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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02898376
Other study ID # 2016-003518-28
Secondary ID
Status Not yet recruiting
Phase Phase 3
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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