Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Rare Diseases

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

Patients with melanoma, their spouses/partners, and first-degree relatives (FDRs).

Questionnaire regarding melanoma risk-reduction.

Questionnaire

Interview via telephone about topics related to melanoma risk-reduction.

Interview

Susan Peterson, PhD

Primary Objectives:

* To conduct semi-structured interviews with melanoma patients and family members to collect descriptive information on their UVR exposure, UVR exposure-reduction practices, melanoma early detection practices, knowledge, psychosocial variables related to melanoma risk-reduction (e.g., self-efficacy, norms, and expectations), and experiences surrounding the diagnosis of melanoma in the family. Melanoma patients and family members with children will be asked about the UVR exposure and UVR exposure-reduction practices of their children, and parental practices to reduce UVR exposure among children.
* To develop behavioral and attitudinal questionnaires based on data collected during semi-structured interviews, and evaluate the appropriateness of these questionnaires using cognitive interviewing techniques.
* To develop tailored messages aimed at promoting strategies to reduce UVR exposure (e.g., wearing protective clothing, minimizing midday UVR exposure, minimizing duration of UVR exposure, using shade and sunscreen, avoiding sun lamps, and avoiding intentional tanning) and improving adherence to surveillance and screening guidelines. Messages will be developed to correspond to responses to questionnaire items.
* To assess tailored messages for their relevance, appropriateness, attractiveness and appeal, credibility, and perceived behavioral impact among melanoma patients and their family members.

Participants in Part 1 of the study will be asked to be interviewed about topics related to melanoma risk-reduction, including opinions, attitudes, beliefs, and practices related to ultraviolet radiation exposure, melanoma prevention, and melanoma detection.

Participants in Part 2 of the study will be asked to complete a written questionnaire on melanoma risk-reduction and then be interviewed to obtain feedback on how the questionnaire may be refined.

Participants in Part 3 of the study will be asked to be interviewed by telephone. Participants then will receive educational material in the form of a newsletter tailored to their interview responses. Participants then will be asked to be interviewed to obtain feedback for refining the educational material. In each part of the study, the patient/family member will receive a letter describing the study and the Consent Statement for Questionnaire and Interview Studies.

Prior to the start of the interview, the Consent Statement will be read to the patient/family member. Patients/family members may or may not choose to have the interview tape-recorded. Participants may stop the interview or questionnaire at any time and may refuse to answer any questions. At any time, the patient/family member may refuse to have the interview tape-recorded. There is no treatment associated with this study.

Melanoma Risk-Reduction Among Patients and Family Members

Melanoma Risk-Reduction Practices Among Melanoma Patients and Their Family Members

M.D. Anderson Cancer Center

Immune System Diseases

Hypersensitivity

Micronutrients

All Drugs and Chemicals

Other Dietary Supplements

Nickel

Omega 3 Fatty Acid

One capsule (4g omega-3 PUFA) daily for 3 months

Omega-3 PUFA

Gelatine

Lesley E Rhodes, MBBS, MD

Skin cancer incidence continues to rise and ultraviolet radiation (UVR) in sunlight is the principal cause. Solar UVR can promote cancer development through its ability to suppress the immune system. The purpose of this study is to determine whether dietary supplementation with omega-3 polyunsaturated fatty acids can protect human skin from UVR-induced immunosuppression.

Skin cancer is one of the most common human cancers with a rising incidence and considerable negative impact on human health. Exposure to ultraviolet radiation (UVR) in sunlight is the major aetiological factor in skin cancer initiation and progression. Human case-control studies have reported an inverse relationship between dietary fish or omega-3 polyunsaturated fatty acid (PUFA) intake and occurrence of non-melanoma skin cancer. Omega-3 PUFA have the potential to reduce the risk of photocarcinogenesis primarily by their ability to reduce production of prostaglandin E2 and consequently photoimmunosuppression. To date, no studies have assessed the impact of omega-3 PUFA on skin photoimmunosuppression in humans.

OBJECTIVE: To examine the potential of dietary omega-3 PUFA to protect against UVR-induced cutaneous immunosuppression in humans.

STUDY DESIGN: A double-blind randomised controlled nutritional study in 64 healthy human volunteers with nickel sensitivity. Volunteers will receive 3 months dietary supplementation with either omega-3 PUFA (n=32) or gelatine (n=32) both provided in identical gelatine capsules.

