## Protocol Section
### Identification Module
**NCT ID:** NCT06432998

**Brief Title:** Perineal Massage in Women With Gynecological Cancer

**Official Title:** Oncological Perineal Massage in Vaginal Stenosis and Dyspareunia in Women With Gynecological Cancer

#### Organization Study ID Info
**ID:** CHUNSC_2023_104
#### Organization
**Class:** OTHER
**Full Name:** University of Alcala
### Status Module
#### Completion Date
**Date:** 2024-12-03

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-29

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-09-03

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06-03

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Alcala

#### Responsible Party

**Investigator Affiliation:** University of Alcala

**Investigator Full Name:** Prof. Dr. Daniel Pecos Martín

**Investigator Title:** Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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 Module

**Conditions:**

- Cancer Pain

- Neck Cancer

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 86

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Ten sessions of perineal massage, which will be carried out for fifty minutes, once a week, together with a health education program.

**Intervention Names:**

- Other: Perineal massage

**Label:** Perineal massage

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** A health education session will be held but then the use of vaginal dilators will be done according to the gold standard treatment.

**Intervention Names:**

- Other: Standard treatment

**Label:** Treatment with dilators

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Perineal massage

**Description:** 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.

**Name:** Perineal massage

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- Treatment with dilators

**Description:** 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.

**Name:** Standard treatment

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** 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)

**Measure:** Pain (Visual Analoge Scale)

**Time Frame:** Change from baseline at six months

#### Secondary Outcomes

**Description:** 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.

**Measure:** Criteria for Adverse Events (CTCAE)

**Time Frame:** Change from baseline at six months

**Description:** 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.

**Measure:** Quality of life (EORCT QLQ-C30)

**Time Frame:** Change from baseline at six months

**Description:** 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.

**Measure:** Female sexual function index

**Time Frame:** Change from baseline at six months

**Description:** 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.

**Measure:** Likert questionnaire by sexual dysfunction

**Time Frame:** Change from baseline at six months

### Eligibility Module

**Eligibility Criteria:** 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

**Gender Based:** True

**Gender Description:** Women diagnosed with vaginal stenosis and dyspareunia due to cancer

**Maximum Age:** 52 Years

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** tenerife@contraelcancer.es

**Name:** Raquel Perez-Garcia

**Phone:** +34 922276912

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Santa cruz de Tenerife.

**Contacts:**

***Contact 1:***

- **Email:** tenerife@contraelcancer.es

- **Name:** Raquel Perez-Garcia

- **Phone:** +34 922276912

- **Role:** CONTACT

**Country:** Spain

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

**State:** Tenerife

#### Overall Officials

**Official 1:**

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

**Name:** Raquel Perez-García

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010146

- Term: Pain

- ID: D000009461

- Term: Neurologic Manifestations

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: BC10

- Name: Nervous System Diseases

### Condition Browse Module - Browse Leaves

- ID: M1091

- Name: Cancer Pain

- Relevance: HIGH

- As Found: Cancer Pain

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M6475

- Name: Constriction, Pathologic

- Relevance: LOW

- As Found: Unknown

- ID: M7588

- Name: Dyspareunia

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000072716

- Term: Cancer Pain

### Misc Info Module

- Version Holder: 2024-05-31
