Cancer, BreastNCT05409352
Self-administered Acupressure to Improve Cancer-related Fatigue Among Cancer Patients Undergoing Chemotherapy
A study testing Self-administered acupressure and Aerobic exercise in people with Cancer, Breast and Fatigue, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
The primary aim of the study is to determine whether self-administered acupressure has effects equivalent to aerobic exercise on CRF in cancer patients undergoing chemotherapy. Secondary outcomes include sleep disturbance (self-reported and objective), activity levels (self-reported and objective), quality of life… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Breast, Fatigue, Acupressure
- What is being tested?
- Self-administered acupressure and Aerobic exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jun 2022to May 2025
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged 18 or above
- with a diagnosis of breast cancer
- scheduled to commence their first cycle of outpatient adjuvant chemotherapy
- have an Eastern Cooperative Oncology Group performance status of 0 or 1
- screened as no contraindications for exercise based on a pre-exercise safety assessment (including aspects of blood results, cardiorespiratory signs and symptoms, metastasis, and variations in cognitive functions)
- written informed consent
Who cannot join
- have received/self-administered acupressure or acupuncture in the previous 3 months
- have engaged in >90 min of moderate intensity aerobic exercise per week in the previous 3 months
- are pregnant or lactating
- have any injury or ulcers around the acupoints
- unable to communicate in Cantonese, Mandarin, or English
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Queen Mary Hospital
Hong Kong
Denise Shuk Ting Cheung, PhD, 39176673, denisest@hku.hk
About this study
Official title: Effects of Self-administered Acupressure Versus Aerobic Exercise for Treating Cancer-related Fatigue in Cancer Patients Undergoing Chemotherapy: A Randomized Controlled Equivalence Trial
The primary aim of the study is to determine whether self-administered acupressure has effects equivalent to aerobic exercise on CRF in cancer patients undergoing chemotherapy. Secondary outcomes include sleep disturbance (self-reported and objective), activity levels (self-reported and objective), quality of life (QoL), cognitive impairment, return to work, chemotherapy completion, and adherence to the intervention. This will be a prospective, assessor-blind, parallel group randomized controlled trial (RCT) that will strictly follow the CONSORT guidelines. A total of 138 patients aged 18 or above with a diagnosis of breast cancer scheduled to commence their first cycle of outpatient adjuvant chemotherapy will be recruited and randomized into self-administered acupressure and aerobic exercise groups. The hypothesis of this study is self-administered acupressure and aerobic exercise demonstrate equivalent effects on CRF. The acupressure arm comprises of a one-on-one, 90-min instructional session and a 1-hour follow-up visit by a trained Traditional Chinese Medicine (TCM) practitioner, and self-practice for 12 weeks. The exercise arm consists of a one-on-one, 90-min instructional session and a 1-hour follow-up visit by a trained exercise specialist, and self-practice for 12 weeks. Participants will be instructed to maintain self-practice after the intervention. Intention-to-treat analysis will be performed.
Read the detailed description
Cancer-related fatigue (CRF) is recognized as the most frequently reported and distressing symptom among cancer patients. CRF is particularly prevalent in patients undergoing chemotherapy, reported to affect 82-100% of such patients, which in some cases may lead to treatment interruption or discontinuation. If CRF is left untreated during chemotherapy, patients are more likely to have clinically significant CRF that persists for months and years after the treatment. CRF has pervasive impact on a patient's mood, ability to perform daily activities, social relationships, and quality of life (QoL). It also imposes significant financial burden by limiting a patient's ability to work. CRF has been shown to be a risk factor of cancer recurrence and shortened survival. In view of its high prevalence and negative impact, combined with growing survival rates, CRF can be considered as a major public health concern.
Aerobic exercise is the most recommended non-pharmacological strategy for CRF, but it has practical limitations due to a number of barriers to exercise during cancer treatment. Self-administered acupressure is emerging as a promising new strategy for reducing CRF in post-treatment disease-free cancer survivors, but has not been tested rigorously among cancer patients receiving chemotherapy. Both exercise and acupressure are inexpensive and safe self-management strategies that can alleviate CRF and co-occurring cancer symptoms, but as acupressure demands less energy, it may thus be acceptable for a wider range of patients undergoing chemotherapy and experiencing CRF. While previous RCTs on acupressure have focused on post-treatment cancer patients, studies targeting patients undergoing cancer treatment are scarce. A rigorously designed RCT of self-administered acupressure among patients receiving chemotherapy is warranted. To date, no study has examined the equivalence of self-administered acupressure and exercise for reducing CRF. Knowledge of the equivalence of aerobic exercise and acupressure for relieving CRF has important clinical implications that could allow practitioners to target recommendations on the basis of patient preference for a particular type of self-care management.
