Clinical trial NCT03836872: Acupuncture for Joint Symptoms in Patients With Breast Cancer
Official title: Acupuncture for Joint Symptoms in Patients With Breast Cancer: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Female Breast Cancer
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
Collaborators: name: The Affiliated Hospital Of Southwest Medical University
First posted: 2019-02-11
Enrollment: 64
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Joint symptoms including stiffness, local pain and aches are common adverse reactions among breast cancer (BC) patients undergoing hormone treatments, while effective interventions for managing such symptoms have not been well explored so far. Acupuncture can be a promising approach to controlling joint symptoms in BC patients but current research evidence generated from several small-scale clinical studies have not been robust enough to support the use of acupuncture for cancer symptom management in routine practice.

The overall aim of the research project is to examine the effectiveness of a 6-week acupuncture protocol for the management of joint symptoms in Chinese female BC patients who are currently undergoing hormone treatments following the completion of taxane-based chemotherapy. Given the lack of available data regarding the prevalence of joint symptoms in BC patients in mainland China, a large cross-sectional survey will also be performed to examine the incidence of joint symptoms among Chinese BC patients in mainland China and the impact of joint symptoms on patients' quality of life.

Detailed description: A three-group trial design is proposed, with an experimental group receiving true acupuncture at specific acupuncture points, a sham control group receiving sham acupuncture at non-acupuncture Acupoints with superficial needling, both in addition to routine methods of care, and a group receiving usual care only.

Participants and Settings BC patients who have completed taxane-based chemotherapy and are currently receiving hormone treatments with the experience of joint pain will be the targeted study population. The study will take place in the Southwest Medical University Hospital, a large medical centre in Sichuan, China.

Sample Size 55 per group (165 in total).

The Intervention Protocol

1. True Acupuncture Protocol will be used in the True Acupuncture Group (Experimental Group)

   The acupuncture intervention is described below based on the STRICTA recommendations for reporting acupuncture trials. Patients in the experimental group will receive, in addition to standard care, a standardised 30-minute acupuncture session needling specific acupoints although there will be flexibility in case some points cannot be punctured (e. g. in case of lymphoedema), and alternative points (as in routine practice) may be selected by the acupuncture practitioner using their discretion to maintain an equal dose of treatment to all patients. Bilateral acupoints will be stimulated. These points will include Waiguan (SJ5), Jianjing (GB21), Yanglingquan (GB34), Hegu (LI4), Jiexi (ST41) and Taixi (K3). In addition, joint specific acupoints will also be used, depending on where the joint symptoms are present. The additional acupoints will be:
   1. Shoulder (Bilateral Acupoints): Jianyu (LI15), Jianliao (SJ14), and Naoshu (SI10); The following alternative acupoints would be considered in case of some patients may have lymphoedema or other problem at particular sites where the above proposed acupoints cannot be stimulated: Quchi (LI11), Shousanli (LI10), Tianzong (SI11) and Taichong (LR3).
   2. Wrist (Bilateral Acupoints): Yangchi (SJ4), Yangxi (LI5), and Daling (PC7); The following alternative acupoints would be considered in case of some patients may have lymphoedema or other problem at particular sites where the above proposed acupoints cannot be stimulated: Zhigou (SJ6), Jianshi (PC5) and Wailaogong (EX-UE8).
   3. Fingers (Bilateral Acupoints): Yanggu (SI5), Houxi (SI3), and Sanjian (LI3); Alternative acupoints located on the wrist or forearm would be considered in case of some patients may have lymphoedema or other problem at particular sites where the above proposed acupoints cannot be stimulated.
   4. Lumbar Area (Bilateral Acupoints): Yaoyangguan (DU3), Jingsuo (DU8), and Shenyu (BL23); Alternative acupoint Weizhong (BL40) located on the wrist or forearm would be considered in case of some patients may have lymphoedema or other problem at particular sites where the above proposed acupoints cannot be stimulated.
   5. Hip (Bilateral Acupoints): Huantiao (GB30), Xuanzhong (GB39), and Juliao (GB29); The following alternative acupoints would be considered in case of some patients may have lymphoedema or other problem at particular sites where the above proposed acupoints cannot be stimulated: Fengshi (GB31) and Biguan (ST31).
   6. Knee (Bilateral Acupoints): Yinlingquan (SP9), Xuehai (SP10), and Liangqiu (ST34).

