Clinical Benefit of Spa Care on Severe Radiation-induced Fibrosis After Postoperative Radiotherapy for Breast Cancer

Breast Carcinoma Clinical Trial

— FIBROTHERME  

Official title:

Evaluation of the Clinical Benefit of a Spa Care on the Evolution of Late Fibrosis After Postoperative Radiotherapy for Breast Cancer in Remission

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02898376
• Other study ID #: 2016-003518-28
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: December 2018
• Est. completion date: December 2021

Study information

• Verified date: August 2018
• Source: Institut de Cancérologie de Lorraine
• Contact: MERLIN Jean Louis
• Phone: 0033383598307
• Email: jl.merlin[@]nancy.unicancer.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study evaluates the dermatological life quality six months after spa cares in patients with severe late toxicity involving the skin and / or soft tissues after postoperative radiotherapy for breast cancer. Half of the patients will be treated with a combination of pentoxifylline (PTX) and alpha-tocopherol (Vit E) when Half of the patients will receive skin-oriented spa cares in addition.

Description:

The combination of PTX and vit E appears as the standard treatment of radiation induced fibrosis. Synergism between PTX and Vit E is likely, as treatment with each drug alone is ineffective. This combination was also positively evaluated in the treatment of osteoradionecrosis, radiation-induced pelvic neuropathies, pneumoniae as well as bowel pathologies.

Spa cares are part of the standard treatment of burn scars. Two spa treatments per year enable the mitigation or disappearance (after several treatments) of pruritus, dysesthesia, local inflammation, hypertrophy and sclerosis. They promote the healing of chronic superficial erosions. The spa treatment combines baths, sprays and especially filiform showers with thermal water jets under high pressure for a few minutes.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 142
• Est. completion date: December 2021
• Est. primary completion date: July 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• women

• age = 18 and <80 years old

• invasive or in situ breast carcinoma

• non-metastatic disease.

• postoperative radiotherapy completed since at least 6 months

• unilateral breast radiotherapy

• grade > 2 dermal and/or soft tissue toxicity (CTCAE v4.0)

• no inflammatory ou infectious flare on the breast at the time of inclusion

• ability to provide an informed written consent form

• affiliation to a social security system

Exclusion Criteria:

• age <18 or = 80 years old

• evolutive cancer

• Metastatic Disease

• Patient undergoing specific treatment for breast cancer (except adjuvant endocrine therapy and / or adjuvant Herceptin) at the time of inclusion

• bilateral Breast/chest wall Radiotherapy

• breast prosthesis bearer

• Body Mass Index > 40 or <18.5

• chronic skin ulceration within the treated breast at the time of inclusion

• contraindications to spa care :

• inflammatory disease in flare at the time of inclusion

• active infections

• heart failure (NYHA class> 1)

• chronic respiratory failure

• labile blood pressure

• bullous dermatitis

• evolutive chronic skin disease

• hypersensitivity to pentoxifylline or any of the excipients

• acute myocardial infarction

• ongoing hemorrhage or major bleeding risk

• use of oral anticoagulants

• pregnant or likely to be in 6 months or breastfeeding

• patients deprived of liberty or under supervision

Related Conditions & MeSH terms

• Breast Carcinoma
• Breast Neoplasms
• Fibrosis

Intervention

Other:
• skin-oriented spa care
standardized procedure : 72 care sessions over 18 days of treatment +/- Additional care according to the specificity of each spa

Drug:
• Pentoxifylline
400 mg bid during at least 6 months
• Tocopherol acetate
500 mg bid during at least 6 months

Locations

Country	Name	City	State
France	CHU de Besançon Hôpital Jean Minjoz	Besançon
France	ONCODOC	Béziers
France	Centre d'Oncologie et de Radiothérapie du Parc	Chalon-sur-Saône
France	Clinique du Parc de Charleville-Mézières	Charleville-Mézières
France	CLCC Jean Perrin	Clermont Ferrand
France	Hôpitaux Civils de Colmar	Colmar
France	Centre Georges-François Leclerc	Dijon
France	Institut Daniel Hollard	Grenoble
France	CHU de Grenoble, Hôpital A.Michallon	La Tronche
France	CHR Metz-Thionville Hôpital de Mercy	Metz
France	CH de Belfort-Montbéliard Site du Mittan	Montbéliard
France	CH de Mulhouse	Mulhouse
France	Centre d'Oncologie de Gentilly	Nancy
France	CHU de Poitiers	Poitiers
France	Institut Jean Godinot de Reims	Reims
France	CLCC Saint Etienne	Saint-Priest en Jarez
France	Centre Paul Strauss	Strasbourg
France	Clinique de l'Orangerie	Strasbourg
France	Institut Universitaire du Cancer	Toulouse
France	CH de Troyes	Troyes
France	Institut de Cancérologie de Lorraine	Vandoeuvre-les-Nancy

Sponsors (2)

Lead Sponsor	Collaborator
Institut de Cancérologie de Lorraine	Association Francaise pour la Recherche Thermale

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dermatology Quality of life at 6 months	Self-reported dermatology quality of life using the standardized Dermatology Life Quality Index (DLQI) ; This score assess the functional impact of fibrosis: eg. intensity of pain, itching... (10 items). The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.	6 months after the end of treatment
Secondary	Dermatology Quality of life at 12 months	Self-reported dermatology quality of life using the standardized Dermatology Life Quality Index (DLQI) ; This score assess the functional impact of fibrosis: eg. intensity of pain, itching... (10 items). The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.	12 months after the end of treatment
Secondary	Overall quality of life	quality of life questionnaire (EORTC QLQ C30 score)	6 months
Secondary	Breast-oriented quality of life	EORTC QLQ-BR23 score	6 months
Secondary	late radiation toxicity	Evaluation of late toxicity performed independently and in blind by another radiation oncologist from the same center, using the CTCAE v4.0 scale modules: Skin and subcutaneous tissue disorders / Musculoskeletal skeletal / Reproductive organs and breast	6 months
Secondary	Skin thickness	The skin thickness will be assessed in blind by an independently radiologist using a standardized Ultrasound scan procedure (Yoshida EJ, et al; Int J Radiat Oncol Biol Phys. 2012) Skin thickness is measured as the distance between the entry ultrasound echo signal to the border between the dermis and hypodermis . Measurements are acquired from ten locations: five on the treated (irradiated) breast (12:00, 3:00, 6:00, 9:00, and tumor bed), and five corresponding locations on the untreated (contralateral) breast - serving as controls to account for patient baseline variation	6 months
Secondary	Cosmetic appearance	The cosmetic appearance will be evaluated by the investigator with the Harvard-breast-cosmesis-scale (HBCS). HBCS classifies the overall aesthetic results in four categories from excellent, good, fair to poor; comparing the treated breast to the control breast	6 months