Symptoms and General Pathology

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Wounds and Injuries

Rare Diseases

Recurrence

Carcinoma

Breast Neoplasms

Carcinoma in Situ

Dermatitis

Neoplasm Metastasis

Carcinoma, Ductal

Breast Neoplasms, Male

Breast Carcinoma In Situ

Carcinoma, Intraductal, Noninfiltrating

Carcinoma, Ductal, Breast

Radiodermatitis

Breast Diseases

Skin Diseases

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Radiation Injuries

Breast Cancer, Male

Anti-Allergic Agents

Anti-Inflammatory Agents

Dermatologic Agents

All Drugs and Chemicals

Mometasone Furoate

Patients apply 2.5 mL mometasone furoate cream once daily to the treatment area (breast or chest wall) for the duration of planned radiotherapy.

Patients apply 2.5 mL of an identical-appearing placebo cream to the treatment area as in arm I.

mometasone furoate

placebo

Robert C. Miller, MD

Patricia Griffin, MD

James A. Martenson, MD

RATIONALE: Steroid therapy, such as mometasone furoate, may prevent radiation dermatitis caused by radiation therapy. It is not yet known whether mometasone furoate is more effective than a placebo in preventing radiation dermatitis.

PURPOSE: This randomized phase III trial is studying mometasone furoate to see how well it works compared to a placebo in preventing radiation dermatitis in patients undergoing radiation therapy to the breast or chest wall for invasive breast cancer or ductal carcinoma in situ.

OBJECTIVES:

Primary

* Compare the efficacy of mometasone furoate vs placebo, in terms of decreased maximal severity of radiation dermatitis, in patients undergoing primary or adjuvant radiotherapy to the breast or chest wall for invasive breast cancer or ductal carcinoma in situ.

Secondary

* Compare the incidence of severe (grade ≥ 3) radiation dermatitis in patients treated with these drugs.
* Compare the time to onset and duration of severe radiation dermatitis in these patients.
* Assess skin toxicity and quality of life of these patients.
* Assess the adverse event profile of mometasone furoate in these patients.
* Compare skin toxicity data, in terms of provider-completed and patient-reported assessments, of patients treated with these drugs.

OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are stratified according to radiation field (breast \[post-lumpectomy\] vs chest wall \[post-mastectomy\]), regional lymph nodes (treated vs not treated), and planned total radiation dose (including boost) (50-55 Gy vs \> 55 Gy). Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients apply mometasone furoate cream once daily to the treatment area (breast or chest wall) for the duration of planned radiotherapy.
* Arm II: Patients apply an identical-appearing placebo cream to the treatment area as in arm I.

Patients complete questionnaires and a symptom experience diary at baseline and periodically during study for quality of life, skin toxicity, and adverse event assessment.

After completion of radiotherapy, patients are followed for 2 weeks.

PROJECTED ACCRUAL: A total of 148 patients will be accrued for this study.

Mometasone Furoate in Preventing Radiation Dermatitis in Patients Undergoing Radiation Therapy to the Breast or Chest Wall for Invasive Breast Cancer or Ductal Carcinoma in Situ

Phase III Randomized Double-Blind Study of Mometasone Furoate Versus Placebo in the Prevention of Radiation Dermatitis in Breast Cancer Patients Receiving Radiation Therapy

Maximum grade of radiation dermatitis as measured by the Common Terminology Criteria (CTCAE) for Adverse Events (AE), Version 3.0. Grade 1 (Mild AE), Grade 2 (Moderate AE), Grade 3 (Severe AE), Grade 4 (Life-threatening or disabling AE), Grade 5 (Death related to AE).

To compare incidence of severe (Grade ≥ 3) radiation dermatitis as measured by the CTCAE v3.0 for the mometasone and placebo arms.

Mean of the Maximum Patient Reported Skin Toxicity Assessment Tool (STAT) per patient on a 0 to 5 scale during radiation treatment. Lower scores indicate less toxicity.

Patient-Reported Mean of the Maximum Total a Skindex-16 Toxicity Score per patient on a 0-6 scale during radiation treatment (Lower score indicates less toxicity).

To compare time to onset and duration of severe (Grade ≥ 3) radiation dermatitis as measured by the CTCAE v3.0 for the mometasone and placebo arms. This analysis was not completed due to too little incidence of the dermatitis.

