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Breast CarcinomaPhase 3FIBROTHERMENCT02898376

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

A Phase 3 study testing skin-oriented spa care, Pentoxifylline and Tocopherol acetate in people with Breast Carcinoma and Fibrosis, run by Institut de Cancérologie de Lorraine at 21 sites in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 80 years, women only
Conditions the study is for
Breast Carcinoma, Fibrosis
What is being tested?
skin-oriented spa care, Pentoxifylline and Tocopherol acetate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
142 participants
Where
21 sitesFrance
Study dates
Dec 2018to Dec 2021
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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

Who cannot join

  • 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
Show all 22Show fewer
  • 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

Trial locations and contacts

21 sites in 1 country.

MERLIN Jean Louis contact

0033383598307

jl.merlin@nancy.unicancer.fr

FERNANDES Laurinda contact

0033383598487

l.fernandes@nancy.unicancer.fr

21 sites in 1 country

France21 sites

  • CHU de Besançon Hôpital Jean Minjoz

    Besançon, 25000

    Bontemps Patrick, MD

  • ONCODOC

    Béziers, 34500

    Levecq Jean-Marc, MD

  • Centre d'Oncologie et de Radiothérapie du Parc

    Chalon-sur-Saône, 71100

    Schipman Benjamin, MD

  • Clinique du Parc de Charleville-Mézières

    Charleville-Mézières, 08000

    Jonveaux Eric, MD

  • CLCC Jean Perrin

    Clermont-Ferrand, 63000

    Belliere-Calandry Aurélie, MD

  • Hôpitaux Civils de Colmar

    Colmar, 68000

    Boutenbat Ghizlane, MD

  • Centre Georges-François Leclerc

    Dijon, 21079

    Peignaux Karine, MD

  • Institut Daniel Hollard

    Grenoble, 38000

    Claeys Marie-Virginie, MD

  • CHU de Grenoble, Hôpital A.Michallon

    La Tronche, 38700

    Gabelle - Flandin Isabelle, MD

  • CHR Metz-Thionville Hôpital de Mercy

    Metz

    Quetin Philippe, MD

  • CH de Belfort-Montbéliard Site du Mittan

    Montbéliard, 25200

    Boulbair Fatiha, MD

  • CH de Mulhouse

    Mulhouse, 68100

    Grandgirard Alain, MD

  • Centre d'Oncologie de Gentilly

    Nancy, 54100

    Marquis Isabelle, MD

  • CHU de Poitiers

    Poitiers, 86000

    El Hajj Labib, MD

  • Institut Jean Godinot de Reims

    Reims, 51100

    Guilbert Philippe, MD

  • CLCC Saint Etienne

    Saint-Priest-en-Jarez, 42270

    Magné Nicolas, MD

  • Centre Paul Strauss

    Strasbourg, 67000

    Salze Pierre, MD

  • Clinique de l'Orangerie

    Strasbourg, 67000

    Karst Anne, MD

  • Institut Universitaire du Cancer

    Toulouse, 31000

    Massabeau Carole, MD

  • CH de Troyes

    Troyes, 10000

    Beaumont Claudine, MD

  • Institut de Cancérologie de Lorraine

    Vandœuvre-lès-Nancy, 54519

    VOGIN Guillaume, MD, g.vogin@nancy.unicancer.fr

Other trials in France

About this study

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

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.

Read the 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.

Being tested
skin-oriented spa care, Pentoxifylline, Tocopherol acetate
Keywords
spa care, randomised controlled trial, pentoxifylline/tocopherol combination, late sequelae, radiotherapy
Medical subject headings
Breast Neoplasms, Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • skin-oriented spa careOther

    standardized procedure : 72 care sessions over 18 days of treatment

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

  • PentoxifyllineDrug

    400 mg bid during at least 6 months

  • Tocopherol acetateDrug

    500 mg bid during at least 6 months

Study groups in NCT02898376
Study groupRoleWhat they receive
combination tocopherol/pentoxifylline + spa careExperimentalpentoxifylline (400 mg bid) + tocopherol (500 mg x bid) during at least 6 months AND skin-oriented spa care (18 days)
Receives: Other: skin-oriented spa care; Drug: Pentoxifylline; Drug: Tocopherol acetate
combination tocopherol/pentoxifyllineActive comparatorpentoxifylline (400 mg bid) + tocopherol (500 mg x bid) during at least 6 months
Receives: Drug: Pentoxifylline; Drug: Tocopherol acetate

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 6 months after the end of treatment

Secondary outcomes (6)

  1. 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.

    Measured: 12 months after the end of treatment

  2. Overall quality of life

    quality of life questionnaire (EORTC QLQ C30 score)

    Measured: 6 months

  3. Breast-oriented quality of life

    EORTC QLQ-BR23 score

    Measured: 6 months

  4. 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

    Measured: 6 months

  5. 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

    Measured: 6 months

  6. 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

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Sep 2016 (estimated)
  2. Study startDec 2018 (estimated)
  3. Primary completionJul 2020 (estimated)
  4. Study completionDec 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
142 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02898376
Sponsor's protocol ID
2016-003518-28
Other IDs
2016
Acronym
FIBROTHERME
Status last verified
Aug 2018
First submitted
8 Sep 2016
Last updated
8 Aug 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing skin-oriented spa care, Pentoxifylline and Tocopherol acetate in people with Breast Carcinoma and Fibrosis, run by Institut de Cancérologie de Lorraine at 21 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 8 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact MERLIN Jean Louis (0033383598307, jl.merlin@nancy.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dermatology Quality of life at 6 months (time frame: 6 months after the end of treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02898376.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2018.

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