None listed
Conditions
Brief summary
The primary purpose of this study is to investigate whether it is effective and feasible to treat post cancer related fatigue (CRF) using acupuncture. Who is it for? You may be eligible to join this study if you are aged 18 or over with ongoing cancer related fatigue and have been diagnosed with stage I, II or III breast cancer for which you have received breast surgery, adjuvant or neo-adjuvant chemotherapy and/or adjuvant radiotherapy between one month and two years previously with no recurrent disease since diagnosis. Study details Participants enrolled in this study will be randomly allocated (by chance) to receive either standard care as per usual or an eight week course of ten acupuncture sessions. The first session will include a traditional Chinese medicine (TCM) diagnosis and will take approximately 60-90 minutes in total. All remaining sessions will take approximately 45 minutes, using a minimum of five needle points at specified locations, and with a selection of pre-specified additional needle locations to use at the discretion of the acupuncture therapist based on the TCM diagnosis. Participants will be asked to complete a questionnaire prior to the first session and following the final treatment session to assess the severity of their CRF. Researchers will also use recruitment rates to assess whether it is feasible to conduct a larger study in the future. It is hoped that the findings of this study will provide greater understanding of the potential benefits of acupuncture for the treatment of CRF, and provide a foundation on which a larger study can be conducted.
Interventions
A semi-standardised treatment will be administered, this will allow for each participant to have a customized treatment within a standardized theory-driven framework. Participants will receive five points administered at each session (LI4, ST36, REN4, SP6, LI11). Participants will undergo a traditional Chinese medicine (TCM) diagnosis prior to the first treatments session. The diagnosis and treatment will follow an agreed algorithm and will take 60-90 minutes. The diagnosis will guide the custo
A semi-standardised treatment will be administered, this will allow for each participant to have a customized treatment within a standardized theory-driven framework. Participants will receive five points administered at each session (LI4, ST36, REN4, SP6, LI11). Participants will undergo a traditional Chinese medicine (TCM) diagnosis prior to the first treatments session. The diagnosis and treatment will follow an agreed algorithm and will take 60-90 minutes. The diagnosis will guide the customised acupuncture treatment.Additional points may be selected from the following list: SP9, GV14, SiShenCong, Du20, Lu7, Ht6, UB23, UB20, Liv3, P6, GB34, UB62, SI3. This first session will last 60-90 minutes. The needles will be retained in situ for a minimum of 20 minutes, with the duration of each treatment lasting 45 minutes. Single-use disposable stainless steel Serin needles (0.25 x 40mm and 0.22 x 25mm) will be used. All participants will receive the de qi sensation (a needling sensation of soreness, numbness or heaviness) following initial insertion and once more during treatment. Reinforcing or reducing stimulation will be given according to the TCM diagnoses. Needles will be inserted to depths according to standard texts. Participants will be offered 10 treatments with treatments commencing week one (one treatment), week two and three (twice weekly), week four to eight (once weekly). Treatment visits will be recorded to monitor adherence to the treatment protocol. This group receives both acupuncture and treatment as usual.
Sponsors
Western Sydney University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1) diagnosis of stage I, II, or III BC, who have completed breast surgery, adjuvant or neo-adjuvant chemotherapy and/or adjuvant radiotherapy between one month to 2 years prior to enrolment and who have not developed recurrent disease in the intervening period between diagnosis and study recruitment. 2) Taking adjuvant endocrine therapy and trastuzumab (Herceptin) are eligible 3) Ongoing cancer related fatigue, defined as a score of 4 or more on the fatigue sub scale of the Somatic and Psychological Health Report (SPHERE) questionnaire 4) Normal coagulation coagulation studies: PT, APTT, INR at baseline or within the previous 1 month. 5) Adequate haematological parameters at baseline or within the previous 1 month: Hb greater than 100, ANC greater than 1.0, Platelet count greater than 150.
Exclusion criteria
1) Co-morbid medical conditions expected to cause ongoing fatigue, (e.g.co-morbidity significant anaemia (defined as Hb less than 100) or thyroid disease) as assessed by the investigator. 2) Current use of acupuncture. 3) Needle phobia. 4) Concurrent treatment with medication interfering with blood clotting or bleeding time, including heparin and fractionated heparin, vitamin K antagonists, direct thrombin inhibiitors, factor Xa inhibitors, and antiplatelet agents. 5) Life expectancy less than six months. 6) Plan for major surgery during the time of the study e.g. breast reconstruction or re-excision. 7) History of other malignany within 5 years of recruitment, other than CIN of cervix or non-melanomatous skin cancers.
Outcome results
None listed