Acupuncture for Joint Symptoms in Patients With Breast Cancer

NCT03836872 | Terminated DMC

• 1 other identifier: HSEARS20180509004
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Female Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Brief Pain Inventory

  Pain assessment measuring intensity of pain and impact of pain on daily functions. All items on a 0-10 numerical rating scale. Higher scores indicate worse pain and worse impact in daily lives.

  6-week assessment

Secondary Outcomes (20)

• Manchester Foot Pain Disability Questionnaire

  6-week assessment

• Manchester Foot Pain Disability Questionnaire

  12-week assessment

• Manchester Foot Pain Disability Questionnaire

  20-week assessment

• Michigan Hand Outcomes Questionnaire

  6-week assessment

• Michigan Hand Outcomes Questionnaire

  12-week assessment

Other Outcomes (1)

• Questionnaire for Patient Sociodemographic and Clinical Characteristics

  baseline assessment

Study Arms (3)

True Acupuncture

EXPERIMENTAL

Patients in the experimental group will receive, in addition to standard care, a standardised 30-minute acupuncture session needling specific acupoints. Bilateral acupoints will be stimulated including 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.

Device: Acupuncture

Sham Acupuncture

SHAM COMPARATOR

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

Device: Acupuncture

Standard Control Group

NO INTERVENTION

The third arm will be a standard care control arm.

Interventions

Acupuncture DEVICE

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.

Sham Acupuncture; True Acupuncture

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• BC patients with a confirmed diagnosis of hormone receptor-positive BC at the stage of I, II or IIIa;
• Patients who have completed taxane-based chemotherapy and are currently undergoing hormone treatments for at least three months;
• Patients indicate ongoing joint symptoms, including joint pain and/or stiffness, at one or more sites of body;
• Patients started to experience the joint symptoms after the commencement of the hormone treatments;
• 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;
• Patients have at least a primary school education and are able to communicate in Chinese Mandarin or Sichuanese; and
• Patients agree to participate in the trial and are willing to give written informed consent.

You may not qualify if:

• Patients who had needle phobia and a low count of platelet of less than 50,000;
• 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;
• Patients who had received joint surgery or had bone fracture during the past six months;
• Patients who had received any types of acupoint stimulation (e.g. body acupuncture or acupressure and auricular therapy) during the past six months; and
• Patients are currently treated with narcotic analgesia or steroids.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead
• The Affiliated Hospital Of Southwest Medical University: collaborator

Study Sites (1)

Xianliang Liu

Luzhou, China

Location

Related Publications (20)

• Cleeland, C.S., Pain assessment in cancer. In: D. Osoba (Ed.), Effect of Cancer on Quality of Life, CRC Press, Boca Raton, FL, 1991, 293-305.

  BACKGROUND

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  BACKGROUND

MeSH Terms

Interventions

Acupuncture Therapy

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Alex Molassiotis, PhD

  The Hong Kong Polytechnic University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair Professor of Nursing and Head

Study Record Dates

• First Submitted: February 1, 2019
• First Posted: February 11, 2019
• Study Start: March 1, 2019
• Primary Completion: January 10, 2022
• Study Completion: January 31, 2022
• Last Updated: August 25, 2022

Record last verified: 2022-08

Locations

CN (1)