Breast NeoplasmsPhase 2NCT04927910

Self-applied Acupressure for Arthralgia-fatigue-sleep Disturbance in Breast Cancer

A Phase 2 study testing Ture self-acupressure in people with Breast Neoplasms and Cancer Survivor, run by The Hong Kong Polytechnic University at 1 site in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 to 75 years, women only
Conditions the study is for: Breast Neoplasms, Cancer Survivor
What is being tested?: Ture self-acupressure
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 21 participants
Where: 1 siteChina
Study dates: 5 Jun 2021to 29 Mar 2022
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Female adult aged 18 and older;
Clinical diagnosis of early-stage (Stage I, II, or IIIa), hormone-receptor-positive breast cancer;
Completion of surgery, and/or chemotherapy and/or radiotherapy;
Currently taking the third generation of AIs (anastrozole, letrozole, or exemestane) for at least 1 month;
Based on their self-reports of moderate symptoms of joint pain and fatigue or sleep disturbance;
Willing to comply with the intervention protocol, and
Being able to communicate in Chinese .

Who cannot join

Previous receipt of acupuncture and acupressure within the past six months;
Currently receiving medications (unchanged for 3 month), physical therapy and other complementary and alternative medicines for the treatment of joint pain, fatigue and sleep disturbance;
Prior joint surgery or fracture during the past six months;
Mentally incapable of participating in the study (Hong Kong version of Montreal Cognitive Assessment score<22);and
Inability to perform self-care (Karnofsky Performance Scale score<70).

Trial locations and contacts

1 site in 1 country.

China1 site

The Huazhong University of Science and Technology Union Shenzhen Hospital
Shenzhen, Guangdong

Other trials in China

About this study

Official title: Self-applied Acupressure for Arthralgia-fatigue-sleep Disturbance Symptom Cluster in Breast Cancer Survivors Receiving Aromatase Inhibitors

This study aims to evaluate the feasibility, acceptability and preliminary effects of self-applied acupressure on arthralgia-fatigue-sleep disturbance symptom cluster in breast cancer survivors receiving aromatase inhibitors. This is a preliminary randomized controlled trial, with a three-arm trial design including verum self-acupressure, sham self-acupressure, and usual care. Subjects will include 52 breast cancer survivors who are receiving aromatase inhibitors and have experienced a moderate level of joint pain and at least one of the two symptoms including fatigue and sleep disturbance. Subjects who are randomized to either the verum self-acupressure group (group A) or the sham self-acupressure group (group B) will receive up to 8 weeks of the intervention consisting of two components: (1) two individual/group acupressure training sessions over 2 weeks and (2) self-acupressure for 6 weeks. The method and duration of self-acupressure in the sham group will be the same to those in the verum intervention group. The control group will receive usual care. The outcome measures of this study will be related to feasibility, acceptability and preliminary effects of self-acupressure. Individual in-depth interviews will be conducted with selected participants in group A and B to understand their perceptions and perceived effectiveness of the intervention.

Conditions: Breast Neoplasms, Cancer Survivor
Being tested: Ture self-acupressure, Sham self-acupressure, Usual care
Medical subject headings: Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ture self-acupressureOther
8-week intervention of self-acupressure on acupoints
Sham self-acupressureOther
8-week intervention of self-acupressure on non-acupoints
Usual careOther
routine care by hospitals

Study groups in NCT04927910
Study group	Role	What they receive
True self-acupressure	Experimental	1) two individual/group acupressure training sessions over 2 weeks and (2) self-acupressure for 6 weeks. Receives: Other: Ture self-acupressure
Sham self-acupressure	Sham comparator	Same protocol to the true self-acupressure group but on the sham acupoints Receives: Other: Sham self-acupressure
Usual care	Other	General advise on managing symptoms provided by healthcare providers Receives: Other: Usual care

What is being measured

The primary outcome is the main question the study is designed to answer.

Feasibility measure
Eligibility rate
Measured: Immediately after completion of the intervention (T1)
Feasibility measure
Recruitment rate
Measured: Immediately after completion of the intervention (T1)
Feasibility measure
Attrition rate
Measured: Immediately after completion of the intervention (T1)
Feasibility measure
Time to complete the recruitment
Measured: Immediately after completion of the intervention (T1)
Feasibility measure
Intervention adherence (using a patient-reported diary to document if the patient has completed the intervention daily, experienced any side effects, any other feelings or thoughts )
Measured: Immediately after completion of the intervention (T1)
Acceptability measure
Appropriateness of the intervention components using a self-developed questionnaire (15 close-ended questions mostly on a scale of 1 to 5, higher score indicating higher acceptability and 3 open-ended questions)
Measured: Immediately after completion of the intervention (T1)

Secondary outcomes (4)

