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Laser Therapy for the Management of Radiation Dermatitis

Straipsnius versti gali tik registruoti vartotojai
Prisijungti Registracija
Nuoroda įrašoma į mainų sritį
StatusasBaigta
Rėmėjai
Hasselt University

Raktažodžiai

Santrauka

Low Level Laser Therapy (LLLT) is a form of phototherapy which involves the application of light to injuries and lesions to promote tissue regeneration. It is a noninvasive treatment modality based on the photochemical effect of light on tissues, which modulates various metabolic processes.
LLLT has been used for a wide range of conditions, in particular in dermatology, to promote wound healing, reduce inflammation and oedema, and relieve pain. In this study, we intend to assess the efficacy of LLLT to manage radiotherapy-induced skin reactions (or radiation dermatitis), a very common and distressing side effect of cancer treatment.

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

Radiation Dermatitis

Intervencija / gydymas

Device: Treatment Group

Fazė

-

Rankų grupės

RankaIntervencija / 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 lytysFemale
Priima sveikus savanoriusTaip
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)]

objective scoring of the severity of radiation dermatitis using the grading system of the Radiation Therapy Oncology Group/ European Organization for Research and Treatment of Cancer (RTOG/ EORTC).

2. Radiation Dermatitis Assessment [3 months (during radiation therapy and one month after)]

Radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS)

3. Pain [3 months (during radiation therapy and one month after)]

evaluation of pain using a visual analogue scale

Antrinės rezultatų priemonės

1. Quality of Life [3 months (during radiation therapy and one month after)]

Health-related quality of life measure specific to skin diseases (Skindex-16)

2. Impact of Radiation Dermatitis [3 months (during radiation therapy and one month after)]

Self-report on the impact of radiation dermatitis on daily activities

3. Satisfaction with therapy [3 months (during radiation therapy and one month after)]

Self-report on the efficacy of and the global satisfaction with the management of radiation dermatitis

Kitos rezultato priemonės

1. Moist desquamation [6.5 weeks (during radiation therapy)]

Onset time of moist desquamation

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