Perineal Massage in Women With Gynecological Cancer

NCT06432998 | Completed

• 1 other identifier: CHUNSC_2023_104
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer Pain; Neck Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Criteria for Adverse Events (CTCAE)

  Change from baseline at six months

• Quality of life (EORCT QLQ-C30)

  Change from baseline at six months

• Female sexual function index

  Change from baseline at six months

• Likert questionnaire by sexual dysfunction

  Change from baseline at six months

Study Arms (2)

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.

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.

Other: Standard treatment

Interventions

Perineal massage OTHER

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.

Perineal massage

Standard treatment OTHER

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.

Treatment with dilators

Eligibility Criteria

• Age: 18 Years - 52 Years
• Gender Eligibility Details: Women diagnosed with vaginal stenosis and dyspareunia due to cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alcala: lead

Study Sites (1)

Asociación Española Contra el Cáncer en la provincia de Santa cruz de Tenerife.

Santa Cruz de Tenerife, Tenerife, Spain

Location

Related Publications (1)

• 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.

  PMID: 41395600 DERIVED

MeSH Terms

Conditions

Cancer Pain; Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms

Study Officials

• Raquel Perez-García

  Asociación Española Contra el Cáncer en la provincia de Santa cruz de Tenerife.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 22, 2024
• First Posted: May 29, 2024
• Study Start: May 31, 2024
• Primary Completion: December 20, 2025
• Study Completion: December 20, 2025
• Last Updated: May 1, 2026

Record last verified: 2026-04

Locations

ES (1)