Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Uterine Cervical Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Standard care according to the modalities of each center (concomitant treatment prescription, psychological support, physiotherapy or dietetic are supports that can be proposed if needed)

Standard support with Daily realization of a session of Kine-Yoga supervised by a physiotherapist at J2, J3 and J4 of uterovaginal brachytherapy.

Possibility for the patient to practice this session in autonomy (using PEP tools given to the Shared Educational Check-up) according to her wish during the duration of the treatment and up to 15 days post treatment.

Daily performance of a Kine-Yoga-PEP intervention supervised by a physiotherapist of the department trained in the Kine-Yoga-PEP intervention at J2, J3 and J4 of uterovaginal brachytherapy.

Possibility for the patient to practice this session in autonomy (using PEP tools given to the Shared Educational Check-up) according to her wish during the duration of the treatment and up to 15 days post treatment

session of Kine-Yoga

Emmanuelle TEXIER

Laetitia MEIGNANT

Kerstin FARAVEL

Corale GEFFROY

Anne DUCASSOU, MD

Aurore MOUSSION

Every year in France, nearly 3,000 women develop a cervical cancer. The average age of women diagnosed is 51. Uterovaginal brachytherapy is one of the reference treatments.

To allow this treatment, an applicator is first placed under general anaesthesia in the vaginal zone. Then, the pulsed Dose Rate (PDR) or high dose rate (HDR) uterovaginal brachytherapy requires 2-5 days hospitalization in an isolated room. Uterovaginal brachytherapy requires strict bed rest without movements allowed for the pelvic area until the applicator is removed.

Prolonged immobilization, the context of the illness and the intimacy of the area to be treated are all recognized sources of anxiety. According to a study, 40% of patients have post-traumatic stress at 3 months of treatment. A Danish team highlights the significant decrease in physical capacity during and after treatment.

Thus, as a recent literature review concludes, there is a real need to develop Non-Pharmacological-Interventions (NPI) to limit the aftereffects. It also seems important to provide support for self-management of symptoms.

Among NPI of interest, Yoga is a mind-body practice that can decrease perceived stress. A systematic review confirms that yoga can reduce stress during cancer treatment. This underlines the importance of proposing this practice for patients treated for all types of cancers and further evaluations on the effects of respiratory and meditation exercises. Another team showed the feasibility of respiratory exercise intervention in patients undergoing chemotherapy while also talking about mental health benefits. Finally, a reduction in perceived stress was achieved in women treated with radiotherapy for breast cancer through yoga intervention. A lot of work has been done with promising results without the result of a consensus applicable to all care situations.

Moreover, educational requirements are high in women treated to gynecological cancer.

Meeting these needs helps to improve quality of life, pain management and drug use.

Integrating Patient Educational Project (PEP) therefore seems relevant as an additional tool in patient empowerment. In addition, the fact that a combined Physiotherapy-Yoga-PEP intervention is feasible in women treated for breast cancer allows us to offer adjusted version in patients with brachytherapy.

The literature review thus invites us to propose the educational intervention Kine-Yoga-PEP in the very particular context of brachytherapy.

Control Group: Standard care according to the modalities of each center (concomitant treatment prescription, psychological support, physiotherapy or dietetic are supports that can be proposed if needed) Experimental Group: Standard support with Daily realization of a session of Kine-Yoga supervised by a physiotherapist at J2, J3 and J4 of uterovaginal brachytherapy.

Impact of an Educational Physiotherapy-Yoga Intervention on Perceived Stress in Women Treated With Brachytherapy for Cervical Cancer

Impact of an Educational Physiotherapy-Yoga Intervention on Perceived Stress in Women Treated With Brachytherapy for Cervical Cancer: a Randomized Controlled Trial

The Perceived Stress Score will be assessed by the 10-item Perceived Stress Scale (PSS) self-assessment 15 days after the start of the uterovaginal brachytherapy.

The safety will be evaluated by Number of treatment interruptions due to applicator displacement and/or source friction following Kine-Yoga-PEP intervention. Patient compliance will be evaluated by the number of sessions performed (supervised and independent) collected on the logbooks filled out by the patients

Scores obtained at the Visual Analog Scales (VAS) of stress and EVA of pain (global and immobility-related), before and after Kine-Yoga-PEP intervention and during uterovaginal brachytherapy.

