Breast NeoplasmsNCT06376357
The Effect of Foot Massage With Roles on Cancer Patients
A study testing Foot Massage with roller in people with Breast Neoplasms and Over Cancer, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial summary
It was aimed to examine the roles in the management of treatment-related peripheral neuropathy in cancer patients receiving taxane-based chemotherapy and the effect of foot massage on neuropathy and quality of life. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Breast Neoplasms, Over Cancer, Foot Massage
- What is being tested?
- Foot Massage with roller
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Apr 2024to 30 Jul 2024
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being registered in the medical oncology outpatient clinic of Selçuk University Faculty of Medicine Hospital
- Completed standard taxane-based chemotherapy treatment protocol for breast and ovarian cancer
- Karnofsky Performance Scale being 80 and above (Performance scale of cancer patients)
- Being 18 years or older
- Having received at least 3 cycles of taxane-based treatment
- Presence of grade 2 or higher peripheral neuropathy
- Being conscious and cooperative
- Verbal and written approval to participate in the study after an explanation about the study is made.
Who cannot join
- Previous skin sensitivity on hands and feet
- Refused to participate in the study after making a statement about the study
- Development of peripheral neuropathy due to reasons other than chemotherapy [tumor compression, nutritional disorders, infections or major systemic disease (diabetes mellitus, etc.)]
- Bone, spine metastasis or malignancy
- Having mental and psychic problems that would prevent him from taking part in the research.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Roles in the Management of Treatment-Induced Peripheral Neuropathy in Cancer Patients Receiving Taxane-Based Chemotherapy and the Effect of Foot Massage on Neuropathy and Quality of Life: A Randomized Controlled Study
It was aimed to examine the roles in the management of treatment-related peripheral neuropathy in cancer patients receiving taxane-based chemotherapy and the effect of foot massage on neuropathy and quality of life.
Read the detailed description
Intervention Phase of the Research;
- Patient information about neuropathy caused by chemotherapy and its management,
- Teaching the role application to the patient,
- Application process
- It will be carried out in 4 steps, including patient monitoring via telemonitoring.
- Conditions
- Breast Neoplasms, Over Cancer, Foot Massage
- Being tested
- Foot Massage with roller
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foot Massage with rollerOther
The intervention group is expected to apply roller massage to the soles of both feet in a sitting position on a chair (8 hours apart at 08.00, 16.00, 24.00 hours) every day for 6 weeks, 3x5 minutes a day. Video recording will be used as a reminder in the application.
| Study group | Role | What they receive |
|---|---|---|
| Study | Experimental | Not described Receives: Other: Foot Massage with roller |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
EORTC QLQ C-30 Quality of Life Scale
Quality of life of patients will be evaluated with EORTC QLQ-C30, which was developed by EORTC for cancer patients and is widely used all over the world.
Measured: 10 minutes
CIPN20 Neuropathy Scale
It is a 20-item assessment tool used to reveal the symptoms of chemotherapy-related peripheral neuropathy and the impact of functional limitations caused by this problem on patients' lives.
Measured: 10 minutes
One Leg Standing Test
The Single Leg Standing Test (TAUDT), which is widely used to evaluate static balance, is a simple test that can be used in many situations and requires minimal equipment.
Measured: 5 minutes
Brief Pain Inventory BPI
The BPI questionnaire is a short, easy-to-apply assessment method that can be used to evaluate pain and related functions (general activity, walking ability, normal work, relationships with other people, sleep, enjoyment of life). It includes simple 0 to 10 numerical rating scales that are both easy to understand and easy to translate into different languages. In the short pain inventory, the mildest pain score = 0 and the most severe pain score = 10.
Measured: 5 minutes
Pain Threshold Assessment Test
algometer (Baseline, USA) will be used. The Algometer (Relevant material is located in Selçuk University SHMYO application laboratory and it is planned to be taken and used with a report for the study and returned after the last measurements) is positioned upright and the pressure is increased to 1kg/cm2 at the painful point every three seconds and the measurements are taken with a 30-second rest period in between. It is applied 3 times and the average of 3 measurements is used for analysis.
