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

NCT02898376 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 142

Last updated 2018-08-08

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Association Francaise pour la Recherche Thermale

    collaborator OTHER

  • Institut de Cancérologie de Lorraine

    lead OTHER

Principal Investigators

  • VOGIN Guillaume, MD,PhD · Institut de Cancérologie de Lorraine

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-31
Primary Completion
2020-07-31
Completion
2021-12-31

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02898376 on ClinicalTrials.gov