Laser Therapy for the Management of Radiation Dermatitis
Raktažodžiai
Santrauka
Datos
Paskutinį kartą patikrinta: | 11/30/2014 |
Pirmasis pateikimas: | 08/26/2013 |
Numatytas registravimas pateiktas: | 08/26/2013 |
Pirmas paskelbtas: | 08/29/2013 |
Paskutinis atnaujinimas pateiktas: | 12/02/2014 |
Paskutinis atnaujinimas paskelbtas: | 12/03/2014 |
Faktinė studijų pradžios data: | 07/31/2013 |
Numatoma pirminio užbaigimo data: | 06/30/2014 |
Numatoma studijų užbaigimo data: | 06/30/2014 |
Būklė ar liga
Intervencija / gydymas
Device: Treatment Group
Fazė
Rankų grupės
Ranka | Intervencija / gydymas |
---|---|
No Intervention: Control Group Receives institutional skin care protocol | |
Experimental: Treatment Group Receives institutional skin care protocol and, when applicable (if skin reactions develop), Low-Level Laser Therapy | Device: Treatment Group Low-Level Laser Therapy will be applied, twice a week, from the moment skin reactions become painful until skin reactions are no longer painful |
Tinkamumo kriterijai
Tinkamos studijoms lytys | Female |
Priima sveikus savanorius | Taip |
Kriterijai | Inclusion Criteria: - Diagnosis of noninvasive (Stage 0) or invasive (Stages 1, 2 or 3A) breast adenocarcinoma - Treatment with primary breast-sparing surgery (lumpectomy) and/ or neoadjuvant (preoperative) or adjuvant (postoperative) chemotherapy or hormonal treatment - Scheduled for postoperative radiotherapy with standard technique (isocentric) and fractionation regime (i.e., 25 daily fractions to the whole breast followed by a boost of 8 fractions to the tumor bed, 2 Gy per fraction, five times per week) - Provide signed informed consent Exclusion Criteria: - Previous irradiation to the same breast - Metastatic disease - Mastectomy surgery - Concurrent chemo-radiotherapy - Required use of bolus material to deliver radiation therapy (i.e., material placed on the to-be-irradiated zone to modulate the delivered dose in order to ensure an optimal distribution of the radiation dose) |
Rezultatas
Pirminės rezultatų priemonės
1. Radiation Dermatitis Grade [3 months (during radiation therapy and one month after)]
2. Radiation Dermatitis Assessment [3 months (during radiation therapy and one month after)]
3. Pain [3 months (during radiation therapy and one month after)]
Antrinės rezultatų priemonės
1. Quality of Life [3 months (during radiation therapy and one month after)]
2. Impact of Radiation Dermatitis [3 months (during radiation therapy and one month after)]
3. Satisfaction with therapy [3 months (during radiation therapy and one month after)]
Kitos rezultato priemonės
1. Moist desquamation [6.5 weeks (during radiation therapy)]