Skip to main content
OpenTrials
Completed

NCT Number: NCT00825682

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

21 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Sheba Hospital,

Ramat Gan, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Foot massage

Primary outcomes

  1. The 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

    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.

Secondary outcomes

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

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

    The questionnaire includes 33 items describing different forms in which the disease may affect patient's quality of life. For each item, subjects are asked to mark the number that best describes their feelings right now, in a Likert scale ranging between 0 and 10. Items include happiness feelings, anxiety levels, how affected are the social ties because of the disease, etc.

    A total quality of life score was calculated as the average of all 33 items (ranging between 0 and 10), higher scores indicating a better quality of life.

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

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

    examines several aspects of sleep disorders and includes 21 items that describe feelings and behaviors associated with sleep during the last week. It uses a 0 (never) to 7 (every day) Likert scale on questions like feeling nervous during the day; falling asleep while unplanned and using sleeping pills.

    A total sleep disturbance score was calculated as the average of all 21 items (ranging between 0 and 7), higher scores indicating a worse outcome.

Sponsors and collaborators

Lead sponsor

Sheba Medical Center

Other Gov

Collaborators

  • Tel Aviv University

Registry information

Official study title

The Effect of Reflexology on Radiation-related Fatigue and QOL in Breast Cancer Patients: a Pilot Study.

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jan 21, 2009
Registry last updated
Dec 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.