The aim is to quantify the influence of omega-3 PUFA on:

1. UVR-induced suppression of clinical contact hypersensitivity (CHS) responses
2. UVR-induced modulation of epidermal Langerhans cell trafficking
3. UVR-induced modulation of levels of immunoregulatory mediators

An Immunonutritional Approach to the Prevention of Skin Cancer

The Effect of Omega-3 Polyunsaturated Fatty Acids on UV-induced Immunosuppression

Measurement of the erythema of nickel-induced eczema using a reflectance instrument

University of Manchester

Professor of Experimental Dermatology

Diseases and Abnormalities at or Before Birth

Nutritional and Metabolic Diseases

Symptoms and General Pathology

Xeroderma Pigmentosum

Ichthyosis

Congenital Abnormalities

Skin Abnormalities

Infant, Newborn, Diseases

Keratosis, Actinic

Keratosis

Precancerous Conditions

Skin Diseases, Genetic

Genetic Diseases, Inborn

Photosensitivity Disorders

Pigmentation Disorders

DNA Repair-Deficiency Disorders

Metabolic Diseases

This group will receive the personalised adherence intervention in 2018 in addition to routine clinical care.

This group will receive routine clinical care and act as the control group for the primary objective: To compare the mean daily dose of UVR (SEDs) reaching the face between the intervention group and control group over a 3 week period in June to July (follow-up 1). This group will receive the intervention in 2019, to allow within group change to be assessed.

The intervention is personalised to the psychosocial factors influencing poor photoprotection for each person. These factors could include beliefs that reduce motivation to protect as well as factors that prevent intentions being translated into action. The facilitator will use behaviour change techniques to target the factor most important for each person. Standardised content related to habit formation will be received. The intervention will be delivered via 7 1:1 sessions with a facilitator (psychologists or clinical nurse specialist). Sessions 1 (1.5 hours maximum) and 6 (45 minutes) will be delivered face to face in the home of the participant and the remaining sessions will be conducted via telephone calls or skype sessions.

XPAND

Robert Sarkany, FRCP MD CCST

John Weinman, PhD, FbPsS

People with Xeroderma Pigmentosum (XP) have a genetic condition which stops their skin repairing damage from Ultraviolet Radiation (UVR). This means they are much more likely to develop potentially fatal skin cancers. The only way to reduce this damage is to rigorously protect the skin, by limiting UVR exposure. This done in a number of ways including: staying indoors; wearing protective clothing, sunscreen and glasses. People with XP can find it difficult to maintain this level of protection, putting themselves at risk.

This research will test whether an intervention designed to enhance photoprotection activities is successful. It will use a randomised controlled trial design to compare the amount of UVR reaching the face, between participants receiving the intervention and those receiving standard clinical care. The amount of UVR reaching the face is important, as this is where people with XP develop most cancers. It is dependent on the overall level of exposure to UVR in the environment, and photoprotection used.

The intervention involves a tailored conversation with the participant about their photoprotection practices. It will target both the overall exposure to UVR and the photoprotection used when outdoors, and will be conducted in 7 sessions with an intervention facilitator. The content will be dependent on the specific photoprotection behaviour being targeted (e.g., poor sunscreen application) and the reasons for poor photoprotection for each person. This could be low motivation related to doubts about the need to protect and concerns about protecting. Other barriers to protection might be lack of routines. The facilitator will provide information tailored to these beliefs and use other standard behaviour change techniques to encourage the development of "better" photoprotection habits.

The investigators predict that the intervention group will have a lower mean daily dose of UVR to the face compared to the control group in two time periods in the summer months.

Xeroderma Pigmentosum (XP) is a rare autosomal recessive inherited condition caused by defective Nucleotide Excision Repair. Patients may develop skin cancers from childhood onwards, ocular damage, and neurological deterioration. The clinical management of XP relies on minimising exposure of the skin to Ultraviolet radiation (UVR), which is the only means of preventing skin cancer and eye disease. Reduction in UVR exposure is achieved by a combination of lowering overall exposure and rigorously photoprotecting when outdoors. This involves wearing protective clothing and application of factor 50 sunscreen to any exposed skin. Evidence from new research carried out by our team, indicated that photoprotection was inadequate with room for improvement. The clinical consequence of this sub-optimal photoprotection is higher incidence of skin cancers, including malignant melanoma, which require surgery and can be life threatening.

