Cancer PainNCT06432998
Perineal Massage in Women With Gynecological Cancer
A study testing Perineal massage and Standard treatment in people with Cancer Pain and Neck Cancer, run by University of Alcala at 1 site in Spain.
Trial summary
The high incidence of gynecological cancers, together with dyspareunia and vaginal stenosis, some of its most frequent sequelae, create the need to continue studying and researching oncological physiotherapy techniques that treat and prevent these sequelae, in order to preserve and/or improve the quality of life of… Read more about this study
- Who is it for?
- Ages 18 to 52 years, women only
- Conditions the study is for
- Cancer Pain, Neck Cancer
- What is being tested?
- Perineal massage and Standard treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteSpain
- Study dates
- 31 May 2024to 20 Dec 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 to 52 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women between 18 and 52 years old
- Oncology patients with a diagnosis of dyspareunia and vaginal stenosis related to treatments.
- Patients with QT/RT/BT treatment who have a diagnosis of dyspareunia and vaginal stenosis.
- Patients on hormonal suppressive treatment with a diagnosis of dyspareunia and vaginal stenosis.
Who cannot join
- Patients who do not accept intracavitary treatment.
- Patients with abdominopelvic surgical treatment prior to oncological process.
- Patients with a diagnosis of dyspareunia prior to cancer.
- Patients with vaginal narrowing prior to cancer.
- Patients with menopause at the time of cancer diagnosis
Trial locations and contacts
1 site in 1 country.
Spain1 site
Asociación Española Contra el Cáncer en la provincia de Santa cruz de Tenerife.
Santa Cruz de Tenerife, Tenerife
About this study
Official title: Oncological Perineal Massage in Vaginal Stenosis and Dyspareunia in Women With Gynecological Cancer
The high incidence of gynecological cancers, together with dyspareunia and vaginal stenosis, some of its most frequent sequelae, create the need to continue studying and researching oncological physiotherapy techniques that treat and prevent these sequelae, in order to preserve and/or improve the quality of life of cancer patients. Therefore, through this study, we sought to verify the effectiveness of oncological perineal massage to treat pain during sexual intercourse and vaginal stenosis.
The objective of this study will be to demonstrate the effectiveness of a treatment that will consist of a health education session related to the pelvic floor and the consequences related to cancer along with ten sessions of oncological perineal massage that will be carried out for fifty minutes, once a week.
- Conditions
- Cancer Pain, Neck Cancer
- Being tested
- Perineal massage, Standard treatment
- Medical subject headings
- Cancer Pain, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perineal massageOther
The technique will be applied for approximately twenty minutes and will be carried out as follows: the vaginal dilator is introduced progressively using crescent-shaped movements. Once the dilator is fully inserted, movements will be made from bottom to top and from one side to the other, and then continue with the crescent-shaped movements.
Standard treatmentOther
The treatment will consist of the use of vaginal dilators according to the gold standard proposed in the literature. It will consist of introducing the same dilators as for the experimental group, with the same time schedule, but without massage, only introducing the dilator and keeping it in the vagina for 20 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Perineal massage | Experimental | Ten sessions of perineal massage, which will be carried out for fifty minutes, once a week, together with a health education program. Receives: Other: Perineal massage |
| Treatment with dilators | Active comparator | A health education session will be held but then the use of vaginal dilators will be done according to the gold standard treatment. Receives: Other: Standard treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain (Visual Analoge Scale)
Visual Analogical Scale (VAS) is a unidimensional measure of pain intensity, used to record patients' pain progression, or compare pain severity between patients with similar conditions. VAS is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured orientated from the left "0" (worst) to the right "10"(best)
Measured: Change from baseline at six months
Secondary outcomes (4)
Criteria for Adverse Events (CTCAE)
Grade refers to the severity of the Adverse Events. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on a general guideline where grade 1 and grade 5 are the best and worst result respectively.
Measured: Change from baseline at six months
Quality of life (EORCT QLQ-C30)
The EORTC QLG Core Questionnaire (EORTC QLQ-C30) is a 30-item instrument designed to measure quality of life in all cancer patients. The scores obtained can have values between 0 and 100, which determines the level of impact of the cancer on the patient of each of the scales. High values on the global health and function status scales indicate a better quality of life, while on the symptoms scale it would indicate a decrease in quality of life since it indicates the presence of symptoms associated with cancer.
Measured: Change from baseline at six months
Female sexual function index
Female sexual function index (FSFI) is a survey measuring the sexual functioning of women in six different domains: desire, arousal, lubrication, orgasm, satisfaction and pain.The items are then scaled to achieve a maximum score of 36.
Measured: Change from baseline at six months
Likert questionnaire by sexual dysfunction
Likert scales are a structured way for researchers to gather diverse opinions and attitudes. They allow respondents to express agreement, disagreement, or neutrality concerning statements or questions. The scale values range from 1 to 5, with 1 being the worst result and 5 being the best result.