The primary aim of this study is to determine whether self-administered acupressure has effects equivalent to aerobic exercise on CRF in cancer patients undergoing chemotherapy. The hypothesis of this study is self-administered acupressure and aerobic exercise demonstrate equivalent effects on CRF. Secondary outcomes include sleep disturbance (self-reported and objective), activity levels (self-reported and objective), QoL, cognitive impairment, return to work, chemotherapy completion, and adherence to the intervention.
- Conditions
- Cancer, Breast, Fatigue, Acupressure, Exercise
- Being tested
- Self-administered acupressure, Aerobic exercise
- Keywords
- cancer, fatigue, acupressure, exercise, chemotherapy
- Medical subject headings
- Breast Neoplasms, Fatigue, Motor Activity, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-administered acupressureBehavioural
Participants will receive training of self-acupressure on the 5 standard acupoints by a trained traditional Chinese medicine (TCM) practitioner, have return-demonstration, be assessed by the practitioner with the use of a competency checklist, and be instructed to perform self-acupressure on the standard acupoints once a day. A follow-up visit will be conducted to reinforce learning, in which participants will demonstrate the acupressure technique while the practitioner observes and provides feedback, including suggestions for technique adjustments if necessary. The practitioner will recommend 2 additional acupoints from the list of optional acupoints based on the patients' sensitivity to acupoint stimulation and preference. Daily duration of self-practice will range from 8-10 minutes depending on the semi-individualized protocol (5 standard + 2 optional acupoints).
Aerobic exerciseBehavioural
Participants will receive verbal and written information from a trained exercise specialist about the specific advice of the desired exercise frequency (3x/week), duration (30 min each time), and intensity (moderate determined by rating of 12 to 14 on the Borg Rating of Perceived Exertion scale). The exercise specialist will demonstrate how to perform walking at moderate intensity indoors and outdoors, followed by return-demonstration of the patient. Education on safety precautions and walk schedule planning will be provided. Competency check will be performed to assess participants' ability to self-monitor and self-regular exercise intensity using Borg Scale. One week after the start of the program, the exercise specialist will conduct a 1-hour follow-up visit to supervise the patient's walking session and assess whether there is any additional advice needed.
| Study group | Role | What they receive |
|---|---|---|
| Self-administered acupressure | Experimental | The entire intervention will last 12 weeks, including a one-on-one, 90-min instructional session at week 1 and a one-hour follow-up visit at week 2, which are conducted by a trained traditional Chinese medicine practitioner. Participants will be instructed to perform self-acupressure on the acupoints according to individualized protocol once a day. Participants will be instructed to maintain self-practice after the intervention. Receives: Behavioral: Self-administered acupressure |
| Aerobic exercise | Active comparator | The 12-week aerobic exercise program consists of a one-on-one, 90-min instructional session at week 1 and a one-hour follow-up visit at week 2, which are conducted by a trained exercise specialist. Participants will be advised to perform aerobic exercise of moderate intensity 3 times per week for 30 minutes each time. Accumulating 90 min of exercise per week through more frequent short bouts (e.g. 10-20 min daily) are allowed during the first week of each chemotherapy cycle due to increased symptom burden. Participants will be instructed to maintain self-practice after the intervention. Receives: Behavioral: Aerobic exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue levels
The Brief Fatigue Inventory (BFI, 9 items) will be used to assess fatigue levels. The first 3 items (fatigue severity subscale) ask patients to describe their current, usual, and worst fatigue in the past 24 hours. The next 6 items (interference subscale) ask the extent to which fatigue interferes with various aspects of life. The mean scores of the 9 items can be categorized as mild (1-3), moderate (4-6), and severe (7-10).
Measured: post-intervention (the week after the 12-week intervention)
Fatigue levels
The Brief Fatigue Inventory (BFI, 9 items) will be used to assess fatigue levels. The first 3 items (fatigue severity subscale) ask patients to describe their current, usual, and worst fatigue in the past 24 hours. The next 6 items (interference subscale) ask the extent to which fatigue interferes with various aspects of life. The mean scores of the 9 items can be categorized as mild (1-3), moderate (4-6), and severe (7-10).
