The Effect of Reflexology on Radiation-related Fatigue in Breast Cancer Patients

NCT00825682 | Completed Phase 1 Results

• 1 other identifier: SHEBA-07-4923-DG-CTIL
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fatigue

Keywords

Breast cancer; Radiation therapy; Reflexology; Fatigue; Quality of life; Sleep disturbance

Outcome Measures

Primary Outcomes (1)

• The Lee Fatigue Scale

  The Lee Fatigue Scale consists of 18 items related to fatigue and energy: 13 items in the fatigue subscale and 5 items in the energy subscale. The mean of the 13 items in the fatigue subscale (range from 0-10) and the mean of the 5 items in the energy subscale (range from 0-10) are calculated. Higher scores indicate higher levels of perceived fatigue and energy . Items in the energy subscale were recoded, and a Lee fatigue total score was calculated as the average of all 18 items (ranging between 0 and 10), higher scores indicating higher levels of fatigue. The Cronbach's Alpha reliability coefficient of the English version of the questionnaire is 0.77 . The questionnaire's validity and reliability have been established in cancer patients.

  Beginning of study (initiation of radiation therapy and reflexology), 5 weeks after start (end of radiation therapy), 10 weeks after start

Secondary Outcomes (2)

• The Multidimensional Quality of Life Scale Cancer MQOLS-CA Was Written by Padilla (1992) and Translated Into Hebrew by Dorit Pud (2007).

  Beginning of study (initiation of radiation therapy and reflexology), 5 weeks after start (end of radiation therapy), 10 weeks after start

• The General Sleep Disturbance Scale (GSDS), Compiled by Lee (1992) and Translated Into Hebrew by Dr. Dorit Pud (2007)

  Beginning of study (initiation of radiation therapy and reflexology), 5 weeks after start (end of radiation therapy), 10 weeks after start

Study Arms (2)

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.

2

NO INTERVENTION

20 breast cancer patients, scheduled for adjunctive radiation treatment, matched by age to the intervention group will receive treatment as usual, and will be evaluated by the same measures as the intervention group.

Interventions

Reflexology treatment. OTHER

Reflexology treatments (45 min. each) will be initiated at the beginning of radiation therapy, once a week, for 10 weeks.The treatment includes manual pressure on specific points of foot soles and massage of the calf area, adapted individually to each patient.

Also known as: Foot massage

1

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Breast cancer adult patients scheduled to receive adjuvant radiation therapy

You may not qualify if:

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

Sponsors & Collaborators

• Sheba Medical Center: lead
• Tel Aviv University: collaborator

Study Sites (1)

Sheba Hospital,

Ramat Gan, Israel

Location

Related Publications (5)

• 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.

  PMID: 15524070 BACKGROUND

• 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. doi: 10.1089/jpm.2004.7.791.

  PMID: 15684846 BACKGROUND

• 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. doi: 10.4040/jkan.2005.35.1.177. Korean.

  PMID: 15778569 BACKGROUND

• 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. doi: 10.1016/j.jpainsymman.2003.12.016.

  PMID: 15336336 BACKGROUND

• 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. doi: 10.1111/j.1365-2934.2006.00557.x.

  PMID: 16487421 BACKGROUND

MeSH Terms

Conditions

Fatigue; Breast Neoplasms; Parasomnias

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Limitations and Caveats

This was a pilot non-randomized controlled study, with a relatively small sample and a single therapist.The control group received no additional intervention.

Results Point of Contact

• Title: Dr Dorit Gamus
• Organization: Sheba Medical Center

dorit.gamus@sheba.health.gov.il

+972-3-5303956

Study Officials

• Dorit D Gamus, MD, PhD

  Sheba Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Complementary Medicine Service

Study Record Dates

• First Submitted: January 19, 2009
• First Posted: January 21, 2009
• Study Start: May 1, 2008
• Primary Completion: February 1, 2009
• Study Completion: May 1, 2009
• Last Updated: December 8, 2016
• Results First Posted: December 8, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)