Patient completed QOL assessment was the Linear Analogue Self-Assessment (LASA). This instrument consisted of 6 questions with responses ranging from 0 (poor QOL) to 100 (best QOL).

Mean scores of Linear Analogue Sef-Assessment (LASA) Mental, physical, emotional, social, spiritual wel-being on a 0 (as bad as it can be) to 100 (as good as it can be) scale.

Maximum SED score during radiation treatment per patient on a 0 to 10 scale (lower score is better)

National Cancer Institute (NCI)

North Central Cancer Treatment Group

Mometasone

Patients apply 2.5 mL of an identical-appearing placebo cream to the treatment area as in arm B.

Placebo

Total

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

All (169) eligible patients are included in the baseline analysis. There were 5 cancels in Arm I and 2 in Arm II.

Robert C. Miller, M.D.

Patients apply 2.5 mL of an identical-appearing placebo cream to the treatment area as in arm A.

Mean Maximum Grade of Radiation Dermatitis by Treatment Arm.

Did not experience grade >=3 radiation dermatitis

Experience grade >=3 radiation dermatitis

Incidence of Severe ( Grade >=3) Radiation Dermatitis

STAT: Discomfort/Burning

STAT: Itching

STAT: Pulling

STAT: Discomfort/Tenderness

Skin Toxicity as Measured by the Skin Toxicity Assessment Tool

Skin Toxicity as Measured by a Dermatologic Quality-of-life Instrument (Skindex-16).

This analysis was not completed due to too little incidence of the dermatitis.

Duration of Severe (Grade ≥ 3) Radiation Dermatitis as Measured by the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. This Analysis Was Not Completed Due to Too Little Incidence of the Dermatitis.

Patients who completed at least 1 assessment were evaluable for this secondary end point.

Overall Quality of Life (QOL) as Measured by Linear Analogue Self-Assessment (LASA)

Mental well-being

Physical well-being

Emotional well-being

Social well-being

Spiritual well-being

QOL Domains as Measured by LASA

ARTHRALGIA: Severe

BURN: Mild

BURN: Moderate

BURN: Severe

CELLULITES INFECTN: Moderate

COUGH: Severe

DERMATOLOGY: Mild

DERMATOLOGY: Moderate

DERMATOLOGY: Severe

FATIGUE: Moderate

PAIN: Severe

PAIN-BREAST: Moderate

PAIN-CHEST: Moderate

PRURITUS: Mild

PRURITUS: Moderate

PRURITUS: Severe

SKIN ATROPHY: Mild

SKIN ATROPHY: Moderate

SKIN HYPOPIGMENT: Mild

SKIN HYPOPIGMENT: Moderate

SKIN IRRITATION: Moderate

SKIN STRIAE: Mild

SKIN STRIAE: Moderate

Adverse Events Assessed Clinically by NCI CTCAE v3.0

Redness

Dry Peeling

Wet Peeling

Weeping

Rash

Swelling

Fatigue

Decrease in color

Band, Stripes or Lines

Adverse Events Reported by the Patient in the Symptom Experience Diary (SED).

Overall Study

Substance Related Disorders

Immune System Diseases

Syndrome

Hand-Foot Syndrome

Exanthema

Drug Eruptions

Hypersensitivity

Drug Hypersensitivity

Drug-Related Side Effects and Adverse Reactions

Chemically-Induced Disorders

Antineoplastic Agents

Micronutrients

Hematinics

Vitamins

Capecitabine

Vitamin B 6

Pyridoxal

Pyridoxine

Vitamin B Complex

Folic Acid

Trace Elements

Vitamin B6

Folate

Vitamin B9

Pyridoxine (200mg) or placebo once daily orally for 21 days out of each treatment cycle

pyridoxine hydrochloride

Yoon-Sim Yap, FRACP, MBBS

RATIONALE: Pyridoxine may help prevent hand-foot syndrome caused by capecitabine in patients with cancer. It is not yet known whether pyridoxine is more effective than a placebo in preventing hand-foot syndrome in patients with cancer.

PURPOSE: This randomized phase III trial is studying pyridoxine to see how well it works compared with a placebo in preventing hand-foot syndrome caused by capecitabine in patients with cancer.

