ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02898376
Recruitment Status : Not yet recruiting
First Posted : September 13, 2016
Last Update Posted : April 17, 2018
Sponsor:
Collaborator:
Association Francaise pour la Recherche Thermale
Information provided by (Responsible Party):
Institut de Cancérologie de Lorraine

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.

Condition or disease Intervention/treatment Phase
Breast Carcinoma Fibrosis Other: skin-oriented spa care Drug: Pentoxifylline Drug: Tocopherol acetate Phase 3

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 142 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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
Estimated Study Start Date : July 2018
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : December 2021


Arm Intervention/treatment
Experimental: 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)
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

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

Active Comparator: combination tocopherol/pentoxifylline
pentoxifylline (400 mg bid) + tocopherol (500 mg x bid) during at least 6 months
Drug: Pentoxifylline
400 mg bid during at least 6 months

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




Primary Outcome Measures :
  1. Dermatology Quality of life at 6 months [ Time Frame: 6 months after the end of treatment ]
    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 :
  1. Dermatology Quality of life at 12 months [ Time Frame: 12 months after the end of treatment ]
    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.

  2. Overall quality of life [ Time Frame: 6 months ]
    quality of life questionnaire (EORTC QLQ C30 score)

  3. Breast-oriented quality of life [ Time Frame: 6 months ]
    EORTC QLQ-BR23 score

  4. late radiation toxicity [ Time Frame: 6 months ]
    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

  5. Skin thickness [ Time Frame: 6 months ]
    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. Cosmetic appearance [ Time Frame: 6 months ]
    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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02898376


Contacts
Contact: MERLIN Jean Louis 0033383598307 jl.merlin@nancy.unicancer.fr
Contact: FERNANDES Laurinda 0033383598487 l.fernandes@nancy.unicancer.fr

Locations
France
CHU de Besançon Hôpital Jean Minjoz Not yet recruiting
Besançon, France, 25000
Contact: Bontemps Patrick, MD         
ONCODOC Not yet recruiting
Béziers, France, 34500
Contact: Levecq Jean-Marc, MD         
Centre d'Oncologie et de Radiothérapie du Parc Not yet recruiting
Chalon-sur-Saône, France, 71100
Contact: Schipman Benjamin, MD         
Clinique du Parc de Charleville-Mézières Not yet recruiting
Charleville-Mézières, France, 08000
Contact: Jonveaux Eric, MD         
CLCC Jean Perrin Not yet recruiting
Clermont Ferrand, France, 63000
Contact: Belliere-Calandry Aurélie, MD         
Hôpitaux Civils de Colmar Not yet recruiting
Colmar, France, 68000
Contact: Boutenbat Ghizlane, MD         
Centre Georges-François Leclerc Not yet recruiting
Dijon, France, 21079
Contact: Peignaux Karine, MD         
Institut Daniel Hollard Not yet recruiting
Grenoble, France, 38000
Contact: Claeys Marie-Virginie, MD         
CHU de Grenoble, Hôpital A.Michallon Not yet recruiting
La Tronche, France, 38700
Contact: Gabelle - Flandin Isabelle, MD         
CHR Metz-Thionville Hôpital de Mercy Not yet recruiting
Metz, France
Contact: Quetin Philippe, MD         
CH de Belfort-Montbéliard Site du Mittan Not yet recruiting
Montbéliard, France, 25200
Contact: Boulbair Fatiha, MD         
CH de Mulhouse Not yet recruiting
Mulhouse, France, 68100
Contact: Grandgirard Alain, MD         
Centre d'Oncologie de Gentilly Not yet recruiting
Nancy, France, 54100
Contact: Marquis Isabelle, MD         
CHU de Poitiers Not yet recruiting
Poitiers, France, 86000
Contact: El Hajj Labib, MD         
Institut Jean Godinot de Reims Not yet recruiting
Reims, France, 51100
Contact: Guilbert Philippe, MD         
CLCC Saint Etienne Not yet recruiting
Saint-Priest en Jarez, France, 42270
Contact: Magné Nicolas, MD         
Centre Paul Strauss Not yet recruiting
Strasbourg, France, 67000
Contact: Salze Pierre, MD         
Clinique de l'Orangerie Not yet recruiting
Strasbourg, France, 67000
Contact: Karst Anne, MD         
Institut Universitaire du Cancer Not yet recruiting
Toulouse, France, 31000
Contact: Massabeau Carole, MD         
CH de Troyes Not yet recruiting
Troyes, France, 10000
Contact: Beaumont Claudine, MD         
Institut de Cancérologie de Lorraine Not yet recruiting
Vandoeuvre-les-Nancy, France, 54519
Contact: VOGIN Guillaume, MD       g.vogin@nancy.unicancer.fr   
Sponsors and Collaborators
Institut de Cancérologie de Lorraine
Association Francaise pour la Recherche Thermale
Investigators
Principal Investigator: VOGIN Guillaume, MD,PhD Institut de Cancérologie de Lorraine

Responsible Party: Institut de Cancérologie de Lorraine
ClinicalTrials.gov Identifier: NCT02898376     History of Changes
Other Study ID Numbers: 2016-003518-28
First Posted: September 13, 2016    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Institut de Cancérologie de Lorraine:
spa care
randomised controlled trial
pentoxifylline/tocopherol combination
late sequelae
radiotherapy

Additional relevant MeSH terms:
Fibrosis
Breast Neoplasms
Pathologic Processes
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Pentoxifylline
Tocopherols
Vitamin E
Tocotrienols
alpha-Tocopherol
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs
Vasodilator Agents
Free Radical Scavengers
Antioxidants
Vitamins
Micronutrients
Growth Substances