Prophylactic Topical Agents in Reducing Radiation-Induced Dermatitis in Patients With Non-inflammatory Breast Cancer

Phase 2

Completed

• Conditions: Breast Carcinoma; Stage 0 Breast Cancer; Pain; Radiation-Induced Dermatitis
• Interventions: Drug: Curcumin-based Gel; Procedure: Dermatologic Complications Management; Other: Laboratory Biomarker Analysis; Other: Placebo; Other: Questionnaire Administration

• Registration Number: NCT02556632
• Lead Sponsor: Gary Morrow

Brief Summary

This randomized pilot phase II trial studies and compares prophylactic topical agents in reducing radiation-induced dermatitis in patients with non-inflammatory breast cancer or breast cancer in situ. The prophylactic topical agents, such as curcumin-based gel or HPR Plus, may reduce the severity of the radiation-induced dermatitis by minimizing water loss and inflammation during radiation therapy.

Detailed Description

PRIMARY OBJECTIVE:

I. To investigate the effectiveness of Curcumin gel (curcumin-based gel) or HPR Plus™ in reducing radiation dermatitis in breast cancer patients.

Study Timeline

• Study First Submitted: 2015-07-23
• Study First Submitted QC: 2015-09-18
• Study First Posted: 2015-09-22
• Study Start: 2015-10-13
• Primary Completion: 2016-09-30
• Study Completion: 2016-09-30
• Results First Submitted: 2017-08-28
• Status Verified: 2017-10
• Results First Submitted QC: 2017-10-04
• Last Update Submitted: 2017-10-04
• Results First Posted: 2017-11-06
• Last Update Posted: 2017-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 191

Inclusion Criteria

• Subjects with a diagnosis of non-inflammatory breast cancer or carcinoma in situ

• Subjects must be prescribed and scheduled for "conventional fractionated" RT without concurrent chemotherapy; bolus and intensity modulated radiation therapy (IMRT) are permitted; lymph node irradiation (i.e., internal mammary nodes, supraclavicular nodes, axillary nodes, etc) as part of their prescribed radiation therapy are permitted; conventional fractionated radiation therapy regimens eligible for study are described below:

  • Minimal (min) total dose: whole breast: 44 gray (Gy); breast boost: 10 Gy; tumor bed = whole breast +/- boost: 50.0 Gy; lymph nodes: 45 Gy
  • Maximal (max) total dose: whole breast: 50.4 Gy; breast boost: 20 Gy; tumor bed = whole breast +/- boost: 66.0 Gy; lymph nodes: 50.4 Gy
  • Min dose per fraction: whole breast: 1.8 Gy; breast boost: 2.0 Gy; tumor bed = whole breast +/- boost: 1.8 Gy; lymph nodes: 1.8 Gy
  • Max dose per fraction: whole breast: 2.0 Gy; breast boost: 2.0 Gy; tumor bed = whole breast +/- boost: 2.0 Gy; lymph nodes: 2.0 Gy
  • Min # of fractions: whole breast: 22 Gy; breast boost: 5 Gy; tumor bed = whole breast +/- boost: 25 Gy; lymph nodes: 25 Gy
  • Max # of fractions: whole breast: 28 Gy; breast boost: 10 Gy; tumor bed = whole breast +/- boost: 36 Gy; lymph nodes: 28 Gy
  • Min # of sessions: whole breast: 22 Gy; breast boost: 5 Gy; tumor bed = whole breast +/- boost: 25 Gy; lymph nodes: 25 Gy
  • Max # of sessions: whole breast: 28 Gy; breast boost: 10 Gy; tumor bed = whole breast +/- boost: 36 Gy; lymph nodes: 28 Gy

• Subjects may or may not have had surgery (lumpectomy or mastectomy) prior to RT; (NOTE: surgery is not required for eligibility)

• Subjects may have had chemotherapy prior to radiation; a minimum of two weeks is required between end of chemotherapy and start of RT

• Subjects may be currently prescribed hormone treatment or Herceptin therapy

• Subjects must be able to read, speak, and understand English

• Subjects must have the ability to understand and the willingness to sign a written informed consent document

• Subjects must agree to not use any other topical agents on skin in the radiation treatment area during the course of this trial; subjects should only use topical agents for the study (i.e., topical intervention or standard care agents) supplied by the study personnel and/or treating physician