The investigators have designed a personalised adherence intervention, using a systematic approach called Intervention Mapping, to target the determinants of UVR reaching the face. The intervention will not require advanced therapeutic skills and has been designed to be delivered by a range of healthcare professionals. It will be tailored to the predictors of photoprotection, relevant for each person, and will be delivered via seven one-to-one sessions between the intervention facilitator and patient. Sessions 1 and 6 will be delivered face to face in the home and the remaining sessions will be conducted via telephone calls or skype sessions, depending on the preference of the participant. The facilitator will use a range of behaviour change techniques to target each determinant relevant to each individual, alongside generic components to promote habit and planning which will be delivered to all. Personalised text messages, sunscreen application video and activity sheets will also be used. The intervention facilitator will use the collaborative conversational style of Motivational Interviewing.

The primary objective is to test the efficacy of a personalised adherence intervention to reduce the level of UVR reaching the face by improving adherence to UVR protection advice.

Primary objective

1. To compare the mean daily dose of UVR (SEDs) reaching the face between the intervention group and control group over a 3 week period in June to July (follow-up 1) Secondary objectives

1. To compare the mean daily dose of UVR (SEDs) reaching the face between the intervention group and control group in August to September 2018 (follow-up 2)
2. To compare photoprotection practices between the intervention group and control group in June to July (follow-up 1)
3. To compare photoprotection practices between the intervention group and control group in August to September (follow-up 2)
4. To investigate with-in group changes in photoprotection practices pre and post the intervention up to 9 months follow-up
5. To compare between group differences in mean mood, habit formation, goal priority and self-efficacy for managing barriers between the intervention group and control group in June to July (follow-up 1)
6. To compare between group differences in mean mood, habit formation, goal priority and self-efficacy for managing barriers between the intervention group and control group in August to September (follow-up 2)
7. To investigate with-in group changes in quality of life, emotional wellbeing, habitual behaviour, self-efficacy, personalised psychosocial drivers, self-rated adherence pre and post the intervention up to 9 months follow-up
8. To qualitatively explore psychosocial "mechanisms of change" related to the intervention from the perspective of the participant
9. To qualitatively explore the acceptability and feasibility of the intervention from the perspective of the participant
10. To identify the health economic cost of the intervention

Design The study will test the efficacy of the intervention using a randomised controlled trial (RCT) design. It is a "delayed RCT", the intervention group will receive the intervention in year 1 (2018) and be compared to the control group. The control group will receive the intervention in 2019. It would not be possible to complete the intervention and measurement in both groups during the same season, when UVR levels are comparable. The UVR dose to the face will be measured at baseline (21 days in March -April 2018) and will then be assessed at two follow-up periods of 21 days in 2018 (June to July; August to September) and two follow-up periods in 2019 (March, June to July) (delayed intervention group only). Psychosocial constructs and photoprotection practices will be assessed at baseline, at the start of each follow-up period (self-report questionnaires) and during these follow-up periods (daily measures on the UVR protection diary). 9 months after baseline (December 2018, 2019) self-report questionnaires will be completed. A process and acceptability evaluation will be conducted using qualitative interviews. A health economic evaluation of the intervention will be assessed by completion of questionnaires to assess health-related quality of life and service use in December 2018, 2019. The study is a main trial. There is no pilot or feasibility study due to the small population from which the sample will be obtained (adults with XP in UK without cognitive impairment).

Procedure Eligible patients will be identified from the patient list, XP Service at Guy's and St Thomas' NHS Foundation Trust and sent an invitation letter. The investigators will send out the information sheet and request that the patient contact the research team if they wish to participate. This will be followed up with a phone call answer any questions they might have and see if they wish to participate. Those wishing to take part will be visited by a member of the research team to complete the consent process and deliver study materials. Participants will complete the baseline assessment which involves wearing a UVR monitor called a dosimeter, completing a UVR protection diary for a 3 week period (March-April 2018) and questionnaires. The dosimeter is then worn continuously during the day March to September 2018. Participants are then randomised to receive the intervention in 2018 or 2019. Participants receiving the intervention in 2018, will then take part in the first 6 sessions of the intervention across 12 weeks. All participants then repeat the baseline measurement protocol. The intervention group will then receive a booster intervention session and both groups will complete a second follow-up assessment period. Intervention participants will then take part in a qualitative interview. At 9-months post baseline all participants will complete self-report questionnaires. If a participant is randomised to receive the intervention in 2019, they will repeat the procedure excluding the second follow-up assessment period and will wear the dosimeter from March to July 2019.