Arthralgia
The Brief Pain Inventory- Short Form to assess joint pain related to aromatase inhibitor-induced arthralgia on a scale of 0=no pain, 10=extreme pain
Measured: Baseline(T0) and Immediately after completion of the intervention (T1)
Fatigue
The Brief Fatigue Inventory to measure fatigue on a scale of 0=no fatigue, 10=extreme fatigue
Measured: Baseline(T0) and Immediately after completion of the intervention (T1)
Sleep disturbance
The Pittsburgh Sleep Quality Index (PSQI) to measure sleep disturbance (with different item options) [a global score ranges from 0 to 21, with a higher score indicating poor sleep quality]
Measured: Baseline(T0) and Immediately after completion of the intervention (T1)
Health-related quality of life
The Functional Assessment of Cancer Therapy scale (FACT-G) to measure health-related quality of life on a scale of 0=lower health-related quality of life, 4=higher health-related quality of life
Measured: Baseline(T0) and Immediately after completion of the intervention (T1)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Jun 202129 Mar 2022

First posted16 Jun 2021
Study start5 Jun 2021
Primary completion29 Jan 2022
Study completion29 Mar 2022

Why it stopped: COVID 19 outbreak and manpower issues

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 21 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04927910
Sponsor's protocol ID: 01
Status last verified: Apr 2024
First submitted: 29 Mar 2021
Last updated: 26 Apr 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Breast Neoplasms trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Self-applied Acupressure for Arthralgia-fatigue-sleep Disturbance Symptom Cluster in Breast Cancer Survivors Receiving Aromatase Inhibitors
ClinicalTrials.gov ID: NCT04927910
Acronym / sponsor ID: 01
Conditions: Breast Neoplasms, Cancer Survivor
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: COVID 19 outbreak and manpower issues
Enrolment: 21 participants (actual)
Lead sponsor: The Hong Kong Polytechnic UniversityUniversity, hospital or other
Collaborators: Huazhong University of Science and Technology Union Shenzhen Hospital
Study start: 5 Jun 2021 (actual)
Primary completion: 29 Jan 2022 (actual)
Study completion: 29 Mar 2022 (actual)
First posted: 16 Jun 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 3

Arm	Type	Receives
True self-acupressure	Experimental	Other: Ture self-acupressure1) two individual/group acupressure training sessions over 2 weeks and (2) self-acupressure for 6 weeks.
Sham self-acupressure	Sham comparator	Other: Sham self-acupressureSame protocol to the true self-acupressure group but on the sham acupoints
Usual care	Other	Other: Usual careGeneral advise on managing symptoms provided by healthcare providers

Who may qualify

Ages: 18 to 75 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Female adult aged 18 and older;
Clinical diagnosis of early-stage (Stage I, II, or IIIa), hormone-receptor-positive breast cancer;
Completion of surgery, and/or chemotherapy and/or radiotherapy;
Currently taking the third generation of AIs (anastrozole, letrozole, or exemestane) for at least 1 month;
Based on their self-reports of moderate symptoms of joint pain and fatigue or sleep disturbance;

Key exclusion criteria (5 listed)

Previous receipt of acupuncture and acupressure within the past six months;
Currently receiving medications (unchanged for 3 month), physical therapy and other complementary and alternative medicines for the treatment of joint pain, fatigue and sleep disturbance;
Prior joint surgery or fracture during the past six months;
Mentally incapable of participating in the study (Hong Kong version of Montreal Cognitive Assessment score<22);and
Inability to perform self-care (Karnofsky Performance Scale score<70).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Ture self-acupressure8-week intervention of self-acupressure on acupoints	Other	True self-acupressure
Sham self-acupressure8-week intervention of self-acupressure on non-acupoints	Other	Sham self-acupressure
Usual careroutine care by hospitals	Other	Usual care

Primary outcome

Feasibility measure
Time frame: Immediately after completion of the intervention (T1)
Eligibility rate
Feasibility measure
Time frame: Immediately after completion of the intervention (T1)
Recruitment rate
Feasibility measure
Time frame: Immediately after completion of the intervention (T1)
Attrition rate
Feasibility measure
Time frame: Immediately after completion of the intervention (T1)
Time to complete the recruitment
Feasibility measure
Time frame: Immediately after completion of the intervention (T1)
Intervention adherence (using a patient-reported diary to document if the patient has completed the intervention daily, experienced any side effects, any other feelings or thoughts )
Acceptability measure
Time frame: Immediately after completion of the intervention (T1)
Appropriateness of the intervention components using a self-developed questionnaire (15 close-ended questions mostly on a scale of 1 to 5, higher score indicating higher acceptability and 3 open-ended questions)

4 secondary outcomes

Arthralgia
Time frame: Baseline(T0) and Immediately after completion of the intervention (T1)
Fatigue
Time frame: Baseline(T0) and Immediately after completion of the intervention (T1)
Sleep disturbance
Time frame: Baseline(T0) and Immediately after completion of the intervention (T1)
Health-related quality of life
Time frame: Baseline(T0) and Immediately after completion of the intervention (T1)

Results and safety

The study was stopped early (reason given: COVID 19 outbreak and manpower issues). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2024.
Individual participant dataSharing planned: No

Related trials for Breast Neoplasms

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Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Huilin Cheng, PhD principal investigator

The Hong Kong Polytechnic University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ture self-acupressure in people with Breast Neoplasms and Cancer Survivor, run by The Hong Kong Polytechnic University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 26 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: COVID 19 outbreak and manpower issues). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility measure (time frame: Immediately after completion of the intervention (T1)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04927910.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2024.