   The following alternative acupoints would be considered in case of some patients may have lymphoedema or other problem at particular sites where the above proposed acupoints cannot be stimulated: Heding (EX-LE2), Futu (ST32), Baichongwo (EX-LE3), and Xiyan (EX-LE5).

   Acupuncture will be twice a week for consecutive 6 weeks, thus a total of 12 sessions of acupuncture will be carried out.
2. Sham Acupuncture Protocol will be used in the Sham Acupuncture Group (Sham Control Group) In addition to the routine methods of care, patients allocated to the sham control group will receive sham acupuncture treatment at sham acupoints with superficial needling to avoid the generation of specific treatment effects. The sham acupoints selected for stimulation will be those located 1-3 cm near the true acupoints used in the true acupuncture group. The number of the selected sham acupoints will be the same as those used in the true acupuncture group. Meanwhile, to maintain the homogeneity of the routine methods of care used across groups, the conventional care for all the participants in this study will include at least written education materials in terms of the knowledge of joint symptoms and instructions of the use of painkillers and non-steroidal anti-inflammatory drugs (NSAIDs). During the whole study period, the study investigators will also record any other treatments, including other complementary and alternative approaches, that participants may receive and view as potential confounders in the data analysis stage. Given the design of true and sham acupuncture groups, participants, study investigators and outcome assessors will not know the actual group assignment of the true and sham acupuncture group, and a partial blinding design is therefore utilized for this proposed study.
3. Usual care wil be used in the waiting-list control group (Waiting-list Control Group) Participants in this group will only receive the usual care for the period that they are on the waiting list. But the waiting-list control group will offer acupuncture intervention after the completion of the RCT.

Study Duration and Outcome Assessment The total acupuncture treatment duration will be six weeks, and the duration of study involvement for each participant will be around 20 weeks including baseline assessment, immediate post-treatment assessment after the 6-week acupuncture, and two follow-up assessment at 12 weeks and 20 weeks, respectively.

Ethical Considerations A written informed consent will be obtained from every eligible person agreeing to participate after the risks and benefits of the study have been explained to them verbally and in writing. Participation in the study is on a voluntary basis, and all potential participants will be informed and assured that they have the right to refuse or withdraw from the study at any time. Personal information and data will remain confidential and anonymous. Side effects arising from acupuncture are rare. However, abnormal phenomena such as local tenderness, fainting, stuck needle, bent needle, broken needle, and haematoma during or after the procedure may be possible. Such conditions will be resolved quickly when the needles are removed, and the client's conditions will be monitored closely and recorded. Application for ethical approval from the Human Research Ethics Review Committee has been obtained from The Hong Kong Polytechnic University and the hospital where the trial will be carried out.

Data Analysis Analyses will include descriptive statistics to summarise the data, analysis of variance to assess between-groups differences, and regression analysis (such as ANCOVA) using the baseline pain score as covariate. 95% CIs will also be calculated. In more detail, while a t-test is adequate for analysis, analysis of covariance will be used with the baseline pain score as a covariate and centre and trial arm as grouping factors. Equivalent analyses will be performed for the week 20 data (although it is acknowledged that such analyses would not be independent of the 12-week scores, as it is likely the week-12 and week-20 values will be correlated). Drop-out cases and non-respondents will be asked to complete 1 item about their pain levels from the BPI scale to capture outcomes in as many patients as possible in the intention to treat analysis.

Significance and Implications Using robust methodology the study will investigate and interpret the use, delivery and outcomes of acupuncture in the management of a debilitating symptom of cancer therapies in order to inform decision-making and policy-making, and contribute to the evidence base for the treatment of hormone treatment-related joint symptoms. This study will provide information that can lead to improvements in the care of cancer patients, have a positive impact on quality of life and may increase the number of patients successfully completing hormone treatments. The project is about complementary therapies that many cancer patients frequently use, and has the potential to translate into benefits for patients fairly quickly. An information booklet on managing joint pains in breast cancer patients would also be a key outcome of the study.

Eligibility criteria: Inclusion Criteria:

1. BC patients with a confirmed diagnosis of hormone receptor-positive BC at the stage of I, II or IIIa;
2. Patients who have completed taxane-based chemotherapy and are currently undergoing hormone treatments for at least three months;
3. Patients indicate ongoing joint symptoms, including joint pain and/or stiffness, at one or more sites of body;
4. Patients started to experience the joint symptoms after the commencement of the hormone treatments;
5. Patients indicate the intensity of their worst pain during the past seven days of greater than 4 points at a 0-10 NRS scale where 0 represents no pain and 10 indicates most severe pain;
6. Patients have at least a primary school education and are able to communicate in Chinese Mandarin or Sichuanese; and
7. Patients agree to participate in the trial and are willing to give written informed consent.

Exclusion Criteria:

1. Patients who had needle phobia and a low count of platelet of less than 50,000;
2. Patients with conditions which are not appropriate for acupuncture including pregnancy, bleeding disorders, local or systematic inflammation, and other neuropathic and/or metabolic problems of the joints;
3. Patients who had received joint surgery or had bone fracture during the past six months;
4. Patients who had received any types of acupoint stimulation (e.g. body acupuncture or acupressure and auricular therapy) during the past six months; and
5. Patients are currently treated with narcotic analgesia or steroids.

Primary outcomes:
measure: Brief Pain Inventory
timeFrame: 6-week assessment
Secondary outcomes:
measure: Manchester Foot Pain Disability Questionnaire
timeFrame: 6-week assessment
measure: Manchester Foot Pain Disability Questionnaire
timeFrame: 12-week assessment
measure: Manchester Foot Pain Disability Questionnaire
timeFrame: 20-week assessment
measure: Michigan Hand Outcomes Questionnaire
timeFrame: 6-week assessment
measure: Michigan Hand Outcomes Questionnaire
timeFrame: 12-week assessment
measure: Michigan Hand Outcomes Questionnaire
timeFrame: 20-week assessment
measure: Western Ontario & McMaster Universities Osteoarthritis Index
timeFrame: 6-week assessment
measure: Western Ontario & McMaster Universities Osteoarthritis Index
timeFrame: 12-week assessment
measure: Western Ontario & McMaster Universities Osteoarthritis Index
timeFrame: 20-week assessment
measure: Arthritis Impact Measurement Scale 2-Short Form
timeFrame: 6-week assessment
measure: Arthritis Impact Measurement Scale 2-Short Form
timeFrame: 12-week assessment
measure: Arthritis Impact Measurement Scale 2-Short Form
timeFrame: 20-week assessment
measure: Functional Assessment of Cancer Therapy-Breast
timeFrame: 6-week assessment
measure: Functional Assessment of Cancer Therapy-Breast
timeFrame: 12-week assessment
measure: Functional Assessment of Cancer Therapy-Breast
timeFrame: 20-week assessment
measure: Medical Outcomes Survey 36-item short form version
timeFrame: 6-week assessment
measure: Medical Outcomes Survey 36-item short form version
timeFrame: 12-week assessment
measure: Medical Outcomes Survey 36-item short form version
timeFrame: 20-week assessment
measure: Brief Pain Inventory
timeFrame: 12 weeks assessment
measure: Brief Pain Inventory
timeFrame: 20 weeks assessment
Other outcomes:
measure: Questionnaire for Patient Sociodemographic and Clinical Characteristics
timeFrame: baseline assessment
Locations:
city: Luzhou
country: China
facility: Xianliang Liu
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Alex Molassiotis, PhD
role: STUDY_CHAIR
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