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A Phase II Study Designed to Evaluate the Value of Alkagin Paste in the Prevention of Radiation Dermatitis for Patients Undergoing External Radiation Therapy


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Anus Neoplasms, Rectal Neoplasms, Urogenital Neoplasms

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Trial Information

A Phase II Study Designed to Evaluate the Value of Alkagin Paste in the Prevention of Radiation Dermatitis for Patients Undergoing External Radiation Therapy


Inclusion Criteria:



- Patients receiving a dose of 45 Gy or more with concomitant chemotherapy to the
perineal skin (for treatment of anal canal, low rectal or gynecological cancer).

- Patients able to understand and sign an informed consent form.

- Patients that do not have active connective tissue disorders.

- Patients 18 years or older.

- Patients that did not receive any previous radiation.

- Patients that do not have any known allergy to any ingredients of the Alkagin Paste

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

- Patients who have been offered to purchase silver clear underpants but have refused

Exclusion Criteria:

- Patients that have a type V or type VI 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 I (scores 0-7) White; very fair; freckles. Always burns, never tans

- Type II (scores 8-16) White; fair. Usually burns, tans with difficulty

- Type III (scores 17-25) Beige; very common. Sometimes mild burn, gradually tans

- Type IV (scores 25-30) Beige with a brown tint; typical Mediterranean Caucasian skin.
Rarely burns, tans with ease

- Type V (scores over 30) Dark brown. Very rarely burns, tans very easily

- Type VI Black. Never burns, tans very easily

2) Patients with an allergic reaction to Alkagin Paste

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 Alkagin Paste compared to patients treated with institutional standard skin care.

Outcome Time Frame:

7 weeks post beginning of radiation treatments

Safety Issue:

Yes

Principal Investigator

Te Vuong, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Jewish General Hospital

Authority:

Canada: Research Ethics Office

Study ID:

11-052

NCT ID:

NCT01408407

Start Date:

December 2011

Completion Date:

December 2014

Related Keywords:

  • Anus Neoplasms
  • Rectal Neoplasms
  • Urogenital Neoplasms
  • Patients with anal canal, low rectal or gynecological cancer
  • Anus Neoplasms
  • Neoplasms
  • Dermatitis
  • Radiodermatitis
  • Rectal Neoplasms
  • Urogenital Neoplasms

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