Fatigue score obtained on Visual Analogue Scale (VAS) during uterovaginal brachytherapy

Anxiety-Depressive Distress Score measured by the Hospital Anxiety and Depression Scale (HADS) Questionnaire for uterovaginal Brachytherapy at inclusion and 15 days after the uterovaginal brachytherapy

The use of anxiolytic treatments will be described in the logbooks filled out by the patients

The diversity of verbatim and semantic themes collected by a 40 - 60 minute semi-directional interview (qualitative analysis) in the week following the removal of the applicator from patients until data saturation (approximately 20 patients in the experimental group

Institut du Cancer de Montpellier - Val d'Aurelle

Antineoplastic Agents

All Drugs and Chemicals

Cisplatin

Chelating Agents

Three intravenous injections of AGuIX will be delivered.

The first injection of AGuIX will be delivered intravenously the 1st day and the 11th day of EBRT. The first injection will be preceded with an MRI (unenhanced T1 and T2 sequences) then followed with another MRI performed 4 hours later, to monitor tumor uptake.

Irradiation will be performed after the second MRI.

The second injection will be followed by an MRI 4 hours later.

The third injection will be delivered intravenously the day of the brachytherapy procedure. Intravenous hydration will be performed during all brachytherapy courses to ensure AGuIX clearance.

Up to three dose levels may be explored: 20mg/kg (level -1), 30 mg/kg (level 1) and 50 mg/kg (level 2). The starting dose level will be 30mg/kg.

Polysiloxane Gd-Chelates based nanoparticles (AGuIX)

to the pelvis, with intensity modulated technique: 45 Gy in 5 weeks, with integrated boost to 55 - 57.5 Gy in case of macroscopic lymph node metastases

External beam radiotherapy (EBRT)

15 Gy (maximal interval between EBRT and brachytherapy: 14 days).

Uterovaginal brachytherapy

Concomitant weekly intravenous cisplatin 40 mg/m2 will be delivered (total 5 cycles).

Chemotherapy (cisplatin)

Cyrus CHARGARI, MD

Matthieu TEXIER

Ionela CARAIVAN, MD

This is a phase 1 clinical trial evaluating the safety, tolerability of escalating doses of AGuIX-NP in combination with radiation and cisplatin in patients with locally advanced cervical cancer. Dose escalation will be conducted using the modified toxicity probability interval (mTPI) method.

Three dose levels of intravenous AGuIX nanoparticles will be explored: 20mg/kg (level -1), 30 mg/kg (level 1) and 50 mg/kg (level 2).

This is a phase 1 clinical trial evaluating the safety, tolerability of escalating doses of AGuIX-NP in combination with radiation and cisplatin in patients with locally advanced cervical cancer. Dose escalation will be conducted using the modified toxicity probability interval (mTPI) method. Three dose levels of intravenous AGuIX nanoparticles will be explored: 20mg/kg (level -1), 30 mg/kg (level 1) and 50 mg/kg (level 2).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Impact of an Educational Physiotherapy-Yoga Intervention on Perceived Stress in Women Treated With Brachytherapy for Cervical Cancer	NCT06263283	Cervical Cancer Brachytherapy	session of Kine...	18 Years -	Institut du Cancer de Montpellier - Val d'Aurelle
AGuIX Gadolinium-based Nanoparticles in Combination With Chemoradiation and Brachytherapy	NCT03308604	Gynecologic Can...	Polysiloxane Gd... External beam r... Uterovaginal br... Chemotherapy (c...	18 Years - 70 Years	Gustave Roussy, Cancer Campus, Grand Paris
AGuIX Gadolinium-based Nanoparticles in Combination With Chemoradiation and Brachytherapy	NCT03308604	Gynecologic Can...	Polysiloxane Gd... External beam r... Uterovaginal br... Chemotherapy (c...	18 Years - 70 Years	Gustave Roussy, Cancer Campus, Grand Paris
AGuIX Gadolinium-based Nanoparticles in Combination With Chemoradiation and Brachytherapy	NCT03308604	Gynecologic Can...	Polysiloxane Gd... External beam r... Uterovaginal br... Chemotherapy (c...	18 Years - 70 Years	Gustave Roussy, Cancer Campus, Grand Paris

Spots Global Cancer Trial Database for uterovaginal brachytherapy