outcome Measures

Primary Outcomes (1)

• General fatigue as measured by the Multidimensional Fatigue Inventory

Secondary Outcomes (4)

• Mental fatigue as measured by the Multidimensional Fatigue Inventory

• Anxiety as measured by the Hospital Anxiety and Depression Scale

• Depression as measured by the Hospital Anxiety and Depression Scale

• Quality of life as measured by the FACT-G and Breast Cancer module

Study Arms (5)

Arm I

EXPERIMENTAL

Patients undergo a 20-minute acupuncture session once a week for 6 weeks. Patients also receive written information about fatigue and its possible management.

Procedure: acupuncture therapy

Arm II

NO INTERVENTION

Patients receive standard care. They also receive written information about fatigue as in arm I.

Procedure: standard follow-up care

Arm A

EXPERIMENTAL

Patients receive treatment as in arm I for 4 more weeks.

Procedure: acupuncture therapy

Arm B

NO INTERVENTION

Patients receive standard care as in arm II for 4 more weeks.

Procedure: standard follow-up care

Arm C

EXPERIMENTAL

Patients learn to self-acupuncture and do so weekly for 4 more weeks.

Procedure: acupuncture therapy

Interventions

acupuncture therapy PROCEDURE

Patients undergo therapist-acupuncture with or without self-acupuncture

Arm A; Arm C; Arm I

standard follow-up care PROCEDURE

Patients receive standard care

Arm B; Arm II

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Diagnosis of breast cancer * Stage I, II, or IIIA disease * Completed prior chemotherapy for ≥ 1 month and up to 5 years * No needling on the ipsilateral arm of patients who have undergone axillary dissection * No needling on the lymphedematous limbs * Score of ≥ 5 on a 0-10 single-item screening fatigue scale, where 0 is no fatigue at all and 10 is extremely fatigued * Hormone receptor status not specified PATIENT CHARACTERISTICS: * Life expectancy ≥ 6 months * Menopausal status not specified * Platelet count ≥ 50,000/mm\^3 * Hemoglobin ≥ 10 g/dL * Hematocrit ≥ 30% * Not pregnant * No needle phobia * No co-morbidity with any of the following: * Bleeding disorder * Thyroid dysfunction PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No planned concurrent chemoradiotherapy * No concurrent steroids * No concurrent epoetin alfa or transfusion for anemia * No other concurrent complementary therapies

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Manchester: lead

Study Sites (1)

University of Manchester

Manchester, England, M13 9PL, United Kingdom

Location

Related Publications (2)

• Molassiotis A, Bardy J, Finnegan-John J, Mackereth P, Ryder WD, Filshie J, Ream E, Eaton D, Richardson A. A randomized, controlled trial of acupuncture self-needling as maintenance therapy for cancer-related fatigue after therapist-delivered acupuncture. Ann Oncol. 2013 Jun;24(6):1645-52. doi: 10.1093/annonc/mdt034. Epub 2013 Feb 21.

  PMID: 23436910 DERIVED

• Molassiotis A, Bardy J, Finnegan-John J, Mackereth P, Ryder DW, Filshie J, Ream E, Richardson A. Acupuncture for cancer-related fatigue in patients with breast cancer: a pragmatic randomized controlled trial. J Clin Oncol. 2012 Dec 20;30(36):4470-6. doi: 10.1200/JCO.2012.41.6222. Epub 2012 Oct 29.

  PMID: 23109700 DERIVED

MeSH Terms

Conditions

Anxiety Disorders; Breast Neoplasms; Depression; Fatigue

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Mental Disorders; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavioral Symptoms; Behavior; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Alex Molassiotis, MD

  University of Manchester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 11, 2009
• First Posted: August 12, 2009
• Study Start: October 1, 2007
• Primary Completion: October 1, 2010
• Study Completion: February 1, 2013
• Last Updated: August 26, 2013

Record last verified: 2009-08

Locations

GB (1)