Measured: Change from baseline at six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2024
- Study start31 May 2024
- Primary completion20 Dec 2025
- Study completion20 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cancer PainStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alcala
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Daniel Pecos Martín, University of Alcala
- Investigators
- Raquel Perez-García, Principal investigator, Asociación Española Contra el Cáncer en la provincia de Santa cruz de Tenerife.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06432998
- Sponsor's protocol ID
- CHUNSC_2023_104
- Status last verified
- Apr 2026
- First submitted
- 22 May 2024
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Perez-Garcia R, Abuin-Porras V, Minguez-Esteban I, Pecos-Martin D. Oncological perineal massage in vaginal stenosis and dyspareunia in women with gynecological cancer: a randomized controlled trial. Front Oncol. 2025 Nov 28;15:1680126. doi: 10.3389/fonc.2025.1680126. eCollection 2025.
PubMed 41395600
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oncological Perineal Massage in Vaginal Stenosis and Dyspareunia in Women With Gynecological Cancer
- ClinicalTrials.gov ID
- NCT06432998
- Acronym / sponsor ID
- CHUNSC_2023_104
- Conditions
- Cancer Pain, Neck Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of AlcalaUniversity, hospital or other
- Study start
- 31 May 2024 (actual)
- Primary completion
- 20 Dec 2025 (actual)
- Study completion
- 20 Dec 2025 (actual)
- First posted
- 29 May 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.
The high incidence of gynecological cancers, together with dyspareunia and vaginal stenosis, some of its most frequent sequelae, create the need to continue studying and researching oncological physiotherapy techniques that treat and prevent these sequelae, in order to preserve and/or improve the quality of life of cancer patients. Therefore, through this study, we sought to verify the effectiveness of oncological perineal massage to treat pain during sexual intercourse and vaginal stenosis.
The objective of this study will be to demonstrate the effectiveness of a treatment that will consist of a health education session related to the pelvic floor and the consequences related to cancer along with ten sessions of oncological perineal massage that will be carried out for fifty minutes, once a week.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Perineal massage | Experimental | Other: Perineal massageTen sessions of perineal massage, which will be carried out for fifty minutes, once a week, together with a health education program. |
| Treatment with dilators | Active comparator | Other: Standard treatmentA health education session will be held but then the use of vaginal dilators will be done according to the gold standard treatment. |
Who may qualify
- Ages
- 18 to 52 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women between 18 and 52 years old
- Oncology patients with a diagnosis of dyspareunia and vaginal stenosis related to treatments.
- Patients with QT/RT/BT treatment who have a diagnosis of dyspareunia and vaginal stenosis.
- Patients on hormonal suppressive treatment with a diagnosis of dyspareunia and vaginal stenosis.
Key exclusion criteria (5 listed)
- Patients who do not accept intracavitary treatment.
- Patients with abdominopelvic surgical treatment prior to oncological process.
- Patients with a diagnosis of dyspareunia prior to cancer.
- Patients with vaginal narrowing prior to cancer.
- Patients with menopause at the time of cancer diagnosis
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 |
|---|---|---|
| Perineal massageThe technique will be applied for approximately twenty minutes and will be carried out as follows: the vaginal dilator is introduced progressively using crescent-shaped movements. Once the dilator is fully inserted, movements will be made from bottom to top and from one side to the other, and then continue with the crescent-shaped movements. | Other | Perineal massage |
| Standard treatmentThe treatment will consist of the use of vaginal dilators according to the gold standard proposed in the literature. It will consist of introducing the same dilators as for the experimental group, with the same time schedule, but without massage, only introducing the dilator and keeping it in the vagina for 20 minutes. | Other | Treatment with dilators |
Primary outcome
Pain (Visual Analoge Scale)
Time frame: Change from baseline at six months
Visual Analogical Scale (VAS) is a unidimensional measure of pain intensity, used to record patients' pain progression, or compare pain severity between patients with similar conditions. VAS is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured orientated from the left "0" (worst) to the right "10"(best)
4 secondary outcomes
Criteria for Adverse Events (CTCAE)
Time frame: Change from baseline at six months
Quality of life (EORCT QLQ-C30)
Time frame: Change from baseline at six months
Female sexual function index
Time frame: Change from baseline at six months
Likert questionnaire by sexual dysfunction
Time frame: Change from baseline at six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Derived from this study: PubMed 41395600Perez-Garcia R, Abuin-Porras V, Minguez-Esteban I, Pecos-Martin D. Oncological perineal massage in vaginal stenosis and dyspareunia in women with gynecological cancer: a randomized controlled trial. Front Oncol. 2025 Nov 28;15:1680126. doi: 10.3389/fonc.2025.1680126. eCollection 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.
Raquel Perez-García principal investigator
Asociación Española Contra el Cáncer en la provincia de Santa cruz de Tenerife.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Perineal massage and Standard treatment in people with Cancer Pain and Neck Cancer, run by University of Alcala 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 4 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: finished, as of the sponsor's last update on 1 May 2026. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pain (Visual Analoge Scale) (time frame: Change from baseline at six months). 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 NCT06432998, which also lists 1 linked publication.
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 1 May 2026.