Acupuncture to treat cancer related fatigue

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2015
INTERVENTION: 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. CONDITION: Anxiety Cancer fatigue Depression Health related quality of life PRIMARY OUTCOME: Number of women approached to obtain 20 randomisations? Assessed from notes in responses to interest from potential participants and outcomes from screening assessment.. ; Reasons for women not agreeing to participate? Assessed using notes to monitor outcomes from providing information to potential participants. Severity of CRF assessed using the Fatigue Functional Assessment of Chronic Illness Therapy‐ Fatigue Scale, and the Structured Clinical Interview for Neurasthenia. SECONDARY OUTCOME: Drop out rates, Assessed using notes to monitor outcomes from providing information to potential participants. Treatment acceptability. Assessed using notes to monitor outcomes from providing information to potential participants. Anxiety and depression measured using the DASS. Health related quality of life measured using the Functional Assessment of Cancer Therapy Breast Cancer, Numbers meeting eligibility criteria,. Assessed using notes to monitor outcomes from providing information to potential participants. 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.
Epistemonikos ID: 8abae495867a69bd0782335e87362c036f578e94
First added on: Aug 25, 2024