Data management To protect the anonymity of the participants, once consent has been given, participants will be given a unique identifier. Data recorded on paper will be stored at the XP research office at King's College London., in locked cabinets in a locked room. Data entered electronically will be stored in password protected files accessible via a drive only accessible to the XP Research Team.

Progress will be monitored by the Trial Steering Committee, Independent Steering Committee and our funder NIHR.

Sample size The target sample size is 24 accounting for potential attrition of 20%. Based on the primary outcome being the between group difference in mean daily UVR dose to the face across a period of 21 days in June to July, the target sample size of 20 individuals (excluding dropouts) leads to a total of 210 daily observations for the 10 participants randomised to each arm. In previous research, the mean daily UVR dose to the face was .27 SED (SD=.14) with a within-person correlation of ICC=.31. Adjusting for the design effect due to the dependence of assessments within individuals, and accepting a liberal 10% alpha and 20% beta level due to the rare nature of the condition, this sample size would have 80% power to detect a reduction of .10 SED in mean UVR dose to the face. In terms of standardised mean difference this relates to an effect size of d=.73, which is considered to be a large effect. Given the tailored nature and expected intensity of the intervention, expecting such a difference does not seem unreasonable though it must be accepted that power would not be sufficient to detect smaller but still clinically meaningful differences. Where the target dose to the face is 0 SED, a reduction of .1 SED relates to around a 30% overall reduction in UVR dose to the face. To allow for an estimated attrition rate of 20% the target total sample size is 24.

Analysis for primary objective The treatment effect on the primary outcome of daily UVR dose to the face during over 21 days between June and July and secondary outcome of daily UVR dose to the face during over 21 days between August and September will be estimated using generalised linear mixed models. Given the skewed distribution of UVR dose to face a logarithmic transformation will be applied. A random intercept will account for the repeated assessments of UVR dose to the face within individuals across 42 days. Group will be entered as an indicator variable along with a time period indicator (i.e. early vs late summer), any stratification factors used in the randomisation (e.g. complementation type) and baseline mean daily UVR dose to face. Two baseline levels of mean daily UVR dose to face will be included in the analysis as covariates; mean daily UVR dose to face collected in previous study (21 days between June and July 2016) and pre-intervention mean daily UVR dose to face ( 21 days between March and April 2018). Given the rare nature of the condition, the investigators will accept a higher than usual false positive rate and will accept the treatment is efficacious where the p-value for the group coefficient is p\<.1 (i.e. 10% critical alpha level). The analysis will follow the intention to treat principle with individuals analysed within the groups to which they were randomised irrespective of whether they received or persisted with the intervention. Sensitivity analysis will consider treatment effects in a per-protocol analysis of those completing the intervention.

The study will test the efficacy of the intervention using a randomised controlled trial design. It is a "delayed RCT", one group will receive the intervention in year 1 and be compared to the other "control group" in year 2. The control group will receive the intervention in year 2. The UVR dose to the face will be measured at baseline (21 days in March -April 2018) and will then be assessed at two follow-up periods in 2018 (June to July; August to September); two periods in 2019 (delayed intervention group). Psychosocial constructs will be measured by self report questionnaires at baseline and at the start of each UVR measurement period, as well as daily during these episodes. 9 months after baseline self-report questionnaires will be completed. A qualitative process evaluation will be conducted after the intervention is complete. A health economic evaluation of the intervention will be assessed by completion of HRQOL and service use questionnaires in December 2018, 2019.

Group Allocation will be concealed from the statisticians conducting the analysis until the analysis relevant to the primary study objective has been completed.

Care providers: Group allocation will be concealed from the XP clinical team who are not part of the research team. This is to avoid change in the standard care of these participants during the trial (i.e., greater/less discussion of adherence to photoprotection during the routine clinical appointment). Randomisation will be broken if the intervention facilitator is concerned about the participant's emotional wellbeing at any point during delivering the intervention. In this case the clinical team will be alerted and the participant will be referred to the clinical psychologist at the XP service for assessment.

