Prophylactic Topical Agents in Reducing Radiation-Induced Dermatitis in Patients With Non-inflammatory Breast Cancer (Curcumin-II)

Gary Morrow

Status and phase: Completed; Phase 2

Conditions: Radiation-Induced Dermatitis; Breast Carcinoma; Pain; Stage 0 Breast Cancer

Treatments: Drug: Curcumin-based Gel; Procedure: Dermatologic Complications Management; Other: Laboratory Biomarker Analysis; Other: Questionnaire Administration; Other: Placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02556632

URCC14079 (Other Identifier)

UG1CA189961 (U.S. NIH Grant/Contract)

R21CA178648 (U.S. NIH Grant/Contract)

URCC-14079 (Other Identifier)

NCI-2015-00869 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 191 patients

Sex: Female

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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191 participants in 3 patient groups, including a placebo group

Arm I (curcumin-based gel)

Experimental group

Description:

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.

Treatment:

Drug: Curcumin-based Gel

Other: Laboratory Biomarker Analysis

Other: Questionnaire Administration

Arm II (HPR Plus)

Experimental group

Description:

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.

Treatment:

Other: Laboratory Biomarker Analysis

Other: Questionnaire Administration

Procedure: Dermatologic Complications Management

Arm III (placebo gel)

Placebo Comparator group

Description:

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.

Treatment:

Other: Placebo

Other: Laboratory Biomarker Analysis

Other: Questionnaire Administration