None listed
Conditions
Brief summary
This pilot study looks at the effectiveness of acupuncture to reduce fatigue in women after treatment for breast cancer. You can join this study if you have recently been treated for breast cancer with chemotherapy, and you are suffering from fatigue associated with this treatment. Participants will be divided into three groups: an acupuncture treatment group, a placebo acupuncture group and a wait-list control group. Both the acupuncture and the placebo acupuncture groups will receive a type of acupuncture twice weekly over the first three weeks and then weekly for the final three weeks, with each treatment lasting 45 minutes. The placebo group will use a device which has a guide tube making it impossible for the subject to see whether the needle has penetrated the skin or not. Needle penetration does not occur. The sham needle will be placed away from acupuncture points. The wait list control group will receive no treatment for 6 weeks but will answer questionnaires during this time and be offered acupuncture treatment at the end of the 6 week study period. From 25% to 99% of people receiving cancer treatment suffer from fatigue. Preliminary reports suggest that acupuncture may help improve quality of life. The results of this study will be used in the design of a larger trial on the use of acupuncture to support cancer care.
Interventions
Study group 1: Traditional acupuncture with primary acupuncture points Kidney 3, Stomach 36, Spleen 6, Conception Vessel 6. Colon 4. These points have been used in previous research suggesting a therapeutic effect on fatigue in general. In addition secondary points will be administered based on a diagnosis used in Traditional Chinese Medicine. This design is similar to for example a psychiatrist who may diagnose a patient with the same condition yet use a different intervention due to varying cl
Study group 1: Traditional acupuncture with primary acupuncture points Kidney 3, Stomach 36, Spleen 6, Conception Vessel 6. Colon 4. These points have been used in previous research suggesting a therapeutic effect on fatigue in general. In addition secondary points will be administered based on a diagnosis used in Traditional Chinese Medicine. This design is similar to for example a psychiatrist who may diagnose a patient with the same condition yet use a different intervention due to varying clinical features. Treatment will be administered twice weekly over the first three weeks and then weekly for the final three weeks. Duration of each treatment 45 minutes. Acupuncture needles will be inserted to tissue level and stimulated manually. The needles will be stimulated once more during this treatment session. Single-use disposable stainless steel needles (0.25 x 40mm for body acupuncture) will be used. All points will be located according to the World Health Organisation International Standard Acupuncture Point Locations that was agreed on at Tsukuba, Japan, November, 2006. The intervention commences four weeks post cancer treatment.
Sponsors
University of Western Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Women with a diagnosis of breast cancer, and a score of four or greater on the Brief fatigue inventory (BFI), completed cytotoxic chemotherapy at least one month previously, and the ability to provide informed written consent. The fatigue has to be associated with cancer treatment (experienced only since receiving treatment for breast cancer) and not general fatigue.
Exclusion criteria
Women with severe anaemia defined as haemoglobin less than 9 g/dL or active treatment for anaemia, anticipated survival less than three months, no scheduled chemotherapy or radiotherapy during the study, fatigue prior to cancer diagnosis, or concurrent use of acupuncture.
Outcome results
None listed