XPAND Trial: Enhancing XP Photoprotection Activities - New Directions

The XPAND Evaluation of a Personalised Adherence Intervention to Improve Photoprotection Behaviour in Adults With Xeroderma Pigmentosum (XP): Randomised Controlled Trial.

There is no plan to make participant data available to other researchers.

Semi-structured face-to-face interviews will be conducted to explore: i) the psychological mechanisms of change which explain the change in photoprotection behaviour; ii) the acceptability of the intervention from the perspective of the participant. Topics are likely to include: whether/how the intervention changed their beliefs regarding illness/treatment, confidence and motivation to photoprotect, what aspects they liked/disliked, how helpful they found the intervention, how difficult it was to make (and sustain) changes in beliefs and practices.

This is designed for this study. It has 5 items assessing overall perceptions of the programme and its components, the impact on photoprotection behaviour and whether psychosocial variables have changed as a result of the intervention. The questionnaires assesses the extent to which respondents agree with statements about the intervention (e.g., "Overall the programme was interesting/easy to understand/ helpful" 1=Strongly disagree - 5=Completely agree). A mean score of all the items will give an overall score. A higher score indicates more favourable feedback. The questionnaire will be used to inform the content of the qualitative interviews.

To personalise the intervention for each individual participant, a profiling questionnaire was developed for this study. The questionnaire has 21 items which assess drivers associated with suboptimal adherence to photoprotection. For example "How much do you think XP treatment at the clinic can help your skin or eye health?" (0-not at all, 10-very much). A higher score indicates greater strength of each driver. The pattern of responses will be assessed to ascertain which driver/s are important for each participant. This profile will be used to guide the content of the intervention for each participant.

Self-reported validated published measure of Anxiety and Depression. It will be used to screen participant for clinical levels of anxiety and depression. It consists of 7 statements about anxiety and 7 about depression. Respondents are asked to indicate their agreement with the statement on a 4 point Likert scale. Scores range between 0 and 21 for each subscale. A score of 11\< suggests presence of a mood disorder.

The mean daily dose of UVR will be calculated by combining data from: (i) A UVR recorder wrist-worn device, (dosimeter) (ii) Patients' photoprotective activities self-monitored and recorded on a diary. The dosimeter provides real-time measurements of ambient UVR. It measures UVR in units of Standard Erythemal Dose (SEDs), every 5 seconds and records the mean every 5 minutes. The diary has a grid format with the day split into 15 minute segments. Participants record time spent outside rounded to the nearest 15 minutes and their photoprotection activity (e.g. hat, hoodie worn-up) during that time. During each 15 minute interval the dose of UVR to the face (in SEDs) equals the UVR exposure recorded by the dosimeter weighted by the protection associated with photoprotection behaviours recorded for that interval on the diary. Weights will be generated based on the degree of photoprotection afforded by each activity.

This is a self reported measure of mood. It will be measured daily by completion of a single question designed for the study. The question is: How would you describe your mood today? (0= very negative - 10=very positive). Participants respond by marking a number between 0 and 10. A higher score indicates a more positive mood. Mean daily mood will be recorded across each 21 day measurement period for each participant.

This is a self reported measure of automaticity. It will be measured daily by completion of a single question designed for the study, adapted from the Self-Report Behavioural Automaticity Index (SRBAI). The question is: How much do you agree that UVR protection of your face today was something you did automatically without thinking? (0=strongly disagree - 10= strongly agree) Participants respond by marking a number between 0 and 10. A higher score indicates greater automaticity. Mean daily automaticity will be recorded across each 21 day measurement period for each participant.

This is a self reported measure of prioritisation of UVR protection activity compared to other activities. It will be measured daily by completion of a single question designed for the study. The question is: How important was UVR protection of your face today compared to other things you wanted/needed to do? (0=not at all - 10=very important)? Participants respond by marking a number between 0 and 10. A higher scores indicates giving protection a higher priority. Mean daily prioritisation will be recorded across each 21 day measurement period for each participant.

This is a self reported measure of self efficacy for successfully carrying out UVR protection activities in the presence of barriers. It will be measured daily by completion of a single question designed for the study. The question is: How confident are you that you can protect your face well tomorrow, even if other things get in the way? (0=not at all - 10=very much so). Participants respond by marking a number between 0 and 10. A higher score indicates greater self- efficacy. Mean daily prioritisation will be recorded across each 21 day measurement period for each participant.