OBJECTIVES:

Primary

* Compare the incidence of capecitabine-induced palmar-plantar erythrodysesthesia (hand-foot syndrome \[HFS\]) ≥ grade 2 in patients with cancer treated with pyridoxine hydrochloride vs placebo.

Secondary

* Compare the time to onset of HFS ≥ grade 2 in patients treated with these regimens.
* Compare the quality of life changes in patients treated with these regimens.
* Identify factors predicting toxicity from capecitabine chemotherapy.

OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are stratified according to gender and treatment setting (adjuvant/neoadjuvant vs palliative setting). Patients are randomized to 1 of 2 treatment arms.

* Arm I: Beginning concurrently with planned capecitabine treatment, patients receive oral pyridoxine hydrochloride once daily on days 1-21.
* Arm II: Beginning concurrently with planned capecitabine treatment, patients receive oral placebo once daily on days 1-21.

In both arms, treatment repeats every 21 days for up to 8 courses (until discontinuation of capecitabine treatment).

Quality of life is assessed at baseline, at the beginning of courses 2, 4, 6, and 8, and at the end of the study.

Pyridoxine in Preventing Hand-Foot Syndrome Caused by Capecitabine in Patients With Cancer

Randomized Double-Blind Placebo-Controlled Trial of Pyridoxine for Prevention of Capecitabine-Induced Hand-Foot Syndrome (HFS)

National Cancer Centre, Singapore

Respiratory Tract (Lung and Bronchial) Diseases

Digestive System Diseases

Small Cell Lung Carcinoma

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Colorectal Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Small Cell Lung Cancer

Herbal and Botanical

Cetuximab

Mitogens

Panitumumab

Erlotinib Hydrochloride

Cola

Patients will be given questionnaires for the assessment of therapy complications, psychosocial assessment and care, and quality-of-life assessment.

assessment of therapy complications

psychosocial assessment and care

quality-of-life assessment

Laurence H. Baker, DO, FACOI

RATIONALE: Questionnaires that patients can use to assess skin toxicities related to treatment may help identify the intermediate-and long-term effects of cetuximab, panitumumab, or erlotinib hydrochloride.

PURPOSE: This trial studies the validation of a cancer questionnaire for skin toxicities in patients with colorectal or lung cancer receiving cetuximab, panitumumab, or erlotinib hydrochloride.

OBJECTIVES:

Primary

* To establish psychometric properties for the Functional Assessment of Cancer Therapy Epidermal Growth Factor Receptor Inhibitor (FACT-EGFRI 18) module (based on criterion validity, known group's validity, internal consistency reliability, and responsiveness to change) as a patient-reported outcome (PRO) measure of EGFRI-induced skin-related toxicity.

Secondary

* To document minimally important differences over time for the FACT-EGFRI 18 by comparing mean changes in this PRO measure to the patient's direct assessment of change using two anchor items (change in skin condition severity and impact).
* To examine the association between toxicity profiles (severity and time to onset), and treatment profiles (e.g., delays and discontinuation) and the FACT-EGFRI 18 scores.
* To assess degree of concordance between FACT-EGFRI 18 ratings and study site physician CTCAE Version 4.0 EGFRI-Induced Dermatologic Toxicity Grading Assessment ratings.
* To evaluate feasibility outcomes.

OUTLINE: This is a multicenter study.

Patients complete the S1013 Functional Assessment of Cancer Therapy Epidermal Growth Factor Receptor Inhibitor (FACT-EGFRI 18) at baseline and prior to beginning therapy and clinical assessment. Patients also complete FACT-EGFRI 18 and the Changes in Skin Symptoms on days 1\*, 8\*\*, 15, 22, 29, 36, 43, 71, 99, and 127. Patients who do not develop any grade of papulopustular rash within 42 days are removed from study.

Investigators performing the patients' clinical assessment complete the EGFRI-Induced Dermatologic Toxicity Grading Assessment on days 1, 8, 15, 22, 29, 36, 43, 71, 99, and 127, and the Treatment Form assessment on days 22, 43, 71, 99, and 127. Nurses or clinical trial administrators (CRA) also complete the S1013 Cover Sheet for Patient Complete Questionnaires accompanying the FACT-EGFRI 18 patients' questionnaires at each schedule assessment.

NOTE: \*Patients start EGFRI therapy.

NOTE: \*\*Change in Skin Symptoms questionnaire starts on Day 8.

