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Efficacy and Safety of the Prophylactic Use of Doxycycline +/- Vitamin K Cream

ABSTRACT: The aim of this Phase 2, two-arm, randomized, double blind placebo controlled study is to evaluate the efficacy of combination therapy of doxycycline and Vitamin K1 compared to doxycycline plus placebo for the prevention of acne-like skin rash in mCRC patients receiving first line cetuximab treatment.

DISEASE(S): Metastatic Colorectal Cancer,Colorectal Neoplasms

PROVIDER: 2106044 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Comparison of Two Preemptive Treatment Strategies of Panitumumab Mediated Skin Toxicity and Assessment of QoL in Patient With Ras-wt Colorectal Cancer

Project description:80 - 90 % of the patients treated with anti-EGFR antibodies (panitumumab or cetuximab) experience skin toxicity, mostly acne like skin rash. A standardized treatment of skin rash is neither established as standard arm for clinical trials nor as guideline for the treatment of skin toxicity in clinical practice. While an improvement of QoL has been demonstrated for panitumumab and cetuximab in comparison to best supportive care the data basis for patient related outcomes regarding skin toxicity deriving from randomized trials is still small. Recent surveys among German oncologist revealed that physicians are reluctant to use oral antibiotics as preemptive treatment . Only 19 out of 110 oncologists stated that they are thinking about using preemptive treatment in patients with acne-like skin rash. Thus, in the present trial two main questions will be addressed: (i) Can preemptive treatment with oral doxycycline be replaced by a sequential skin treatment strategy (i.e. local treatment with erythromycin followed by doxycycline in case of inefficacy = development of acne) without compromising treatment efficacy of skin toxicity treatment? (ii) Comparison of general and skin related QoL between both treatment arms.

| 2130638 | ecrin-mdr-crc

A Self-controlled Trial of Prophylactic Topical Application of Vitamin K1 Cream for Cetuximab-related Skin Rash -VANQUISH trial-

Project description:Interventions: Vitamin K1 cream Plcebo cream Primary outcome(s): The incidence of grade2-5 rash acneiform (CTCAE v4.0) of face whithin 4 weeks from starting cetuximab containing chemotherapy Study Design: Parallel Randomized

| 2625669 | ecrin-mdr-crc

Oral vitamin D for the attenuation of sunburn

Project description:Background: The diverse immunomodulatory effects of vitamin D are increasingly being recognized. However, the ability of oral vitamin D to modulate immune responses in vivo has not been established in humans. Methods: Twenty healthy adults were randomized to receive placebo or a single high dose of vitamin D3 (cholecalciferol) one hour after localized skin irradiation with an erythemogenic dose of ultraviolet radiation. Primary outcomes included skin redness, skin thickness, and tissue expression of inflammatory mediators (TNF-α and iNOS). Secondary outcomes included microarray analyses. Results: As compared to placebo, subjects receiving vitamin D3 (200,000 IU) demonstrated reduced expression of TNF-α (p=0.04) and iNOS (p=0.02) in skin biopsies 48 hours after ultraviolet light exposure. Demonstrated trends included reduced skin redness (p=0.17), and reduced skin thickness (p=0.09) in subjects receiving vitamin D3 (200,000 IU). Unsupervised clustering of individuals based on global gene expression revealed that subjects with enhanced skin barrier repair expression profiles had higher serum vitamin D3 levels (p=0.007), increased arginase expression (p=0.005), and a sustained reduction in skin redness (p=0.02) after treatment, as compared to subjects with enhanced inflammatory gene expression profiles. Conclusions: A single high dose of oral vitamin D is capable of attenuating a local sunburn response to ultraviolet radiation, suggesting that oral vitamin D may be clinically therapeutic for its immunomodulatory properties. These results have broad implications for the role of vitamin D in skin homeostasis, and implicate arginase activation as a novel mechanism by which vitamin D exerts anti-inflammatory effects in humans.

2018-02-16 | GSE86406 | GEO

Transcription profiling of human prostate cancer cells, normal epithelial prostatic cells and stroma cells from patients in placebo, selenium, vitamin E or selenium and vitamin E treatment groups

Project description:85 radical prostatectomy specimens (where 16 samples are in Placebo group (PL), 15 are in Selenium group (SE), 25 are in Vitamin E group (VE) and 27 are in Vitamin E & Selenium group (VS.Treatment groups: l-selenomethionine, 400 ug + placebo (vitamin E); vitamin E, 400 IU + placebo (l-selenomethionine); l-selenomethionine, 400 ug + vitamin E, 400 IU; placebos) were subjected to laser capture microdissection to isolate prostate cancer cells, normal epithelial prostatic cells, or stroma cells. RNA extraction and amplification were performed. Transcription profiling was conducted using the HG-U133A Affymetrix arrays.

