Objective
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To evaluate the psychoneuroimmunological effects of reflexology in women with early breast cancer.

Methods
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One hundred and eighty-three women with early breast cancer were randomised 6 weeks post surgery to self-initiated support (SIS) (comparator intervention), SIS plus reflexology, or SIS plus scalp massage (control for physical and social contact). Patients randomised to reflexology and massage had eight sessions at weekly intervals. Primary and secondary endpoints were 18 and 24 weeks post surgery, respectively. Mood, coping and quality of life were assessed pre-randomisation, and at the two endpoints. Blood was also taken at these three time points to enumerate lymphocyte subsets (CD profiles), cytokine production (Th1, Th2), and hormones (prolactin, cortisol, growth hormone).

Results
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At week 18, massage, but not reflexology, was significantly better than SIS in terms of the primary outcome measure, the Trial Outcome Index (TOI) of FACT-B. At the secondary endpoint (week 24), reflexology, but not massage, was better than SIS in terms of the TOI. Lymphocyte phenotyping found that CD25^+^cells were significantly higher in the massage group compared with the SIS group at week 24. The percentage of T cells, more specifically the T-helper subset expressing IL-4, decreased significantly in the massage group compared with the SIS group at week 24. An accompanying increase in the percentage of CD8^+^cytotoxic T cells expressing IFNγ in the massage group showed that the immunological balance of patients can be altered in a potentially beneficial manner by massage. Neither reflexology nor massage affected any of the lymphocyte subsets, or hormones.

Conclusions
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Reflexology and massage have modestly beneficial effects on quality of life. Massage showed statistically significant effects on immunological parameters, although the clinical significance of these effects will require further investigation.

Acknowledgements
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Funding from the NHS R&D cancer programme.