S1013: Validation of Cancer Questionnaire for Skin Toxicities in Patients With Colorectal Cancer or Lung Cancer Receiving Cetuximab, Panitumumab, or Erlotinib Hydrochloride

S1013: A Prospective Study of Epidermal Growth Factor Receptor (HER-1/EGFR) Inhibitor-Induced Dermatologic Toxicity: Validation of the Functional Assessment of Cancer Therapy-EGFRI 18(FACT-EGFRI 18) Questionnaire for EGFRI-Induced Skin Toxicities

SWOG Cancer Research Network

Pain

Facies

Coagulants

Vitamin K

Vitamin K 3

Menadione

Menaquinone

Naphthoquinone

Phylloquinone

Patients apply menadione topical lotion BID for 28 days.

Patients apply topical placebo lotion BID for 28 days.

menadione topical lotion

questionnaire administration

management of therapy complications

Aminah Jatoi, M.D.

This clinical trial studies menadione topical lotion in treating skin discomfort and psychological distress in patients with cancer receiving panitumumab, erlotinib hydrochloride, or cetuximab. Menadione topical lotion may prevent rash or other skin discomfort and help alleviate psychological distress and pain in patients receiving treatment with panitumumab, erlotinib hydrochloride, or cetuximab

PRIMARY OBJECTIVES:

I. Explore the effectiveness of a menadione topical lotion to the face to prevent cutaneous and psychological discomfort from epidermal growth factor receptor (EGFR) inhibitors.

SECONDARY OBJECTIVES:

I. Explore the adverse event profile of a menadione topical lotion to the face to prevent rash from EGFR inhibitors.

II. Explore whether rash or adverse events worsen over a 4 week period after this 4-week intervention.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients apply menadione topical lotion twice daily (BID) for 28 days.

ARM II: Patients apply topical placebo lotion BID for 28 days.

After completion of study treatment, patients are followed up for 4 weeks.

Menadione Topical Lotion in Treating Skin Discomfort and Psychological Distress in Patients With Cancer Receiving Panitumumab, Erlotinib Hydrochloride, or Cetuximab

A Randomized, Double-Blind Placebo-Controlled Exploration of a Topical Menadione-Containing Lotion to the Face for Prevention and Palliation of Epidermal Growth Factor Receptor Inhibitor-Induced Cutaneous Discomfort and Psychological Distress

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Mometasone Furoate in Preventing Radiation Dermatitis in Patients Undergoing Radiation Therapy to the Breast or Chest Wall for Invasive Breast Cancer or Ductal Carcinoma in Situ	NCT00438659	Breast Cancer Dermatologic Co... Radiation Toxic... Skin Reactions ...	mometasone furo... placebo	18 Years -	Alliance for Clinical Trials in Oncology
Mometasone Furoate in Preventing Radiation Dermatitis in Patients Undergoing Radiation Therapy to the Breast or Chest Wall for Invasive Breast Cancer or Ductal Carcinoma in Situ	NCT00438659	Breast Cancer Dermatologic Co... Radiation Toxic... Skin Reactions ...	mometasone furo... placebo	18 Years -	Alliance for Clinical Trials in Oncology
Pyridoxine in Preventing Hand-Foot Syndrome Caused by Capecitabine in Patients With Cancer	NCT00486213	Dermatologic Co... Palmar-plantar ... Unspecified Adu...	pyridoxine hydr... Placebo	18 Years -	National Cancer Centre, Singapore
S1013: Validation of Cancer Questionnaire for Skin Toxicities in Patients With Colorectal Cancer or Lung Cancer Receiving Cetuximab, Panitumumab, or Erlotinib Hydrochloride	NCT01416688	Colorectal Canc... Dermatologic Co... Lung Cancer Therapy-related...	assessment of t... psychosocial as... quality-of-life...	18 Years - 120 Years	SWOG Cancer Research Network
Menadione Topical Lotion in Treating Skin Discomfort and Psychological Distress in Patients With Cancer Receiving Panitumumab, Erlotinib Hydrochloride, or Cetuximab	NCT01393821	Dermatologic Co... Malignant Neopl... Pain	menadione topic... placebo questionnaire a... management of t...	18 Years -	Mayo Clinic

Spots Global Cancer Trial Database for dermatologic complications