Laser Therapy for the Management of Radiation Dermatitis

Watumiaji waliosajiliwa tu ndio wanaweza kutafsiri nakala

Ingia / Ingia

Kiungo kimehifadhiwa kwenye clipboard

HaliImekamilika

Wadhamini

Hasselt University

JARIBIO LA KLINIKI: NCT01932073

BioSeek: NCT01932073

Maneno muhimu

Kikemikali

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.

Tarehe

Imethibitishwa Mwisho:	11/30/2014
Iliyowasilishwa Kwanza:	08/26/2013
Uandikishaji uliokadiriwa Uliwasilishwa:	08/26/2013
Iliyotumwa Kwanza:	08/29/2013
Sasisho la Mwisho Liliwasilishwa:	12/02/2014
Sasisho la Mwisho Lilichapishwa:	12/03/2014
Tarehe halisi ya kuanza kwa masomo:	07/31/2013
Tarehe ya Kukamilisha Msingi iliyokadiriwa:	06/30/2014
Tarehe ya Kukamilisha Utafiti:	06/30/2014

Hali au ugonjwa

Radiation Dermatitis

Uingiliaji / matibabu

Device: Treatment Group

Awamu

Vikundi vya Arm

Mkono	Uingiliaji / matibabu
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

Vigezo vya Kustahiki

Jinsia Inastahiki Kujifunza

Female

Hupokea Wajitolea wa Afya

Ndio

Vigezo

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)

Matokeo

Hatua za Matokeo ya Msingi

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

Hatua za Matokeo ya Sekondari

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

Hatua Nyingine za Matokeo

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

Onset time of moist desquamation