Alkagin Paste in the Prevention of Radiation Dermatitis

Sponsor

Dr. Te Vuong (Other)

Overall Status

Terminated

CT.gov ID

NCT01408407

Collaborator

Avario Healthcare Inc. (Industry)

Enrollment

Location

Arms

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anus Neoplasms Rectal Neoplasms Urogenital Neoplasms	Other: Aveeno cream Other: Alkagin paste	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

2 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Dec 1, 2011

Actual Primary Completion Date :

May 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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	Other: Aveeno cream Apply cream on irradiated area twice a day
Experimental: 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.	Other: Aveeno cream Apply cream on irradiated area twice a day Other: Alkagin paste Apply Alkagin paste three times a day.

Arm

Intervention/Treatment

Active Comparator: 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

Other: Aveeno cream

Apply cream on irradiated area twice a day

Experimental: 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.

Other: Aveeno cream

Apply cream on irradiated area twice a day

Other: Alkagin paste

Apply Alkagin paste three times a day.

Outcome Measures

Primary Outcome Measures

Maximum skin toxicity [7 weeks post beginning of radiation treatments]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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