Alkagin Paste in the Prevention of Radiation Dermatitis

NCT ID: NCT01408407

Last Updated: 2015-05-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31

Brief Summary

The purpose of this study is to determine whether Alkagin paste is effective at preventing radiodermatitis in patients receiving external beam radiation therapy to the perineal area.

Conditions

Anus Neoplasms; Rectal Neoplasms; Urogenital Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Arm A: standard of care

Patients will be asked to apply Aveeno cream twice a day starting the day of their treatment until two weeks after the end of their treatment

Group Type: ACTIVE_COMPARATOR

Aveeno cream

Intervention Type: OTHER

Apply cream on irradiated area twice a day

Arm B: standard of care plus Alkagin paste

Patients will apply Alkagin Paste to the treatment area everyday one week before starting radiotherapy, throughout treatment and for two weeks post treatment. They will also perform standard of care skin treatment.

Group Type: EXPERIMENTAL

Aveeno cream

Intervention Type: OTHER

Apply cream on irradiated area twice a day

Alkagin paste

Intervention Type: OTHER

Apply Alkagin paste three times a day.

Interventions

Aveeno cream

Apply cream on irradiated area twice a day

Intervention Type: OTHER

Alkagin paste

Apply Alkagin paste three times a day.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Avario Healthcare Inc.

INDUSTRY

Sponsor Role: collaborator

Dr. Te Vuong

OTHER

Sponsor Role: lead

Responsible Party

Dr. Te Vuong

MD-Director Radiation Oncology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Te Vuong, MD

Role: PRINCIPAL_INVESTIGATOR

Jewish General Hospital

Locations

Jewish General Hospital

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

11-052

Identifier Type: -

Identifier Source: org_study_id