Measured: one month after the end of all chemotherapy cycles
Secondary outcomes (8)
Self-reported sleep quality
The Pittsburgh Sleep Quality Index (PSQI, 19 items) will be used to assess self-reported sleep quality. Seven component scores are formed: sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The scores are summed to produce a global score (0 to 21), with higher scores denoting poorer sleep quality.
Measured: post-intervention (the week after the 12-week intervention), one month after the end of all chemotherapy cycles
Health-related quality of life (QoL)
The Functional Assessment of Cancer Therapy-Breast (FACT-B) will be used to assess health-related QoL. It has 5 domains: physical, emotional, social/family, and functional well-being. The higher the total scores, the higher levels of QoL.
Measured: post-intervention (the week after the 12-week intervention), one month after the end of all chemotherapy cycles
Self-reported activity levels
Self-reported activity levels will be measured by the 7-item International Physical Activity Questionnaire short form (IPAQ-SF). Participants will recall types of intensity of physical activity (for estimating total physical activity in metabolic equivalent task-min/week) and sitting time in the last 7 days.
Measured: post-intervention (the week after the 12-week intervention), one month after the end of all chemotherapy cycles
Return to work
Return to work will be calculated as the percentage of work resumption among those in paid employment at the time of diagnosis and absent from work before the start of treatment.
Measured: one month after the end of all chemotherapy cycles
Chemotherapy completion
Chemotherapy completion will be calculated as the percentage of patients who would complete chemotherapy without dose adjustments.
Measured: one month after the end of all chemotherapy cycles
Objective measure of sleep quality and activity levels
Actigraphy will serve as an objective measure of sleep quality and activity levels. The ActiGraph, a non-invasive, wristwatch-sized device, is a widely used, valid, and reliable measure of activity and sleep. Patients will be asked to wear it for three separate 72-hour periods at study entry, post-intervention, one month after the end of all chemotherapy cycles. The parameters of the activity-rest and sleep-wake patterns (e.g., step count, total sleep time, sleep efficiency) will be analyzed by the accompanying software. Participants will record daily activities, bedtimes, and rising times when wearing the device in the diary.
Measured: post-intervention (the week after the 12-week intervention), one month after the end of all chemotherapy cycles
Adherence
Adherence from study entry to post-intervention and from post-intervention to one month after the end of all chemotherapy cycles will be calculated based on the exercise/acupressure diary. Those who have completed ≥ 75% of prescription will be regarded as adherers.
Measured: post-intervention (the week after the 12-week intervention), one month after the end of all chemotherapy cycles
Cognitive impairment
Cognitive impairment will be assessed using the Montreal Cognitive Assessment (MoCA) 5-min and the cognitive functioning subscale of European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30).
Measured: post-intervention (the week after the 12-week intervention), one month after the end of all chemotherapy cycles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2022
- Study start1 Jun 2022
- Primary completionMay 2025 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer, BreastStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cheung Shuk-Ting, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05409352
- Sponsor's protocol ID
- UW21084
- Status last verified
- Nov 2023
- First submitted
- 30 May 2022
- Last updated
- 28 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be available on reasonable request as decided by the principal investigator.
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Self-administered Acupressure Versus Aerobic Exercise for Treating Cancer-related Fatigue in Cancer Patients Undergoing Chemotherapy: A Randomized Controlled Equivalence Trial
- ClinicalTrials.gov ID
- NCT05409352
- Acronym / sponsor ID
- UW21084
- Conditions
- Cancer, Breast, Fatigue, Acupressure, Exercise
- Keywords
- cancer, fatigue, acupressure, exercise, chemotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 8 Jun 2022 (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.
