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A Phase II Study Designed to Evaluate the Value of Neoviderm Skin Emulsion in the Prevention of Radiation Dermatitis for Patients Undergoing External Radiation Therapy


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Breast Cancer, Head and Neck Cancer

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Trial Information

A Phase II Study Designed to Evaluate the Value of Neoviderm Skin Emulsion in the Prevention of Radiation Dermatitis for Patients Undergoing External Radiation Therapy


Inclusion Criteria:



- Patients with breast cancer receiving a dose of at least 50Gy in 25 fractions with
concomitant chemotherapy or treated with the McGill technique

- Patients with head and neck cancer receiving radiotherapy on fields that include both
sides of the neck

- Patients able to understand and sign an informed consent form

- Patients that do not have active connective tissue disorders

- Patients 18 years old or older

- Patients that did not receive any previous radiation

- Patients that do not have any known allergy to any ingredients of the Neoviderm cream

- Patients need to be able to apply the creams themselves or have help with applying
the creams

Exclusion Criteria:

- Patients that have a type V or type IV skin type according to the Fitzpatrick
scale(because these patients will likely have less radiodermatitis and if they do, it
will be harder to evaluate it).

- The Fitzpatrick Scale: Type 1

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Maximum skin toxicity

Outcome Description:

The objective of this study is to determine the occurrence and degree of acute skin toxicity in patients receiving radical radiation therapy with preventive application of neoviderm compared to patients treated with institutional standard skin care.

Outcome Time Frame:

7 weeks post beginning of radiation treatments

Safety Issue:

Yes

Authority:

Canada: Canadian Institutes of Health Research

Study ID:

11-135

NCT ID:

NCT01470872

Start Date:

December 2011

Completion Date:

December 2012

Related Keywords:

  • Breast Cancer
  • Head and Neck Cancer
  • Breast Neoplasms
  • Dermatitis
  • Head and Neck Neoplasms
  • Radiodermatitis

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