NCT01408407

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 2, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 3, 2011

Completed
4 months until next milestone

Study Start

First participant enrolled

December 1, 2011

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Last Updated

May 25, 2015

Status Verified

May 1, 2015

Enrollment Period

2.4 years

First QC Date

August 2, 2011

Last Update Submit

May 22, 2015

Conditions

Anus NeoplasmsRectal NeoplasmsUrogenital Neoplasms

Keywords

Patients with anal canal, low rectal or gynecological cancer

Outcome Measures

Primary Outcomes (1)

  • Maximum skin toxicity

    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.

    7 weeks post beginning of radiation treatments

Study Arms (2)

Arm A: standard of care

ACTIVE COMPARATOR

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

Arm B: standard of care plus Alkagin paste

EXPERIMENTAL

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 creamOther: Alkagin paste

Interventions

Aveeno creamOTHER

Apply cream on irradiated area twice a day

Arm A: standard of careArm B: standard of care plus Alkagin paste
Alkagin pasteOTHER

Apply Alkagin paste three times a day.

Arm B: standard of care plus Alkagin paste

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • \) Patients with an allergic reaction to Alkagin Paste

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

MeSH Terms

Conditions

Anus NeoplasmsRectal NeoplasmsUrogenital Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesAnus DiseasesRectal DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Te Vuong, MD

    Jewish General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD-Director Radiation Oncology

Study Record Dates

First Submitted

August 2, 2011

First Posted

August 3, 2011

Study Start

December 1, 2011

Primary Completion

May 1, 2014

Last Updated

May 25, 2015

Record last verified: 2015-05

Locations

CA(1)