Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Ebru Calik Kutukcu, PhD

Breast cancer is one of the most common cancers among women in the world and its incidence reaches up to 16%.Although survival can be increased with early diagnosis and more effective therapies, physical complications such as lymphedema, upper extremity dysfunction and chronic pain are frequently seen during and/or after breast cancer treatments. It has been determined that lymphedema associated with breast cancer treatment is a factor that mediates and/or exacerbates the adverse effects of breast cancer treatments on upper extremity functional capacity and quality of life of patients.It was determined that the 6 Minute Pegboard and Ring Test (6PRT) score showed a clear relationship with the upper extremity daily living activities (ADLs), and it was concluded that the 6 Minute Pegboard and Ring Test (6PRT) test could be used as an appropriate test in pulmonary rehabilitation programs to predict and show the improvement of daily living activities (ADLs). Therefore, in this study; The results to be obtained by evaluating the validity and reliability of the 6 Minute Pegboard and Ring Test (6PRT) test in breast cancer patients will increase the use of this test in both testing arm endurance and arm exercise capacity in breast cancer patients, and predicting the effect on daily living activities (ADLs)

Breast cancer is one of the most common cancers in the world and it can be diagnosed as high as 16 percent. According to a 2016 report published by the Ministry of Health, the incidence of breast cancer in Turkey is 46.8 per 100,000 people and 17,000 women are diagnosed with breast cancer each year. While breast cancer survival rate is 80 percent in developed countries, it varies between 40 and 60 percent in low-middle income countries. While early diagnosis and more effective therapies may improve survival time, physical complications such as lymphedema, upper extremity dysfunctions and chronic pain are frequent during and/or following breast cancer treatments. Breast cancer treatment-related lymphoma is one of the most common complications that scare and disturb patients. In the report of the International Society of Lymphology (ISL), lymphedema is defined as a disease that occurs as a result of water, plasma proteins, extravascular fluid and parenchymal cell accumulation in the interstitial area depending on the low transport capacity of the lymphatic system. In secondary lymphedema, the reduced carrying capacity is usually associated with surgical, chemotherapy and/or radiotherapy related cancer treatments. The incidence of secondary upper limb lymphedema related to breast cancer treatment was found to be 16%. In the latest clinical guide on the assessment and treatment of lymphedema after the treatment of breast cancer, the risk factors of lymphedema are examined in three groups: treatment-related, patient-related and disease-related risk factors. Risk factors associated with the treatment; axillary lymph node dissection, mastectomy, excessive removal of lymph nodes, radiotherapy and chemotherapy. Patient-related risk factors include body mass index values of 30 or above, lack of regular physical activity and exercise, and changes in weight gain after surgery. Finally, the risk factor related to the disease has been reported as the presence of metastatic lymph nodes. After the breast cancer treatment, although a good level of functional improvement is observed in most patients, it is stated that the effects of these treatments on functional capacity, daily life, work and social activities and quality of life may be significant and long-lasting. Further, it has been established that lymphedema related to breast cancer treatment is a factor that mediates and/or exacerbates the negative effects of breast cancer treatments on functional capacity and on the quality of life of patients. Furthermore, as the intensity of lymphoma increases in patients with lymphedema related to breast cancer treatment, there is also an increase in emotional state changes such as stress, anxiety and fear. Upper extremity lymphedema, developed following breast cancer treatment, usually affects glenohumeral joint by increasing the stress in the tendons of the rotator cuff muscles and disrupting the scapulohumeral rhythm. Additionally, lymphedema may cause symptoms such as a decrease in muscle strength and mobility width of upper extremity, pain and fatigue and as a result may result in reduction of activity limits and functional level of upper extremity. Another factor in reducing the capacity of the upper extremity is the development of kinesiophobia related to the affected extremity in patients. Patients are able to restrict the use of extremity to prevent exacerbation of lymphedema. The reduction in functional capacity following breast cancer treatment is frequent but as far as we know there is no validated functional test to assess upper limb exercise capacity. Given that the number of women living with breast cancer increases every year, the existence of an objective clinical test for upper limb function may be a useful evaluation method.

"6 Minute Pegboard and Ring Test (6PRT)" is a valid and reliable, practical and easy-to-use test that assesses unsupported arm endurance in patients with chronic obstructive pulmonary disease (COPD), asthmatic patients and healthy persons. For the test, patients are asked to carry as many rings as possible within 6 minutes and the number of rings carried over for 6 minutes is recorded as a score. A study in patients with mild-to-very severe chronic obstructive pulmonary disease (COPD) has shown a positive association between the 6PRT score and the activity counts assessed by an accelerometer. Furthermore, it has been established that the 6PRT score represents a clear association with the upper extremity daily living activities (ADLs) and it has been concluded that the 6PRT test can be used as an appropriate test for the prediction and development of daily living activities (ADLs) in pulmonary rehabilitation programs. As a result, in this study; Results based on assessing the validity and reliability of the 6PRT test for breast cancer patients will increase the use of the test to predict the effect on daily living activities (ADLs) in patients with breast cancer, both on arm endurance and arm exercise capacity.

