Radiation Related Fatigue Clinical Trial
Official title:
The Effect of Reflexology on Radiation-Related Fatigue and QOL in Breast Cancer Patients: a Pilot Study.
| Verified date | July 2009 |
| Source | Sheba Medical Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Israel: Ministry of Health |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 40 |
| Est. completion date | May 2009 |
| Est. primary completion date | February 2009 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 21 Years and older |
| Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Israel | Sheba Hospital, | Ramat Gan |
| Lead Sponsor | Collaborator |
|---|---|
| Sheba Medical Center |
Israel,
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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. — View Citation
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. — View Citation
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Lee fatigue scale | Beginning of study (initiation of radiation therapy and reflexology), 5 weeks after start (end of radiation therapy), 10 weeks after start | No | |
| Secondary | Multidimensional Quality of Life Scale (MQOLS-CA) | As above | No | |
| Secondary | General Sleep Disturbance Scale | As above | No |