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Acupuncture for Joint Symptoms in Patients With Breast Cancer

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ClinicalTrials.gov Identifier: NCT03836872
Recruitment Status : Not yet recruiting
First Posted : February 11, 2019
Last Update Posted : February 15, 2019
Sponsor:
Collaborator:
The Affiliated Hospital Of Southwest Medical University
Information provided by (Responsible Party):
Professor Alex MOLASIOTIS, The Hong Kong Polytechnic University

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.


Condition or disease Intervention/treatment Phase
Female Breast Cancer Device: Acupuncture Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 165 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Acupuncture for Joint Symptoms in Patients With Breast Cancer: A Randomised Controlled Trial
Estimated Study Start Date : March 1, 2019
Estimated Primary Completion Date : August 1, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: True Acupuncture
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
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 Comparator: Sham Acupuncture
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
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.

No Intervention: Standard Control Group
The third arm will be a standard care control arm.



Primary Outcome Measures :
  1. Brief Pain Inventory [ Time Frame: 6-week assessment ]
    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.


Secondary Outcome Measures :
  1. Manchester Foot Pain Disability Questionnaire [ Time Frame: 6-week assessment ]
    Measures foot pain with 19 items and three dimensions (functioning limitations with 12 items; pain intensity with 4 items; personal appearance with 3 items). Higher scores indicate worse outcomes.

  2. Manchester Foot Pain Disability Questionnaire [ Time Frame: 12-week assessment ]
    Measures foot pain with 19 items and three dimensions (functioning limitations with 12 items; pain intensity with 4 items; personal appearance with 3 items). Higher scores indicate worse outcomes.

  3. Manchester Foot Pain Disability Questionnaire [ Time Frame: 20-week assessment ]
    Measures foot pain with 19 items and three dimensions (functioning limitations with 12 items; pain intensity with 4 items; personal appearance with 3 items). Higher scores indicate worse outcomes.

  4. Michigan Hand Outcomes Questionnaire [ Time Frame: 6-week assessment ]
    Assesses hand function with 37 items, and has 6 dimensions of hand functioning

  5. Michigan Hand Outcomes Questionnaire [ Time Frame: 12-week assessment ]
    Assesses hand function with 37 items, and has 6 dimensions of hand functioning

  6. Michigan Hand Outcomes Questionnaire [ Time Frame: 20-week assessment ]
    Assesses hand function with 37 items, and has 6 dimensions of hand functioning

  7. Western Ontario & McMaster Universities Osteoarthritis Index [ Time Frame: 6-week assessment ]
    Assesses 3 dimensions of osteoarthritis symptoms with 24 items, including joint pain, stiffness and disability. Higher scores are indicative of worse functioning and higher symptom burden.

  8. Western Ontario & McMaster Universities Osteoarthritis Index [ Time Frame: 12-week assessment ]
    Assesses 3 dimensions of osteoarthritis symptoms with 24 items, including joint pain, stiffness and disability. Higher scores are indicative of worse functioning and higher symptom burden.

  9. Western Ontario & McMaster Universities Osteoarthritis Index [ Time Frame: 20-week assessment ]
    Assesses 3 dimensions of osteoarthritis symptoms with 24 items, including joint pain, stiffness and disability. Higher scores are indicative of worse functioning and higher symptom burden.

  10. Arthritis Impact Measurement Scale 2-Short Form [ Time Frame: 6-week assessment ]
    Assesses arthritis-related quality of life with 26 items in 5 domains (physical functioning, symptoms, impact, social and functional dimensions), with higher scores indicating worse quality of life.

  11. Arthritis Impact Measurement Scale 2-Short Form [ Time Frame: 12-week assessment ]
    Assesses arthritis-related quality of life with 26 items in 5 domains (physical functioning, symptoms, impact, social and functional dimensions), with higher scores indicating worse quality of life.

  12. Arthritis Impact Measurement Scale 2-Short Form [ Time Frame: 20-week assessment ]
    Assesses arthritis-related quality of life with 26 items in 5 domains (physical functioning, symptoms, impact, social and functional dimensions), with higher scores indicating worse quality of life.

  13. Functional Assessment of Cancer Therapy-Breast [ Time Frame: 6-week assessment ]
    This is a disease specific quality of life assessment scale. Higher scores indicate better quality of life outcomes.

  14. Functional Assessment of Cancer Therapy-Breast [ Time Frame: 12-week assessment ]
    This is a disease specific quality of life assessment scale. Higher scores indicate better quality of life outcomes.

  15. Functional Assessment of Cancer Therapy-Breast [ Time Frame: 20-week assessment ]
    This is a disease specific quality of life assessment scale. Higher scores indicate better quality of life outcomes.

  16. Medical Outcomes Survey 36-item short form version [ Time Frame: 6-week assessment ]
    It measures quality of life with 36 items assessing eight health concepts, including bodily pain, role limitations and emotional well-being. Higher scores indicate worse quality of life outcomes.

  17. Medical Outcomes Survey 36-item short form version [ Time Frame: 12-week assessment ]
    It measures quality of life with 36 items assessing eight health concepts, including bodily pain, role limitations and emotional well-being. Higher scores indicate worse quality of life outcomes.

  18. Medical Outcomes Survey 36-item short form version [ Time Frame: 20-week assessment ]
    It measures quality of life with 36 items assessing eight health concepts, including bodily pain, role limitations and emotional well-being. Higher scores indicate worse quality of life outcomes.

  19. Brief Pain Inventory [ Time Frame: 12 weeks assessment ]
    Brief Pain Inventory (BPI) 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.

  20. Brief Pain Inventory [ Time Frame: 20 weeks assessment ]
    Brief Pain Inventory (BPI) 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.


Other Outcome Measures:
  1. Questionnaire for Patient Sociodemographic and Clinical Characteristics [ Time Frame: baseline assessment ]
    Sample characteristics obtained in a descriptive manner (i.e. sex; education level, stage of disease; duration of hormone treatment etc).



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03836872


Contacts
Contact: Alex Molassiotis, PhD 34008187 ext 34008187 alex.molasiotis@polyu.edu.hk
Contact: Xian-Liang LIU, PhD 34008187 ext 34008187 xianliang.d.liu@polyu.edu.hk

Sponsors and Collaborators
The Hong Kong Polytechnic University
The Affiliated Hospital Of Southwest Medical University
Investigators
Study Chair: Alex Molassiotis, PhD The Hong Kong Polytechnic University

Publications:
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.
Cleeland, C. S. (2014). The brief pain inventory user guide. 2009. Cleeland Charles S, Houston, TX Google Scholar.
Zhu, J., Zhang, Y., Pang, L., & Fu, H. (2006) Test of Reliability and Validity of Short-Form Arthritis Impact Measurement Scales2 (AIMS2-SF). Chinese Journal of Prevention and Control of Chronic Non- Communicable Diseases, 14: 7577.

Responsible Party: Professor Alex MOLASIOTIS, Chair Professor of Nursing and Head, The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier: NCT03836872     History of Changes
Other Study ID Numbers: HSEARS20180509004
First Posted: February 11, 2019    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases