Breast NeoplasmsNCT02825810
Cervical Motor Control in Long-term Breast Cancer Survivors
A study of Breast Neoplasms, run by Universidad de Granada at 1 site in Spain.
Trial summary
The aim of this study will be to determine the effectiveness of a physical therapy program which is based on cervical motor control exercises in long-term breast cancer survivors in order to improve their motor control and its possible impact on pain, mood state and quality of life. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Neoplasms
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2016to May 2022
- 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 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To be over 18 years old
- Have passed a period equal o more 5 years since breast cancer diagnosis
- Have diagnosis of stage I, II or IIIA breast cancer
- Have signed informed consent
- Have medical clearance for participation
- Inability to get level 2 in the craniocervical flexion test
Who cannot join
- Have diagnosis of arthritis or fibromyalgia
- Have cancer recurrence
- Have been operated through previous surgery of cervical column
- To be taking any treatment for pain or altered motor control during last 12 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of a Physical Therapy Program for Improving Cervical Motor Control in Long-term Breast Cancer Survivors
The aim of this study will be to determine the effectiveness of a physical therapy program which is based on cervical motor control exercises in long-term breast cancer survivors in order to improve their motor control and its possible impact on pain, mood state and quality of life.
Read the detailed description
Background: Breast cancer is becoming a common disease; however survival rates have improved throughout the last years. As a result, this also means that breast cancer survivors suffer side effects concerning the disease itself and treatments, as it is the case of certain kinds of pain. It is known that 80% of breast cancer survivors suffer this even 5 years after the completion of treatment and this impairment can be associated with a high tendency towards depression, cardiorespiratory deconditioning and even altered cervical control motor.
Aim: To determine the effectiveness of a physical therapy program based on cervical motor control training in order to improve motor control, mood state and quality of life.
Methods: Fifty-two long-term breast cancer survivors will be allocated to experimental group (n=26) or control group (n=26). The experimental group will receive a nine-week tailored exercise training focused on cervical motor control.
Discussion: There is a lack of knowledge about effective interventions when it comes to deal with altered motor control pattern of cervical area in long-term breast cancer survivors. Therefore, it is necessary to study the impact of this novel approach to improve quality of life in this population.
- Conditions
- Breast Neoplasms
- Being tested
- Cervical motor control
- Keywords
- breast cancer, long-term survival, motor control, cervical pain
- Medical subject headings
- Breast Neoplasms, Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervical motor controlBehavioural
Intervention will consist in a tailored exercise training following a previous published motor control protocol
| Study group | Role | What they receive |
|---|---|---|
| Cervical motor control group | Experimental | Not described Receives: Behavioral: Cervical motor control |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neck Disability Index (NDI)
It is self-administered questionnaire to test neck pain interference in daily activities. It contains 10 items
Measured: Participants will be followed over 9 weeks
Secondary outcomes (8)
Craniocervical Flexion Test (CCFT)
It is used to assess deficit of cervical motor pattern
Measured: Participants will be followed over 9 weeks
Algometry
Pressure pain thresholds (PPTs) will be assessed using an electronic algometer (Somedic AB, Farsta, Sweden)
Measured: Participants will be followed over 9 weeks
Visual Analogue Scale (VAS)
It is used to assess subjective pain. It contains scores in the range of 0 to 10 (0 = 'no pain'; 10 = 'worst imaginable pain'). Participants will have to mark the level of pain that they feel in that moment for neck-shoulders areas
Measured: Participants will be followed over 9 weeks
Scale for Mood Assessment
It is used to assess 4 moods: anxiety, anger-hostility, sadness-depression, and happiness. It contains 16 items
Measured: Participants will be followed over 9 weeks
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) version 3.0
It is used to asses quality of life. It contains 30 items with both multi-item scales and single-item measures
Measured: Participants will be followed over 9 weeks
European Organization for Research and Treatment of Cancer Breast Cancer-Specific Quality of Life Questionnaire (EORTC QLQ-BR23)
It is a breast cancer module of EORTC QLQ-C30. This module contains 23 items assessing disease symptoms, side effects of treatment, body image, sexual functioning, and future perspective
Measured: Participants will be followed over 9 weeks
Minnesota Leisure Time Physical Activity Questionnaire (MLTPAQ)
It is used to calculate energy expenditure for leisure time physical activity
Measured: Participants will be followed over 9 weeks
International Fitness Scale (IFIS)
It is used to assess perceived patients' overall fitness, cardio-respiratory fitness, muscular fitness, speed-agility and flexibility
Measured: Participants will be followed over 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2016 (estimated)
- Study startOct 2016
- Primary completionMay 2022 (estimated)
- Study completionMay 2022 (estimated)
Why it stopped: No funding issues, poor prevalence of low cervical motor control
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.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Irene Cantarero Villanueva, Universidad de Granada
- Investigators
- Irene Cantarero-Villanueva, PhD, Principal investigator, Physical Therapy Deparment, Faculty of Health Sciences, University of Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02825810
- Sponsor's protocol ID
- UGR0116
- Status last verified
- Nov 2025
- First submitted
- 4 Jul 2016
- Last updated
- 18 Nov 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Physical Therapy Program for Improving Cervical Motor Control in Long-term Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT02825810
- Acronym / sponsor ID
- UGR0116
- Conditions
- Breast Neoplasms
- Keywords
- breast cancer, long-term survival, motor control, cervical pain
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No funding issues, poor prevalence of low cervical motor control
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- May 2022 (estimated)
- Study completion
- May 2022 (estimated)
- First posted
- 7 Jul 2016 (estimated)
- 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 aim of this study will be to determine the effectiveness of a physical therapy program which is based on cervical motor control exercises in long-term breast cancer survivors in order to improve their motor control and its possible impact on pain, mood state and quality of life.
Detailed description
Background: Breast cancer is becoming a common disease; however survival rates have improved throughout the last years. As a result, this also means that breast cancer survivors suffer side effects concerning the disease itself and treatments, as it is the case of certain kinds of pain. It is known that 80% of breast cancer survivors suffer this even 5 years after the completion of treatment and this impairment can be associated with a high tendency towards depression, cardiorespiratory deconditioning and even altered cervical control motor.
Aim: To determine the effectiveness of a physical therapy program based on cervical motor control training in order to improve motor control, mood state and quality of life.
Methods: Fifty-two long-term breast cancer survivors will be allocated to experimental group (n=26) or control group (n=26). The experimental group will receive a nine-week tailored exercise training focused on cervical motor control.
Discussion: There is a lack of knowledge about effective interventions when it comes to deal with altered motor control pattern of cervical area in long-term breast cancer survivors. Therefore, it is necessary to study the impact of this novel approach to improve quality of life in this population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cervical motor control group | Experimental | Behavioral: Cervical motor control |
| Control group | No intervention | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- To be over 18 years old
- Have passed a period equal o more 5 years since breast cancer diagnosis
- Have diagnosis of stage I, II or IIIA breast cancer
- Have signed informed consent
- Have medical clearance for participation
Key exclusion criteria (4 listed)
- Have diagnosis of arthritis or fibromyalgia
- Have cancer recurrence
- Have been operated through previous surgery of cervical column
- To be taking any treatment for pain or altered motor control during last 12 months
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 |
|---|---|---|
| Cervical motor controlIntervention will consist in a tailored exercise training following a previous published motor control protocol | Behavioural | Cervical motor control group |
Primary outcome
Neck Disability Index (NDI)
Time frame: Participants will be followed over 9 weeks
It is self-administered questionnaire to test neck pain interference in daily activities. It contains 10 items
8 secondary outcomes
Craniocervical Flexion Test (CCFT)
Time frame: Participants will be followed over 9 weeks
Algometry
Time frame: Participants will be followed over 9 weeks
Visual Analogue Scale (VAS)
Time frame: Participants will be followed over 9 weeks
Scale for Mood Assessment
Time frame: Participants will be followed over 9 weeks
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) version 3.0
Time frame: Participants will be followed over 9 weeks
European Organization for Research and Treatment of Cancer Breast Cancer-Specific Quality of Life Questionnaire (EORTC QLQ-BR23)
Time frame: Participants will be followed over 9 weeks
Minnesota Leisure Time Physical Activity Questionnaire (MLTPAQ)
Time frame: Participants will be followed over 9 weeks
International Fitness Scale (IFIS)
Time frame: Participants will be followed over 9 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
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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.
Irene Cantarero-Villanueva, PhD principal investigator
Physical Therapy Deparment, Faculty of Health Sciences, University of Granada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Breast Neoplasms, run by Universidad de Granada at 1 site in Spain.
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 4 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: withdrawn, as of the sponsor's last update on 18 Nov 2025. 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 Spain. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Neck Disability Index (NDI) (time frame: Participants will be followed over 9 weeks). 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 18 Nov 2025.