The Effect of Reflexology on Radiation-Related Fatigue in Breast Cancer Patients - Full Text View

Sponsored by:	Sheba Medical Center
Information provided by:	Sheba Medical Center
ClinicalTrials.gov Identifier:	NCT00825682

Purpose

Oncologic patients often report increased fatigue during and after radiation therapy. Reflexology treatment has been demonstrated to alleviate symptoms of fatigue, nausea, and anxiety in oncologic patients treated with chemotherapy. The aim of the study is to evaluate the effect of reflexology on fatigue, quality of life, and quality of sleep of breast cancer patients during and after radiation therapy.

Condition	Intervention	Phase
Radiation Related Fatigue	Other: Reflexology treatment.	Phase I Phase II

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Radiation Therapy

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	The Effect of Reflexology on Radiation-Related Fatigue and QOL in Breast Cancer Patients: a Pilot Study.

Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:

Lee fatigue scale [ Time Frame: Beginning of study (initiation of radiation therapy and reflexology), 5 weeks after start (end of radiation therapy), 10 weeks after start ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Multidimensional Quality of Life Scale (MQOLS-CA) [ Time Frame: As above ] [ Designated as safety issue: No ]
General Sleep Disturbance Scale [ Time Frame: As above ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	May 2008
Estimated Study Completion Date:	May 2010
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 20 breast cancer patients scheduled for adjunctive radiation treatment will be recruited for this study to receive reflexology treatment initiated at the beginning of radiation therapy, once a week, for 10 weeks.	Other: Reflexology treatment. Reflexology treatments (45 min. each) will be initiated at the beginning of radiation therapy, once a week, for 10 weeks.
2: No Intervention 20 breast cancer patients, scheduled for adjunctive radiation treatment, matched by age to the intervention group, will be evaluated by the same measures as the intervention group.

Detailed Description:

Reflexology (foot massage) is a complementary medicine technique which is performed by manual pressure on specific areas of the feet. Reflexology is based on a system of zones and reflex areas that are believed to reflect an image of the body on the feet with a premise that such work effects a physical change to the body.

The effect of reflexology on fatigue, quality of life, and quality of sleep of 20 breast cancer patients during and after radiation therapy will be compared to age-matched control group of 20 breast cancer patients treated by radiation therapy.

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Breast cancer adult patients scheduled to receive adjuvant radiation therapy

Exclusion Criteria:

Open wounds or evidence of metastases on the lower limbs
Touch therapy or other complementary therapy other than intervention procedure

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00825682

Locations

Israel
Sheba Hospital,	Recruiting
Ramat Gan, Israel
Contact: Dorit Gamus, M.D., Ph.D. +972-3-5303956 dorit.gamus@sheba.health.gov.il
Sub-Investigator: Sarah Ben Ami, RN, MA
Sub-Investigator: Raphael Catane, MD
Sub-Investigator: Raphael Pfeffer, MD
Sub-Investigator: Bella Kaufman, MD
Sub-Investigator: Merav Ben-David, MD

Sponsors and Collaborators

Sheba Medical Center

More Information

Publications:

Deng G, Cassileth BR, Yeung KS. Complementary therapies for cancer-related symptoms. J Support Oncol. 2004 Sep-Oct;2(5):419-26; discussion 427-9. Review.

Kohara H, Miyauchi T, Suehiro Y, Ueoka H, Takeyama H, Morita T. Combined modality treatment of aromatherapy, footsoak, and reflexology relieves fatigue in patients with cancer. J Palliat Med. 2004 Dec;7(6):791-6.

Yang JH. [The effects of foot reflexology on nausea, vomiting and fatigue of breast cancer patients undergoing chemotherapy] Taehan Kanho Hakhoe Chi. 2005 Feb;35(1):177-85. Korean.

Cassileth BR, Vickers AJ. Massage therapy for symptom control: outcome study at a major cancer center. J Pain Symptom Manage. 2004 Sep;28(3):244-9.

Quattrin R, Zanini A, Buchini S, Turello D, Annunziata MA, Vidotti C, Colombatti A, Brusaferro S. Use of reflexology foot massage to reduce anxiety in hospitalized cancer patients in chemotherapy treatment: methodology and outcomes. J Nurs Manag. 2006 Mar;14(2):96-105.

Responsible Party:	Sheba Medical Center ( Dorit Gamus )
Study ID Numbers:	SHEBA-07-4923-DG-CTIL
Study First Received:	January 19, 2009
Last Updated:	January 20, 2009
ClinicalTrials.gov Identifier:	NCT00825682 History of Changes
Health Authority:	Israel: Ministry of Health

Keywords provided by Sheba Medical Center:

Breast cancer
Radiation therapy
Reflexology

Fatigue
Quality of life
Sleep disturbance

Study placed in the following topic categories:

Signs and Symptoms
Fatigue
Skin Diseases
Quality of Life

Dyssomnias
Sleep Disorders
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:

Signs and Symptoms
Neoplasms
Neoplasms by Site
Fatigue

Skin Diseases
Breast Neoplasms
Breast Diseases

ClinicalTrials.gov processed this record on May 07, 2009