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

Primary Purpose

Breast Carcinoma, Fibrosis

Status
Unknown status
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
skin-oriented spa care
Pentoxifylline
Tocopherol acetate
Sponsored by
Institut de Cancérologie de Lorraine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Carcinoma focused on measuring spa care, randomised controlled trial, pentoxifylline/tocopherol combination, late sequelae, radiotherapy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • CHU de Besançon Hôpital Jean Minjoz
  • ONCODOC
  • Centre d'Oncologie et de Radiothérapie du Parc
  • Clinique du Parc de Charleville-Mézières
  • CLCC Jean Perrin
  • Hôpitaux Civils de Colmar
  • Centre Georges-François Leclerc
  • Institut Daniel Hollard
  • CHU de Grenoble, Hôpital A.Michallon
  • CHR Metz-Thionville Hôpital de Mercy
  • CH de Belfort-Montbéliard Site du Mittan
  • CH de Mulhouse
  • Centre d'Oncologie de Gentilly
  • CHU de Poitiers
  • Institut Jean Godinot de Reims
  • CLCC Saint Etienne
  • Centre Paul Strauss
  • Clinique de l'Orangerie
  • Institut Universitaire du Cancer
  • CH de Troyes
  • Institut de Cancérologie de Lorraine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

combination tocopherol/pentoxifylline + spa care

combination tocopherol/pentoxifylline

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Overall quality of life
quality of life questionnaire (EORTC QLQ C30 score)
Breast-oriented quality of life
EORTC QLQ-BR23 score
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
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
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

Full Information

First Posted
September 8, 2016
Last Updated
August 7, 2018
Sponsor
Institut de Cancérologie de Lorraine
Collaborators
Association Francaise pour la Recherche Thermale
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1. Study Identification

Unique Protocol Identification Number
NCT02898376
Brief Title
Clinical Benefit of Spa Care on Severe Radiation-induced Fibrosis After Postoperative Radiotherapy for Breast Cancer
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
December 2018 (Anticipated)
Primary Completion Date
July 2020 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut de Cancérologie de Lorraine
Collaborators
Association Francaise pour la Recherche Thermale

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Carcinoma, Fibrosis
Keywords
spa care, randomised controlled trial, pentoxifylline/tocopherol combination, late sequelae, radiotherapy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
142 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
combination tocopherol/pentoxifylline + spa care
Arm Type
Experimental
Arm Description
pentoxifylline (400 mg bid) + tocopherol (500 mg x bid) during at least 6 months AND skin-oriented spa care (18 days)
Arm Title
combination tocopherol/pentoxifylline
Arm Type
Active Comparator
Arm Description
pentoxifylline (400 mg bid) + tocopherol (500 mg x bid) during at least 6 months
Intervention Type
Other
Intervention Name(s)
skin-oriented spa care
Intervention Description
standardized procedure : 72 care sessions over 18 days of treatment +/- Additional care according to the specificity of each spa
Intervention Type
Drug
Intervention Name(s)
Pentoxifylline
Intervention Description
400 mg bid during at least 6 months
Intervention Type
Drug
Intervention Name(s)
Tocopherol acetate
Intervention Description
500 mg bid during at least 6 months
Primary Outcome Measure Information:
Title
Dermatology Quality of life at 6 months
Description
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.
Time Frame
6 months after the end of treatment
Secondary Outcome Measure Information:
Title
Dermatology Quality of life at 12 months
Description
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.
Time Frame
12 months after the end of treatment
Title
Overall quality of life
Description
quality of life questionnaire (EORTC QLQ C30 score)
Time Frame
6 months
Title
Breast-oriented quality of life
Description
EORTC QLQ-BR23 score
Time Frame
6 months
Title
late radiation toxicity
Description
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
Time Frame
6 months
Title
Skin thickness
Description
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
Time Frame
6 months
Title
Cosmetic appearance
Description
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
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
MERLIN Jean Louis
Phone
0033383598307
Email
jl.merlin@nancy.unicancer.fr
First Name & Middle Initial & Last Name or Official Title & Degree
FERNANDES Laurinda
Phone
0033383598487
Email
l.fernandes@nancy.unicancer.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
VOGIN Guillaume, MD,PhD
Organizational Affiliation
Institut de Cancérologie de Lorraine
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Besançon Hôpital Jean Minjoz
City
Besançon
ZIP/Postal Code
25000
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bontemps Patrick, MD
Facility Name
ONCODOC
City
Béziers
ZIP/Postal Code
34500
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Levecq Jean-Marc, MD
Facility Name
Centre d'Oncologie et de Radiothérapie du Parc
City
Chalon-sur-Saône
ZIP/Postal Code
71100
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Schipman Benjamin, MD
Facility Name
Clinique du Parc de Charleville-Mézières
City
Charleville-Mézières
ZIP/Postal Code
08000
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonveaux Eric, MD
Facility Name
CLCC Jean Perrin
City
Clermont Ferrand
ZIP/Postal Code
63000
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Belliere-Calandry Aurélie, MD
Facility Name
Hôpitaux Civils de Colmar
City
Colmar
ZIP/Postal Code
68000
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boutenbat Ghizlane, MD
Facility Name
Centre Georges-François Leclerc
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peignaux Karine, MD
Facility Name
Institut Daniel Hollard
City
Grenoble
ZIP/Postal Code
38000
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claeys Marie-Virginie, MD
Facility Name
CHU de Grenoble, Hôpital A.Michallon
City
La Tronche
ZIP/Postal Code
38700
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gabelle - Flandin Isabelle, MD
Facility Name
CHR Metz-Thionville Hôpital de Mercy
City
Metz
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Quetin Philippe, MD
Facility Name
CH de Belfort-Montbéliard Site du Mittan
City
Montbéliard
ZIP/Postal Code
25200
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boulbair Fatiha, MD
Facility Name
CH de Mulhouse
City
Mulhouse
ZIP/Postal Code
68100
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Grandgirard Alain, MD
Facility Name
Centre d'Oncologie de Gentilly
City
Nancy
ZIP/Postal Code
54100
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marquis Isabelle, MD
Facility Name
CHU de Poitiers
City
Poitiers
ZIP/Postal Code
86000
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
El Hajj Labib, MD
Facility Name
Institut Jean Godinot de Reims
City
Reims
ZIP/Postal Code
51100
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guilbert Philippe, MD
Facility Name
CLCC Saint Etienne
City
Saint-Priest en Jarez
ZIP/Postal Code
42270
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Magné Nicolas, MD
Facility Name
Centre Paul Strauss
City
Strasbourg
ZIP/Postal Code
67000
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Salze Pierre, MD
Facility Name
Clinique de l'Orangerie
City
Strasbourg
ZIP/Postal Code
67000
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karst Anne, MD
Facility Name
Institut Universitaire du Cancer
City
Toulouse
ZIP/Postal Code
31000
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Massabeau Carole, MD
Facility Name
CH de Troyes
City
Troyes
ZIP/Postal Code
10000
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Beaumont Claudine, MD
Facility Name
Institut de Cancérologie de Lorraine
City
Vandoeuvre-les-Nancy
ZIP/Postal Code
54519
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
VOGIN Guillaume, MD
Email
g.vogin@nancy.unicancer.fr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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