The EQ-5D is a standardised validated published measure of health related quality of life. It measures 5 dimensions mobility, self-care, usual activities, pain/discomfort and anxiety/depression. There are 5 responses to each domain increasing in severity (no problem to extreme problems for each domain). For each domain a higher score indicates worse health related quality of life in that domain. It also records self-rated health on a visual analogue scale (0-100), with a higher score indicating better health. A single index score can be derived from the domains giving a score between 0-1 (a higher score indicates higher health related quality of life).

Validated published measure of automaticity of behaviour. It consists of 4 items, where the respondent rates the extent to which they agree with 4 statements related to automaticity and the behaviour (UVR protection) (e.g., UVR protection is something I do automatically (1=strongly disagree - 7=strongly agree). A composite score is the mean of the four items. A higher score indicates greater automaticity.

The SWEMWBS is a validated published measure of emotional wellbeing and is composed of 7 items related to a positive aspect of wellbeing (e.g., I've been feeling useful"). Respondents rate how often they have experienced each aspect over the previous 2 weeks (e.g., none of the time rarely, some of the time, often or all of the time) on a scale of 1-5. Scores are summed and then translated to a continuous metric using conversion tables (7-35). A higher score indicates higher levels of emotional wellbeing.

This was developed for the study. The questionnaire assesses self-efficacy in the context of barriers using 5 items. Three items ask the respondent to rate their level of confidence that they can carry out a type of photoprotection behaviour (shifting timing or duration of outdoor activity, photoprotect using clothing, correctly apply sunscreen) on a 0-10 scale (0=Not at all - 10=very confident). Two items ask about confidence to carry out clothing protection and sunscreen application in the presence of a variety of barriers (e.g., How confident are you that you can photoprotect even if ....you are with new people?). A mean overall self-efficacy score will be calculated.

This was developed for the study as a secondary measure of photoprotection behaviour. It has 3 questions assessing frequency of protection over the previous 7 days (e.g., When you went outside, how often did you protect your face against UVR using protective clothing? 0=never - 10=all the time) and 2 questions asking about the amount of time spent out of doors during the day (never, 30 mins or less, up to 8 hours) and during periods when UVR is at its highest (11am-3pm). Items 1 to 3 are summed to give a score between 0-27, where a higher score indicates better photoprotection. Items 4 and 5, are reported individually.

Financial impact of the intervention will be assessed by a questionnaire assessing health service use and the costs of XP to the participant. The questionnaire is an adapted version of the Client Service Receipt Inventory (CSRI). This retrospectively assesses use of primary and secondary healthcare services (including surgical interventions), social care, medication, tests/investigations, and aids and adaptations. Other impacts of XP measured will include time lost from work and education by patients and extra time spent caring by family members.

King's College London

Newcastle University

University of Cambridge

Guy's and St Thomas' NHS Foundation Trust

Inflammation

Vitamins

Herbal and Botanical

Flavonoid

Ascorbic Acid

Vitamin C

Catechin

Epicatechin

One green tea capsule (1250mg catechin) and one vitamin C tablet (100mg) daily for 3 months

Green tea + vitamin C high dose

Placebo capsule

There is little information on the effect of oral bioactive compounds on human skin clinically despite evidence of a beneficial effect from laboratory studies. The aim of this study is to examine the effect of oral bioactive compounds (green tea and vitamin C) on the health of human skin by measuring markers of skin health directly and skin nutrient uptake.

There is little information on the effect of oral catechin, a nutritionally relevant bioactive compound, on skin health in humans in vivo despite considerable evidence for protective effects in experimental studies. Vitamin C is essential for skin health and stabilises catechins in the gut lumen. Ultraviolet radiation (UVR) in sunlight is a key environmental stressor impacting on skin health. Effects include acute inflammation and longer term photodamage.

OBJECTIVE: To examine the protective effect of catechin and vitamin C on UVR-induced inflammation.

STUDY DESIGN

(1) A double-blind randomised controlled nutritional study in 50 healthy volunteers. Volunteers will receive 3 months dietary supplement with high dose bioactive (n=25),or placebo (n=25).

