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

NCT ID: NCT02898376

Last Updated: 2018-08-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 142 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-31
• Study Completion Date: 2021-12-31

Brief 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.

Detailed 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.

Conditions

Breast Carcinoma; Fibrosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

combination tocopherol/pentoxifylline + spa care

pentoxifylline (400 mg bid) + tocopherol (500 mg x bid) during at least 6 months AND skin-oriented spa care (18 days)

Group Type: EXPERIMENTAL

skin-oriented spa care

Intervention Type: OTHER

standardized procedure : 72 care sessions over 18 days of treatment

+/- Additional care according to the specificity of each spa

Pentoxifylline

Intervention Type: DRUG

400 mg bid during at least 6 months

Tocopherol acetate

Intervention Type: DRUG

500 mg bid during at least 6 months

combination tocopherol/pentoxifylline

pentoxifylline (400 mg bid) + tocopherol (500 mg x bid) during at least 6 months

Group Type: ACTIVE_COMPARATOR

Pentoxifylline

Intervention Type: DRUG

400 mg bid during at least 6 months

Tocopherol acetate

Intervention Type: DRUG

500 mg bid during at least 6 months

Interventions

skin-oriented spa care

standardized procedure : 72 care sessions over 18 days of treatment

+/- Additional care according to the specificity of each spa

Intervention Type: OTHER

Pentoxifylline

400 mg bid during at least 6 months

Intervention Type: DRUG

Tocopherol acetate

500 mg bid during at least 6 months

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Association Francaise pour la Recherche Thermale

OTHER

Sponsor Role: collaborator

Institut de Cancérologie de Lorraine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

VOGIN Guillaume, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Institut de Cancérologie de Lorraine

Locations

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

Vandœuvre-lès-Nancy, , France

Countries

France

Central Contacts

MERLIN Jean Louis

Role: CONTACT

jl.merlin@nancy.unicancer.fr

0033383598307

FERNANDES Laurinda

Role: CONTACT

l.fernandes@nancy.unicancer.fr

0033383598487

Facility Contacts

Bontemps Patrick, MD

Role: primary

Levecq Jean-Marc, MD

Role: primary

Schipman Benjamin, MD

Role: primary

Jonveaux Eric, MD

Role: primary

Belliere-Calandry Aurélie, MD

Role: primary

Boutenbat Ghizlane, MD

Role: primary

Peignaux Karine, MD

Role: primary

Claeys Marie-Virginie, MD

Role: primary

Gabelle - Flandin Isabelle, MD

Role: primary

Quetin Philippe, MD

Role: primary

Boulbair Fatiha, MD

Role: primary

Grandgirard Alain, MD

Role: primary

Marquis Isabelle, MD

Role: primary

El Hajj Labib, MD

Role: primary

Guilbert Philippe, MD

Role: primary

Magné Nicolas, MD

Role: primary

Salze Pierre, MD

Role: primary

Karst Anne, MD

Role: primary

Massabeau Carole, MD

Role: primary

Beaumont Claudine, MD

Role: primary

VOGIN Guillaume, MD

Role: primary

g.vogin@nancy.unicancer.fr

Other Identifiers

2016-003518-28

Identifier Type: -

Identifier Source: org_study_id