Perineal Massage in Women With Gynecological Cancer

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.

Study Overview

• Status: Recruiting
• Conditions: Cancer Pain; Neck Cancer
• Intervention / Treatment: Other: Perineal massage; Other: Standard treatment

• Study Type: Interventional
• Enrollment (Estimated): 86
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Raquel Perez-Garcia; Phone Number: +34 922276912; Email: tenerife@contraelcancer.es

Study Locations

• Spain
  • Tenerife
    • Santa cruz de Tenerife., Tenerife, Spain
      • Recruiting
      • Asociación Española Contra el Cáncer en la provincia de Santa cruz de Tenerife.
      • Contact: Raquel Perez-Garcia; Phone Number: +34 922276912; Email: tenerife@contraelcancer.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Change from baseline at six months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	Change from baseline at six months

Collaborators and Investigators

• Sponsor: University of Alcala
• Investigators: Principal Investigator: Raquel Perez-García, Asociación Española Contra el Cáncer en la provincia de Santa cruz de Tenerife.

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2024
• Primary Completion (Estimated): September 3, 2024
• Study Completion (Estimated): December 3, 2024

Study Registration Dates

• First Submitted: May 22, 2024
• First Submitted That Met QC Criteria: May 22, 2024
• First Posted (Actual): May 29, 2024

Study Record Updates

• Last Update Posted (Actual): June 3, 2024
• Last Update Submitted That Met QC Criteria: May 31, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Cancer Pain
• Other Study ID Numbers: CHUNSC_2023_104

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No