The aim is to quantify the influence of catechin/vitamin C on:

1. UVR-induced inflammation
2. Leukocyte infiltration
3. Inflammatory mediators
4. Markers of photoageing
5. DNA damage
6. Bioavailability will also be assessed

(2) Bioavailability of catechin and vitamin C in skin and blood. Volunteers will receive active dietary supplement. Blood and urine samples will be taken over a period of 6 hours to determine blood bioavailability. Skin biopsies will also be taken to assess skin bioavailability. Volunteers will then receive 3 months of active dietary supplement followed by repeated sampling.

The Effect of Green Tea and Vitamin C on Skin Health

The Effect of Dietary Bioactive Compounds on Skin Health in Humans in Vivo

The UV minimum erythemal dose (MED) will be determined for each study volunteer before and after nutritional supplementation to examine if the intervention can increase the MED and therefore protect against UV-induced erythema.

Bioavailability will be assessed in volunteers participating in both the first (RCT) and second (non-randomised bioavailability) parts of the study.

University of Leeds

University of Bradford

Gland and Hormone Related Diseases

Wounds and Injuries

Thyroid Diseases

Neoplasms, Radiation-Induced

Radiation Injuries

Radiologic technologists certified by the American Registry of Radiologic Technologists (ARRT) during 1923-1980 and residing in any U.S. state or territory.

Cari M Kitahara

Researchers at the National Cancer Institute and the University of Minnesota have followed a nationwide cohort of 146,022 radiologic technologists since 1982 (Boice 1992; Doody 1998; Mohan 2003; Sigurdson 2003). This is one of the largest cohorts of medical radiation workers studied to date (Yoshinaga 2003)and the only one with substantial numbers of women (73% female), extensive covariate data, both incident and death outcomes, and estimated occupational radiation doses. The overall study objectives are to: quantify radiation dose-response for cancers of the breast, thyroid, and other radiogenic sites; assess cancer risks associated with genotypic, phenotypic, or other biologically measurable factors; and determine if genetic variation modifies radiation-related cancer risks.

More than 110,000 technologists completed at least one of three comprehensive questionnaire surveys administered over the last 20 years and 18,500 are deceased. The First Survey was mailed during 1984-1989 to 132,454 known living radiologic technologists, of whom 90,305 (68%) completed the survey (Boice 1992). The Second Survey was mailed during 1993-1998 to 126,628 known living technologists, of whom 90,972 (72%) completed the questionnaire (Sigurdson2003). Both surveys included detailed questions about employment as a radiologic technologist, family history of cancer, reproductive history, height, weight, other cancer risk factors (such as alcohol and tobacco use), history of personal diagnostic and therapeutic medical radiation procedures, and information on cancer and other health outcomes. A third follow-up of this cohort was recently completed. During 2003-2005, the Third Survey was mailed or administered by telephone to 101,694 living cohort members who had completed at least one of the two previous surveys; 73,838 technologists (73%) completed the survey. This questionnaire elicited information on medical outcomes to assess radiation-related risks, detailed calendar-specific employment data to refine the occupational ionizing radiation dose estimates, and behavioral and residential histories for estimating lifetime ultraviolet (UV) radiation exposures.

The large number of women with estimates of cumulative radiation dose to specific organs (e.g. breast) (Simon 2006; see Figure 7 and Table 9) offers at are opportunity to study effects of low-dose radiation exposure on breast and thyroid cancers, the two most sensitive organ sites for radiation carcinogenesis in women.. We are not aware of any other study population in which both quantified radiation doses and biospecimens are available for individuals with protracted low-dose ionizing radiation exposures. Incorporation of assessment of the role of genetic polymorphisms and molecular variants in DNA repair and other genetic pathways that may be functionally important in radiation carcinogenesis would provide initial results on the possible role of genetic factors in the cancer-radiation relationship. Because large numbers of women are exposed to ubiquitous low-dose radiation from occupational, medical, and environmental sources, the presence of radiation-sensitive genetic variants that influence the risk of breast and other cancers would have important public health implications.

BACKGROUND:

The Radiation Epidemiology Branch and the University of Minnesota have followed a nationwide cohort of 146,022 U.S. radiologic technologists (USRT) since 1982 to assess cancer and other disease risks associated with long-term repeated low doses of ionizing radiation. The USRT Study is the largest cohort of medical radiation workers studied to date and the only one with substantial numbers of women, extensive covariate data, incident and fatal cancer and other outcomes, estimates of individual historical occupational radiation doses, personal medical radiation doses, and personal and residential solar ultraviolet radiation (UVR) doses, and biospecimens for breast and thyroid cancer cases and comparison subjects. This cohort is uniquely suited for addressing outstanding scientific questions about differences in risk related to the nature of radiation exposure, specifically whether risks are the same from a single or a few high-dose exposures (e.g. atomic bomb, radiotherapy) or from many small exposures over time that might be mitigated by DNA repair or other mechanisms. The nationwide distribution of the cohort, with wide-ranging UVR exposures, also offers a rare opportunity to evaluate risks for non-melanoma skin cancer with UVR, which will be a major focus of study during the next few years.

