Clinical Benefit of Spa Care on Severe Radiation-induced Fibrosis After Postoperative Radiotherapy for Breast Cancer
FIBROTHERME
Evaluation of the Clinical Benefit of a Spa Care on the Evolution of Late Fibrosis After Postoperative Radiotherapy for Breast Cancer in Remission
1 other identifier
interventional
142
1 country
21
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Dec 2018
Typical duration for phase_3
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 8, 2016
CompletedFirst Posted
Study publicly available on registry
September 13, 2016
CompletedStudy Start
First participant enrolled
December 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedAugust 8, 2018
August 1, 2018
1.6 years
September 8, 2016
August 7, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
Dermatology Quality of life at 12 months
12 months after the end of treatment
Overall quality of life
6 months
Breast-oriented quality of life
6 months
late radiation toxicity
6 months
Skin thickness
6 months
- +1 more secondary outcomes
Study Arms (2)
combination tocopherol/pentoxifylline + spa care
EXPERIMENTALpentoxifylline (400 mg bid) + tocopherol (500 mg x bid) during at least 6 months AND skin-oriented spa care (18 days)
combination tocopherol/pentoxifylline
ACTIVE COMPARATORpentoxifylline (400 mg bid) + tocopherol (500 mg x bid) during at least 6 months
Interventions
standardized procedure : 72 care sessions over 18 days of treatment +/- Additional care according to the specificity of each spa
400 mg bid during at least 6 months
500 mg bid during at least 6 months
Eligibility Criteria
You may qualify if:
- 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)
- ability to provide an informed written consent form
- affiliation to a social security system
You may not qualify if:
- age \<18 or ≥ 80 years old
- evolutive cancer
- Metastatic Disease
- bilateral Breast/chest wall Radiotherapy
- breast prosthesis bearer
- Body Mass Index \> 40 or \<18.5
- contraindications to spa care :
- 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
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
CHU de Besançon Hôpital Jean Minjoz
Besançon, 25000, France
ONCODOC
Béziers, 34500, France
Centre d'Oncologie et de Radiothérapie du Parc
Chalon-sur-Saône, 71100, France
Clinique du Parc de Charleville-Mézières
Charleville-Mézières, 08000, France
CLCC Jean Perrin
Clermont-Ferrand, 63000, France
Hôpitaux Civils de Colmar
Colmar, 68000, France
Centre Georges-François Leclerc
Dijon, 21079, France
Institut Daniel Hollard
Grenoble, 38000, France
CHU de Grenoble, Hôpital A.Michallon
La Tronche, 38700, France
CHR Metz-Thionville Hôpital de Mercy
Metz, France
CH de Belfort-Montbéliard Site du Mittan
Montbéliard, 25200, France
CH de Mulhouse
Mulhouse, 68100, France
Centre d'Oncologie de Gentilly
Nancy, 54100, France
CHU de Poitiers
Poitiers, 86000, France
Institut Jean Godinot de Reims
Reims, 51100, France
CLCC Saint Etienne
Saint-Priest-en-Jarez, 42270, France
Centre Paul Strauss
Strasbourg, 67000, France
Clinique de l'Orangerie
Strasbourg, 67000, France
Institut Universitaire du Cancer
Toulouse, 31000, France
CH de Troyes
Troyes, 10000, France
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, 54519, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
VOGIN Guillaume, MD,PhD
Institut de Cancérologie de Lorraine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 8, 2016
First Posted
September 13, 2016
Study Start
December 1, 2018
Primary Completion
July 1, 2020
Study Completion
December 1, 2021
Last Updated
August 8, 2018
Record last verified: 2018-08
Data Sharing
- IPD Sharing
- Will not share