Measured: 5 minutes
Two Point Discrimination
Evaluation will be made from the trans-metatarsal area, middle of the foot and middle of the heel. It will start from the interval where two points can be easily distinguished. The distance between two points will be reduced in 1 mm intervals until the two points are felt as a single point. Then, it will start with two-point stimulation at the minimum interval felt as a single point, and the distance between the two points will be increased in 1 mm intervals until the distance between the two points is felt separately as two points again.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2024
- Study start27 Apr 2024 (estimated)
- Primary completion15 Jun 2024 (estimated)
- Study completion30 Jul 2024 (estimated)
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 Selcuk 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ülkü Saygılı, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06376357
- Sponsor's protocol ID
- 16.04.24/1
- Status last verified
- Apr 2024
- First submitted
- 16 Apr 2024
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Roles in the Management of Treatment-Induced Peripheral Neuropathy in Cancer Patients Receiving Taxane-Based Chemotherapy and the Effect of Foot Massage on Neuropathy and Quality of Life: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06376357
- Acronym / sponsor ID
- 16.04.24/1
- Conditions
- Breast Neoplasms, Over Cancer, Foot Massage
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 27 Apr 2024 (estimated)
- Primary completion
- 15 Jun 2024 (estimated)
- Study completion
- 30 Jul 2024 (estimated)
- First posted
- 19 Apr 2024 (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.
It was aimed to examine the roles in the management of treatment-related peripheral neuropathy in cancer patients receiving taxane-based chemotherapy and the effect of foot massage on neuropathy and quality of life.
Detailed description
Intervention Phase of the Research;
- Patient information about neuropathy caused by chemotherapy and its management,
- Teaching the role application to the patient,
- Application process
- It will be carried out in 4 steps, including patient monitoring via telemonitoring.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study | Experimental | Other: Foot Massage with roller |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Being registered in the medical oncology outpatient clinic of Selçuk University Faculty of Medicine Hospital
- Completed standard taxane-based chemotherapy treatment protocol for breast and ovarian cancer
- Karnofsky Performance Scale being 80 and above (Performance scale of cancer patients)
- Being 18 years or older
- Having received at least 3 cycles of taxane-based treatment
Key exclusion criteria (5 listed)
- Previous skin sensitivity on hands and feet
- Refused to participate in the study after making a statement about the study
- Development of peripheral neuropathy due to reasons other than chemotherapy [tumor compression, nutritional disorders, infections or major systemic disease (diabetes mellitus, etc.)]
- Bone, spine metastasis or malignancy
- Having mental and psychic problems that would prevent him from taking part in the research.
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 |
|---|---|---|
| Foot Massage with rollerThe intervention group is expected to apply roller massage to the soles of both feet in a sitting position on a chair (8 hours apart at 08.00, 16.00, 24.00 hours) every day for 6 weeks, 3x5 minutes a day. Video recording will be used as a reminder in the application. | Other | Study |
Primary outcome
EORTC QLQ C-30 Quality of Life Scale
Time frame: 10 minutes
Quality of life of patients will be evaluated with EORTC QLQ-C30, which was developed by EORTC for cancer patients and is widely used all over the world.
CIPN20 Neuropathy Scale
Time frame: 10 minutes
It is a 20-item assessment tool used to reveal the symptoms of chemotherapy-related peripheral neuropathy and the impact of functional limitations caused by this problem on patients' lives.
One Leg Standing Test
Time frame: 5 minutes
The Single Leg Standing Test (TAUDT), which is widely used to evaluate static balance, is a simple test that can be used in many situations and requires minimal equipment.
Brief Pain Inventory BPI
Time frame: 5 minutes
The BPI questionnaire is a short, easy-to-apply assessment method that can be used to evaluate pain and related functions (general activity, walking ability, normal work, relationships with other people, sleep, enjoyment of life). It includes simple 0 to 10 numerical rating scales that are both easy to understand and easy to translate into different languages. In the short pain inventory, the mildest pain score = 0 and the most severe pain score = 10.
Pain Threshold Assessment Test
Time frame: 5 minutes
algometer (Baseline, USA) will be used. The Algometer (Relevant material is located in Selçuk University SHMYO application laboratory and it is planned to be taken and used with a report for the study and returned after the last measurements) is positioned upright and the pressure is increased to 1kg/cm2 at the painful point every three seconds and the measurements are taken with a 30-second rest period in between. It is applied 3 times and the average of 3 measurements is used for analysis.
Two Point Discrimination
Time frame: 10 minutes
Evaluation will be made from the trans-metatarsal area, middle of the foot and middle of the heel. It will start from the interval where two points can be easily distinguished. The distance between two points will be reduced in 1 mm intervals until the two points are felt as a single point. Then, it will start with two-point stimulation at the minimum interval felt as a single point, and the distance between the two points will be increased in 1 mm intervals until the distance between the two points is felt separately as two points again.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Foot Massage with roller in people with Breast Neoplasms and Over Cancer, run by Selcuk University at 1 site in Turkey (Türkiye).
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 8 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 19 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 Turkey (Türkiye). 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?
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?
EORTC QLQ C-30 Quality of Life Scale (time frame: 10 minutes). 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?
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 19 Apr 2024.