OBJECTIVES:

1. Assess risks of cancer and other diseases from long-term low-dose occupational and personal medical exposures.
2. Assess risks of cancer and other diseases from occupational exposure to emerging and evolving radiologic modalities (i.e. nuclear medicine, fluoroscopically-guided procedures).
3. Assess risks of skin and other cancers from solar ultraviolet radiation exposures.
4. Conduct discovery of genetic determinants for thyroid cancer and rapid replication of main genotype effects for breast cancer.
5. Evaluate gene-radiation and ionizing radiation-ultraviolet radiation interactions.

ELIGIBILITY:

All radiologic technologists certified by the American Registry of Radiologic Technologists for at least two years during 1926-1982 were eligible for study. Excluded were technologists who resided outside the U.S.

DESIGN:

Cohort study: The full USRT cohort consists of 146,022 radiologic technologists. The cohort is predominantly female (73%), Caucasian (93%), and presently 67 years old on average; 83% are living and 16% are deceased or presumed deceased. Three questionnaire surveys were conducted during 1983-2005 to collect information on occupational, personal medical, and personal and ambient residential ultraviolet radiation exposures, other cancer risk factors, and cancer and other disease outcomes. More than 110,000 technologists participated in the first and/or second surveys. The most recent follow-up (third survey) was conducted during 2003-2005 to obtain detailed work history information for improving occupational dosimetry. Enhanced estimates of individual annual badge dose (personal dose equivalent) and radiation absorbed doses to 12 organs and tissues (breast, thyroid, brain, red bone-marrow, lung, heart, ovary, colon, testes, skin of extremities, skin of head and neck, and lens of eye) were recently completed for survey participants. Linear dose-response analyses are underway to quantify risks from protracted low-dose radiation for cancers (e.g., breast, thyroid) and other radiation-related diseases (e.g., cardiovascular, cataracts). A fourth questionnaire survey is under development and will collect information on cancer and other disease outcomes, work history with nuclear medicine and fluoroscopically-guided procedures, and other risk factors. Fourth survey outcomes will be used to assess incident cancer risks with UVR exposure data collected on the third survey. Collection of blood or buccal cell samples from breast and thyroid cancer cases and comparison subjects continues. Future plans include a case-control study of basal cell carcinoma to assess risks with ultraviolet and ionizing radiation exposure, genetic variants, and interactions.

Cancer Risk in X-Ray Technologists: Second Survey

Cancer Risk in X-Ray Technologists

Occupational ionizing radiation-related risks for cancer and other medical outcomes.

Cancer and other disease risks associated with ultraviolet radiation exposure.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Melanoma Risk-Reduction Among Patients and Family Members	NCT00510302	Melanoma	Questionnaire Interview	18 Years -	M.D. Anderson Cancer Center
An Immunonutritional Approach to the Prevention of Skin Cancer	NCT01032343	Skin Cancer	Omega-3 PUFA Gelatine	18 Years -	University of Manchester
XPAND Trial: Enhancing XP Photoprotection Activities - New Directions	NCT03445052	Xeroderma Pigme...	XPAND	16 Years -	Guy's and St Thomas' NHS Foundation Trust
An Immunonutritional Approach to the Prevention of Skin Cancer	NCT01032343	Skin Cancer	Omega-3 PUFA Gelatine	18 Years -	University of Manchester
The Effect of Green Tea and Vitamin C on Skin Health	NCT01032031	Skin Cancer	Green tea + vit... Placebo capsule	18 Years - 65 Years	University of Manchester
Cancer Risk in X-Ray Technologists: Second Survey	NCT00410475	Radiation-Induc... Breast+Neoplasm... Thyroid+Neoplas...		18 Years - 110 Years	National Institutes of Health Clinical Center (CC)

Spots Global Cancer Trial Database for ultraviolet radiation