2008-07-01 | E-MEXP-1327 | biostudies-arrayexpress

Pre-emptive Low-dose Doxycycline During Anti-EGFR Treatment

Project description:Up to 60% of patients with metastatic colorectal cancer can be treated with one of monoclonal antibodies targeted against epidermal growth factor receptor (EGFR). This treatment is associated with a specific spectrum of toxicity: acne-like rash from limited up to erythema, often with severe pruritus, sometimes combined with other types of skin toxicities (hair and nail changes). Previously in STEPP study investigators shown that pre-emptive treatment with oral doxycycline (200 mg daily), topical steroids and sun blockers reduces the number of more severe skin side effects of panitumumab. The study is designed to described the profile of skin toxicity of EGFR blocking drugs combined with low-dose doxycycline (100 mg daily) used in the pre-emptive manner.

| 2108692 | ecrin-mdr-crc

Study of Prophylactic Topical Dapsone 5% Gel Versus Moisturizer for Cetuximab-induced Papulopustular (Acneiform) Rash in Patients With mCRC or HNSCC Without Previous or Concurrent RT

Project description:The purpose of this study is to see if the investigators can prevent or reduce the severity of the Cetuximab-related acne rash. Two different topical agents will be applied to the skin. One topical agent is the dapsone gel and the other is a skin moisturizer. Dapsone gel is an FDA approved medication that you apply to the face. It is commonly used to treat acne. Skin moisturizers are recommended to patients who receive Cetuximab treatment. In addition to these topical agents they will be given a pill to take once a day. This pill has already been shown to help fight rashes from Cetuximab.

| 2150735 | ecrin-mdr-crc

Transcription profiling of human acne lesion vs. normal skin from acne and non acne patients

Project description:The pathogenesis of acne has been linked to multiple factors such as increased sebum production, inflammation, follicular hyperkeratinization, and the action of Propionibacterium acnes within the follicle. In an attempt to understand the specific genes involved in inflammatory acne, we performed gene expression profiling in acne patients. Skin biopsies were obtained from an inflammatory papule and from normal skin in six patients with acne. Biopsies were also taken from normal skin of six subjects without acne. Gene array expression profiling was conducted using Affymetrix HG-U133A 2.0 arrays comparing lesional to nonlesional skin in acne patients and comparing nonlesional skin from acne patients to skin from normal subjects. Within the acne patients, 211 genes are upregulated in lesional skin compared to nonlesional skin. A significant proportion of these genes are involved in pathways that regulate inflammation and extracellular matrix remodeling, and they include matrix metalloproteinases 1 and 3, IL-8, human beta-defensin 4, and granzyme B. These data indicate a prominent role of matrix metalloproteinases, inflammatory cytokines, and antimicrobial peptides in acne lesions. These studies are the first describing the comprehensive changes in gene expression in inflammatory acne lesions and are valuable in identifying potential therapeutic targets in inflammatory acne. Experiment Overall Design: total 18 chips. 6 for acne lesion samples, 6 for normal skin samples, 6 for non-acne patient normal skin samples

2008-06-14 | E-GEOD-6475 | biostudies-arrayexpress

Does Acne Rash During Adolescence Predict Skin Reaction to Cetuximab

Project description:The hypothesis of this study is that patients who suffered from acne vulgaris during adolescence are at greater risk of developing acneiform skin rash due to cetuximab.

| 2108857 | ecrin-mdr-crc

Skin Rash Study Before Chemotherapy in Colorectal & Head and Neck Cancer Patients

Project description:The purpose of this study is to determine if using preventive treatments such as Doxycycline (an anti-biotic) capsules, sunscreen with SPF 30, Hydrocortisone 1% cream and a moisturizer will help to reduce the incidence and severity of the skin rash associated with Cetuximab (Erbitux) when compared to receiving standard care for the treatment of skin rash.

| 2146434 | ecrin-mdr-crc

CHANGES IN THE HUMAN TRANSCRIPTOME UPON VITAMIN D SUPPLEMENTATION

Project description:Subjects of a randomized controlled trial (RCT) received either vitamin D3 (n = 47) in a weekly dose of 20,000 IU or placebo (n = 47) for a period of three to five years

2017-01-28 | GSE94138 | GEO

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