The primary aim of the study is to determine whether self-administered acupressure has effects equivalent to aerobic exercise on CRF in cancer patients undergoing chemotherapy. Secondary outcomes include sleep disturbance (self-reported and objective), activity levels (self-reported and objective), quality of life (QoL), cognitive impairment, return to work, chemotherapy completion, and adherence to the intervention. This will be a prospective, assessor-blind, parallel group randomized controlled trial (RCT) that will strictly follow the CONSORT guidelines. A total of 138 patients aged 18 or above with a diagnosis of breast cancer scheduled to commence their first cycle of outpatient adjuvant chemotherapy will be recruited and randomized into self-administered acupressure and aerobic exercise groups. The hypothesis of this study is self-administered acupressure and aerobic exercise demonstrate equivalent effects on CRF. The acupressure arm comprises of a one-on-one, 90-min instructional session and a 1-hour follow-up visit by a trained Traditional Chinese Medicine (TCM) practitioner, and self-practice for 12 weeks. The exercise arm consists of a one-on-one, 90-min instructional session and a 1-hour follow-up visit by a trained exercise specialist, and self-practice for 12 weeks. Participants will be instructed to maintain self-practice after the intervention. Intention-to-treat analysis will be performed.
Detailed description
Cancer-related fatigue (CRF) is recognized as the most frequently reported and distressing symptom among cancer patients. CRF is particularly prevalent in patients undergoing chemotherapy, reported to affect 82-100% of such patients, which in some cases may lead to treatment interruption or discontinuation. If CRF is left untreated during chemotherapy, patients are more likely to have clinically significant CRF that persists for months and years after the treatment. CRF has pervasive impact on a patient's mood, ability to perform daily activities, social relationships, and quality of life (QoL). It also imposes significant financial burden by limiting a patient's ability to work. CRF has been shown to be a risk factor of cancer recurrence and shortened survival. In view of its high prevalence and negative impact, combined with growing survival rates, CRF can be considered as a major public health concern.
Aerobic exercise is the most recommended non-pharmacological strategy for CRF, but it has practical limitations due to a number of barriers to exercise during cancer treatment. Self-administered acupressure is emerging as a promising new strategy for reducing CRF in post-treatment disease-free cancer survivors, but has not been tested rigorously among cancer patients receiving chemotherapy. Both exercise and acupressure are inexpensive and safe self-management strategies that can alleviate CRF and co-occurring cancer symptoms, but as acupressure demands less energy, it may thus be acceptable for a wider range of patients undergoing chemotherapy and experiencing CRF. While previous RCTs on acupressure have focused on post-treatment cancer patients, studies targeting patients undergoing cancer treatment are scarce. A rigorously designed RCT of self-administered acupressure among patients receiving chemotherapy is warranted. To date, no study has examined the equivalence of self-administered acupressure and exercise for reducing CRF. Knowledge of the equivalence of aerobic exercise and acupressure for relieving CRF has important clinical implications that could allow practitioners to target recommendations on the basis of patient preference for a particular type of self-care management.
The primary aim of this study is to determine whether self-administered acupressure has effects equivalent to aerobic exercise on CRF in cancer patients undergoing chemotherapy. The hypothesis of this study is self-administered acupressure and aerobic exercise demonstrate equivalent effects on CRF. Secondary outcomes include sleep disturbance (self-reported and objective), activity levels (self-reported and objective), QoL, cognitive impairment, return to work, chemotherapy completion, and adherence to the intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-administered acupressure | Experimental | Behavioral: Self-administered acupressureThe entire intervention will last 12 weeks, including a one-on-one, 90-min instructional session at week 1 and a one-hour follow-up visit at week 2, which are conducted by a trained traditional Chinese medicine practitioner. Participants will be instructed to perform self-acupressure on the acupoints according to individualized protocol once a day. Participants will be instructed to maintain self-practice after the intervention. |
| Aerobic exercise | Active comparator | Behavioral: Aerobic exerciseThe 12-week aerobic exercise program consists of a one-on-one, 90-min instructional session at week 1 and a one-hour follow-up visit at week 2, which are conducted by a trained exercise specialist. Participants will be advised to perform aerobic exercise of moderate intensity 3 times per week for 30 minutes each time. Accumulating 90 min of exercise per week through more frequent short bouts (e.g. 10-20 min daily) are allowed during the first week of each chemotherapy cycle due to increased symptom burden. Participants will be instructed to maintain self-practice after the intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- aged 18 or above
- with a diagnosis of breast cancer
- scheduled to commence their first cycle of outpatient adjuvant chemotherapy
- have an Eastern Cooperative Oncology Group performance status of 0 or 1
- screened as no contraindications for exercise based on a pre-exercise safety assessment (including aspects of blood results, cardiorespiratory signs and symptoms, metastasis, and variations in cognitive functions)
Key exclusion criteria (5 listed)
- have received/self-administered acupressure or acupuncture in the previous 3 months
- have engaged in >90 min of moderate intensity aerobic exercise per week in the previous 3 months
- are pregnant or lactating
- have any injury or ulcers around the acupoints
- unable to communicate in Cantonese, Mandarin, or English
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 |
|---|---|---|
| Self-administered acupressureParticipants will receive training of self-acupressure on the 5 standard acupoints by a trained traditional Chinese medicine (TCM) practitioner, have return-demonstration, be assessed by the practitioner with the use of a competency checklist, and be instructed to perform self-acupressure on the standard acupoints once a day. A follow-up visit will be conducted to reinforce learning, in which participants will demonstrate the acupressure technique while the practitioner observes and provides feedback, including suggestions for technique adjustments if necessary. The practitioner will recommend 2 additional acupoints from the list of optional acupoints based on the patients' sensitivity to acupoint stimulation and preference. Daily duration of self-practice will range from 8-10 minutes depending on the semi-individualized protocol (5 standard + 2 optional acupoints). | Behavioural | Self-administered acupressure |
| Aerobic exerciseParticipants will receive verbal and written information from a trained exercise specialist about the specific advice of the desired exercise frequency (3x/week), duration (30 min each time), and intensity (moderate determined by rating of 12 to 14 on the Borg Rating of Perceived Exertion scale). The exercise specialist will demonstrate how to perform walking at moderate intensity indoors and outdoors, followed by return-demonstration of the patient. Education on safety precautions and walk schedule planning will be provided. Competency check will be performed to assess participants' ability to self-monitor and self-regular exercise intensity using Borg Scale. One week after the start of the program, the exercise specialist will conduct a 1-hour follow-up visit to supervise the patient's walking session and assess whether there is any additional advice needed. | Behavioural | Aerobic exercise |
Primary outcome
Fatigue levels
Time frame: post-intervention (the week after the 12-week intervention)
The Brief Fatigue Inventory (BFI, 9 items) will be used to assess fatigue levels. The first 3 items (fatigue severity subscale) ask patients to describe their current, usual, and worst fatigue in the past 24 hours. The next 6 items (interference subscale) ask the extent to which fatigue interferes with various aspects of life. The mean scores of the 9 items can be categorized as mild (1-3), moderate (4-6), and severe (7-10).
Fatigue levels
Time frame: one month after the end of all chemotherapy cycles
The Brief Fatigue Inventory (BFI, 9 items) will be used to assess fatigue levels. The first 3 items (fatigue severity subscale) ask patients to describe their current, usual, and worst fatigue in the past 24 hours. The next 6 items (interference subscale) ask the extent to which fatigue interferes with various aspects of life. The mean scores of the 9 items can be categorized as mild (1-3), moderate (4-6), and severe (7-10).
8 secondary outcomes
Self-reported sleep quality
Time frame: post-intervention (the week after the 12-week intervention), one month after the end of all chemotherapy cycles
Health-related quality of life (QoL)
Time frame: post-intervention (the week after the 12-week intervention), one month after the end of all chemotherapy cycles
Self-reported activity levels
Time frame: post-intervention (the week after the 12-week intervention), one month after the end of all chemotherapy cycles
Return to work
Time frame: one month after the end of all chemotherapy cycles
Chemotherapy completion
Time frame: one month after the end of all chemotherapy cycles
Objective measure of sleep quality and activity levels
Time frame: post-intervention (the week after the 12-week intervention), one month after the end of all chemotherapy cycles
Adherence
Time frame: post-intervention (the week after the 12-week intervention), one month after the end of all chemotherapy cycles
Cognitive impairment
Time frame: post-intervention (the week after the 12-week intervention), one month after the end of all chemotherapy cycles
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
- Individual participant dataSharing planned: Yes. Data will be available on reasonable request as decided by the principal investigator.
Related trials for Cancer, Breast
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-administered acupressure and Aerobic exercise in people with Cancer, Breast and Fatigue, run by The University of Hong Kong at 1 site in Hong Kong.
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 6 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: status not confirmed, as of the sponsor's last update on 28 Nov 2023. 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 Hong Kong. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Denise Shuk Ting Cheung, PhD (39176673, denisest@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue levels (time frame: post-intervention (the week after the 12-week intervention)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Nov 2023.