Read More

Exclusion Criteria

• Pregnant females are ineligible; all subjects of childbearing potential will be asked if they are pregnant or could be pregnant; the patient must respond "no" to continue with radiation and to participate in this clinical study
• Subjects with bilateral breast cancer are not eligible
• Subjects receiving the short-course fractionation radiation therapy (i.e., 16 sessions or 20 sessions at 2.4 to 2.6 Gy fractions per session, with or without boost)
• Subject is currently on anti-EGFR (human epidermal growth factor receptor) therapy, such as Iressa (gefitinib) or Erbitux (cetuximab, C225)
• Previous radiation to the chest or breast
• Subjects with breast reconstruction prior to RT
• Previous diagnosis of radiosensitivity disorder (i.e., ataxia telangiectasia)
• Previous diagnosis of collagen vascular disorder or vasculitis
• Presence of unhealed surgical wounds in chest or breast region and/or breast infection
• Current daily application of a prescribed topical product to the skin within the RT area for an unrelated skin condition that cannot be discontinued during the participation in this clinical trial
• Presence of any active dermatological issues in radiation treatment area (i.e., fungal skin infection, dermatitis, psoriasis plaques, etc)

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm I (curcumin-based gel)	Curcumin-based Gel	Patients apply curcumin-based gel topically TID approximately every 4-6 hours beginning on the first day of radiation therapy and continuing until 1 week after completion of radiation therapy.
Arm I (curcumin-based gel)	Laboratory Biomarker Analysis	Patients apply curcumin-based gel topically TID approximately every 4-6 hours beginning on the first day of radiation therapy and continuing until 1 week after completion of radiation therapy.
Arm I (curcumin-based gel)	Questionnaire Administration	Patients apply curcumin-based gel topically TID approximately every 4-6 hours beginning on the first day of radiation therapy and continuing until 1 week after completion of radiation therapy.
Arm II (HPR Plus)	Dermatologic Complications Management	Patients apply HPR Plus™ topically TID approximately every 4-6 hours beginning on the first day of radiation therapy and continuing until 1 week after completion of radiation therapy.
Arm II (HPR Plus)	Laboratory Biomarker Analysis	Patients apply HPR Plus™ topically TID approximately every 4-6 hours beginning on the first day of radiation therapy and continuing until 1 week after completion of radiation therapy.
Arm II (HPR Plus)	Questionnaire Administration	Patients apply HPR Plus™ topically TID approximately every 4-6 hours beginning on the first day of radiation therapy and continuing until 1 week after completion of radiation therapy.
Arm III (placebo gel)	Laboratory Biomarker Analysis	Patients apply placebo gel topically TID approximately every 4-6 hours beginning on the first day of radiation therapy and continuing until 1 week after completion of radiation therapy.
Arm III (placebo gel)	Placebo	Patients apply placebo gel topically TID approximately every 4-6 hours beginning on the first day of radiation therapy and continuing until 1 week after completion of radiation therapy.
Arm III (placebo gel)	Questionnaire Administration	Patients apply placebo gel topically TID approximately every 4-6 hours beginning on the first day of radiation therapy and continuing until 1 week after completion of radiation therapy.

Primary Outcome Measures

Name	Time	Method
Mean Radiation Dermatitis Severity (RDS) Score. Range: 0 (no Dermatitis) - 4 (Violaceous Erythema With Diffuse Desquamation Occurring in Sheets; Patchy Crusting; Superficial Ulceration)	Baseline up to 1 week post radiation therapy	The mean 1 week post-RT RDS score for each arm will be compared using ANOVA to determine if the topical interventions reduce the severity of skin reactions at the end of RT.; The RDS score ranges from 0-4 with higher scores indicating worse outcome.
Incidence of Moist Desquamation (Present vs. Absent)	Baseline up to completion of radiation therapy	The degree to which each topical intervention decreases the incidence of moist desquamation will be examined using Fisher's exact test. Each agent's potential as a preventative intervention will be determined through comparison of the proportion of subjects with no to minimal radiation dermatitis within each arm using Fisher's exact test.
Change in the Severity of Skin Reactions Using the Radiation Dermatitis Scale (RDS). Range: 0 (no Dermatitis) - 4 (Violaceous Erythema With Diffuse Desquamation Occurring in Sheets; Patchy Crusting; Superficial Ulceration)	Baseline to up to 1 week after completion of radiation therapy	The mean 1 week post-RT RDS score for each arm will be compared using ANOVA to determine if the topical interventions reduce the severity of skin reactions after completion of RT.; The RDS score ranges from 0-4 with higher scores indicating worse outcome.

Trial Locations

Locations (6)

Metro-Minnesota NCORP; 🇺🇸 Minneapolis, Minnesota, United States

University of Rochester; 🇺🇸 Rochester, New York, United States

Delaware/Christiana Care NCORP; 🇺🇸 Newark, Delaware, United States

Heartland NCORP; 🇺🇸 Decatur, Illinois, United States

Columbus NCORP; 🇺🇸 Columbus, Ohio, United States

Dayton Oncology Research Program; 🇺🇸 Dayton, Ohio, United States