--- title: The Effect of Reflexology on Radiation-related Fatigue in Breast Cancer Patients nct_id: NCT00825682 overall_status: COMPLETED phase: PHASE1, PHASE2 sponsor: Sheba Medical Center study_type: INTERVENTIONAL primary_condition: Fatigue countries: Israel canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00825682.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00825682" ct_last_update_post_date: 2016-12-08 last_seen_at: "2026-05-12T06:10:57.285Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # The Effect of Reflexology on Radiation-related Fatigue in Breast Cancer Patients **Official Title:** The Effect of Reflexology on Radiation-related Fatigue and QOL in Breast Cancer Patients: a Pilot Study. **NCT ID:** [NCT00825682](https://clinicaltrials.gov/study/NCT00825682) ## Key Facts - **Status:** COMPLETED - **Phase:** PHASE1, PHASE2 - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 72 - **Lead Sponsor:** Sheba Medical Center - **Collaborators:** Tel Aviv University - **Conditions:** Fatigue - **Start Date:** 2008-05 - **Completion Date:** 2009-05 - **CT.gov Last Update:** 2016-12-08 ## 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. ## 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 - **Minimum age:** 21 Years - **Sex:** FEMALE - **Healthy Volunteers:** No ``` 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 ``` ## Arms - **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. - **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. ## Primary Outcomes - **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 - **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 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)_ ## Locations (1) - Sheba Hospital,, Ramat Gan, Israel ## Recent Field Changes (last 30 days) - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `sponsor.collaborators` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.sheba hospital,|ramat gan||israel` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT00825682.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT00825682* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*