Perineal Massage in Women With Gynecological Cancer

Not Applicable

Recruiting

• Conditions: Cancer Pain; Neck Cancer
• Interventions: Other: Perineal massage; Other: Standard treatment

• Registration Number: NCT06432998
• Lead Sponsor: University of Alcala

Brief 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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-05-22
• Study First Submitted QC: 2024-05-22
• Study First Posted: 2024-05-29
• Study Start: 2024-05-31
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-12
• Last Update Posted: 2025-03-13
• Primary Completion: 2025-03-20
• Study Completion: 2025-06-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 86

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Perineal massage	Perineal massage	Ten sessions of perineal massage, which will be carried out for fifty minutes, once a week, together with a health education program.
Treatment with dilators	Standard treatment	A health education session will be held but then the use of vaginal dilators will be done according to the gold standard treatment.

Primary Outcome Measures

Name	Time	Method
Pain (Visual Analoge Scale)	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)

Secondary Outcome Measures

Name	Time	Method
Female sexual function index	Change from baseline at six months	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.
Criteria for Adverse Events (CTCAE)	Change from baseline at six months	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.
Quality of life (EORCT QLQ-C30)	Change from baseline at six months	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.
Likert questionnaire by sexual dysfunction	Change from baseline at six months	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.

Trial Locations

Locations (1)

Asociación Española Contra el Cáncer en la provincia de Santa cruz de Tenerife.; 🇪🇸 Santa cruz de Tenerife., Tenerife, Spain