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Trial record 1 of 1 for:    15778569 [PUBMED-IDS]
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The Effect of Reflexology on Radiation-related Fatigue in Breast Cancer Patients

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ClinicalTrials.gov Identifier: NCT00825682
Recruitment Status : Completed
First Posted : January 21, 2009
Results First Posted : December 8, 2016
Last Update Posted : December 8, 2016
Sponsor:
Collaborator:
Tel Aviv University
Information provided by (Responsible Party):
Dorit Gamus, Sheba Medical Center

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Fatigue
Intervention Other: Reflexology treatment.
Enrollment 72
Recruitment Details The study included 72 breast cancer patients, scheduled for complementary radiation therapy at the Cancer Center at Tel Hashomer Hospital during the years 2008-2011. Participants were recruited to the experimental and control groups, on a voluntary basis.
Pre-assignment Details Exclusion criteria: breast cancer patients with metastatic lesions on lower limbs, coagulation disorders and patients receiving other contact treatments.
Arm/Group Title Reflexology Group Control Group
Hide Arm/Group Description The experimental group included 47 women with breast cancer scheduled for adjunctive radiation treatment. The women received reflexology treatment initiated at the beginning of radiation therapy, once a week (45 min each), for 10 weeks. The control group (no intervention,treatment as usual)included 25 breast cancer patients, scheduled for adjunctive radiation treatment, who completed the same questionnaires at the same time points as the as the intervention group.
Period Title: Overall Study
Started 47 25
Completed 34 20
Not Completed 13 5
Reason Not Completed
personal reasons/ inconvenience             13             5
Arm/Group Title Reflexology Group Control Group Total
Hide Arm/Group Description The experimental group included 47 women with breast cancer scheduled for adjunctive radiation treatment. The women received reflexology treatment initiated at the beginning of radiation therapy, once a week (45 min each), for 10 weeks. The control group (no intervention,treatment as usual)included 25 breast cancer patients, scheduled for adjunctive radiation treatment, who completed the same questionnaires at the same time points as the as the intervention group. Total of all reporting groups
Overall Number of Baseline Participants 47 25 72
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 47 participants 25 participants 72 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
39
  83.0%
22
  88.0%
61
  84.7%
>=65 years
8
  17.0%
3
  12.0%
11
  15.3%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 47 participants 25 participants 72 participants
56  (9.47) 52.3  (11.78) 54.6  (10.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 47 participants 25 participants 72 participants
Female
47
 100.0%
25
 100.0%
72
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Israel Number Analyzed 47 participants 25 participants 72 participants
47 25 72
1.Primary Outcome
Title The Lee Fatigue Scale
Hide Description

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.

Time Frame Beginning of study (initiation of radiation therapy and reflexology), 5 weeks after start (end of radiation therapy), 10 weeks after start
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The final analysis included 33 women in the experimental group and 20 in the control group.
Arm/Group Title Reflexology Group Control Group
Hide Arm/Group Description:
The experimental group included 47 women with breast cancer scheduled for adjunctive radiation treatment. The women received reflexology treatment initiated at the beginning of radiation therapy, once a week (45 min each), for 10 weeks.
The control group (no intervention,treatment as usual)included 25 breast cancer patients, scheduled for adjunctive radiation treatment, who completed the same questionnaires at the same time points as the as the intervention group.
Overall Number of Participants Analyzed 33 20
Mean (Standard Deviation)
Unit of Measure: units on a scale
begining of the study 3.71  (1.76) 3.68  (1.56)
5 weeks 3.9  (1.57) 5.32  (1.61)
10 weeks 3.6  (1.45) 4.52  (2.05)
2.Secondary Outcome
Title The Multidimensional Quality of Life Scale Cancer MQOLS-CA Was Written by Padilla (1992) and Translated Into Hebrew by Dorit Pud (2007).
Hide Description

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.

Time Frame Beginning of study (initiation of radiation therapy and reflexology), 5 weeks after start (end of radiation therapy), 10 weeks after start
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The final ananlysis included 34 women in the experimental group, and 20 women in the control group.
Arm/Group Title Reflexology Group Control Group
Hide Arm/Group Description:
The experimental group included 47 women with breast cancer scheduled for adjunctive radiation treatment. The women received reflexology treatment initiated at the beginning of radiation therapy, once a week (45 min each), for 10 weeks. Five women did not begin the study and 8 women did not complete reflexology treatments due to personal reasons / inconvenience
The control group (no intervention,treatment as usual)included 25 breast cancer patients, scheduled for adjunctive radiation treatment, who completed the same questionnaires at the same time points as the as the intervention group.
Overall Number of Participants Analyzed 34 20
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
beginning of study 4.23  (1.36) 4.09  (1.13)
5 weeks 4.17  (1.25) 4.58  (1.09)
10 weeks 4.04  (1.25) 4.49  (1.02)
3.Secondary Outcome
Title The General Sleep Disturbance Scale (GSDS), Compiled by Lee (1992) and Translated Into Hebrew by Dr. Dorit Pud (2007)
Hide Description

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.

Time Frame Beginning of study (initiation of radiation therapy and reflexology), 5 weeks after start (end of radiation therapy), 10 weeks after start
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The final analysis included 34 women in the experimental group and 20 in the control group.
Arm/Group Title Reflexology Group Control Group
Hide Arm/Group Description:
The experimental group included 47 women with breast cancer scheduled for adjunctive radiation treatment. The women received reflexology treatment initiated at the beginning of radiation therapy, once a week (45 min each), for 10 weeks.
The control group (no intervention,treatment as usual)included 25 breast cancer patients, scheduled for adjunctive radiation treatment, who completed the same questionnaires at the same time points as the as the intervention group.
Overall Number of Participants Analyzed 34 20
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
beginning of study 2.51  (1.02) 2.35  (0.84)
5 weeks 2.27  (0.67) 2.67  (0.86)
10 weeks 2.19  (0.73) 2.49  (0.87)
Time Frame 10 weeks
Adverse Event Reporting Description no adverse effects were reported during the study
 
Arm/Group Title Reflexology Group Control Group
Hide Arm/Group Description The experimental group included 47 women with breast cancer scheduled for adjunctive radiation treatment. The women received reflexology treatment initiated at the beginning of radiation therapy, once a week (45 min each), for 10 weeks. The control group (no intervention,treatment as usual)included 25 breast cancer patients, scheduled for adjunctive radiation treatment, who completed the same questionnaires at the same time points as the as the intervention group.
All-Cause Mortality
Reflexology Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Reflexology Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/47 (0.00%)   0/25 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Reflexology Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/47 (0.00%)   0/25 (0.00%) 
This was a pilot non-randomized controlled study, with a relatively small sample and a single therapist.The control group received no additional intervention.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr Dorit Gamus
Organization: Sheba Medical Center
Phone: +972-3-5303956
Responsible Party: Dorit Gamus, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT00825682     History of Changes
Other Study ID Numbers: SHEBA-07-4923-DG-CTIL
First Submitted: January 19, 2009
First Posted: January 21, 2009
Results First Submitted: July 3, 2012
Results First Posted: December 8, 2016
Last Update Posted: December 8, 2016