Demographic information: name, age, diagnosis, medical history (months of surgery), release form of lymphoma, treatments for lymphoma, radiotherapy (number of days), chemotherapy (number of cycles), surgical type (lumpectomy, segmental mastectomy, modified radical mastectomy, radical mastectomy), body weight, height, BMI dominant and affected side, curriculum vitae (CV), family history, lifestyle traits (smoking, exercise habit) will be recorded.

Arm length, arm and underarm circumference: We analyzed that your participants perimeter and length measurements of dominant side arms shall be measured using a measuring tape. If participants have developed lymphedema, the extremities of the related party will not be evaluated. Length of the arm shall be measured from acromion- to lateral limit of radial styloid process when the arm is in anatomic position. The radius of the arm shall be measured from the mid-zone between the acromion and the olecranon, around the forearm as well as the area where the arm reaches its largest diameter while it is relaxed near the body.

Evaluation of the Hand Grip Force: The hand gripping force shall be measured with the person bent by an elbow in a sitting position with his/her back vertically upright (the person's arm is attached to the body, in a neutral position and the elbow bent by 90 degrees, the wrist is neutral). For the dominant and non-dominant side measurements shall be repeated three times. Three measurements shall be averaged for both sides and recorded in Newtons (N).

Assessment of Shoulder Joint Movement Openness: Shoulder, flexion, extension, abduction, internal and external rotation joint mobility openings shall be measured actively and/or passively and the results shall be recorded as "limited" or "no limitations."

Pain Threshold Assessment: The pain threshold evaluation is performed by an algometer ('J tech Algometer', USA), from the region located in the volar region of the forearm, 10 cm distal of the medial and lateral epicondylar middle point in both upper limbs. With the 1 cm2 head of the algometer, vertical pressure will be applied to the application area and the patient will be asked to say "Yes" when they feel pain with the pressure applied. The measurement will be repeated 3 times and the pressure pain threshold values will be recorded taking the arithmetic mean of the three trials. Algometer measurement of pain threshold is a non-invasive and reliable method used in literature.

Information related to lymphedema: Individuals' lymphoma effects ("present", "none") will be questioned and recorded. Lymphedema duration will be recorded numerically (years).

Evaluation of Lymphedema: The environmental measurement shall be performed separately at both upper extremities, with a mild pressure at the patient sitting, with the forearm supination, elbow full extension and arm at 90 degrees abduction, with a non-stretching measuring tape. Peripheral measurement will be performed at ulnar styloid level in the wrist and at five cm intervals from this level to axilla. According to the environmental measurement, women with a minimum difference of 2 cm between the affected and the unaffected side are considered positive for lymphedema. The affected and unaffected arm volumes shall be calculated using the cut comfort formula (frustum method). Considering the difference between dominant and non-dominant arm volumes, 3.3% volume correction will be applied in women that have a dominant arm effect. The severity of lymphedema will be determined according to the differences between the affected and unaffected arms on volumetric measurements (calculated using frustum method). (mildly severe lymphedema: 200-\<250 ml difference; moderate-severe lymphedema: 250-\<500 ml difference: severe lymphedema: \>500 ml difference).

Evaluation of Upper Extremity Functionality: Individual upper-limb functionality will be evaluated in the "Questionnaire Disability of Arm, Shoulder and Hand (DASH)" which is a short version of the "Questionnaire Quick Disability of Arm, Shoulder and Hand (Q-DASH-T). It comprises 38 statements in total and 3 subdivisions including function/symptom, business model and musicians model. The Committee assesses problems in daily life and social life, pain, neurological symptoms and problems in work and sleep patterns. The scoring is performed using a five-stage likert scale. Scoring of the upper limb events according to this scale; 1-there is no difficulty, 2-mild difficulty, 3-moderate difficulty, 4-excessive difficulty, 5-not being able to do it at all. The total score is calculated using the formula "\[(total score of items marked/number of items marked)-1\]x25" and ranges from 0-100. "0" is the score in which the functions are not affected at all and "100" is where the functions are maximum.The Questionnaire Quick Disability of Arm, Shoulder and Hand (Q-DASH-T) is the short version of Questionnaire Disability of Arm, Shoulder and Hand (DASH) consisting of 11 questions. The scoring system is same as the long version.

Assessment of Unsupported Arm Exercise Capacity and Arm Function/Endurance: Will be assessed in "6 minute Pegboard and Ring Test-6PRT." During the test, the patient is asked to sit in front of a perforated panel and for 6 minutes to move as many rings as possible, using both hands simultaneously, from two bottom holes to two upper holes. The test is run with the test by putting on a few rings before the test. Standardized encouragement is provided every minute during the test. The number of rings carried over for 6 minutes constitutes the final score. Before and after the test, pulse oximeter questions heart rate and oxygen saturation, dyspnea with modified Borg scale, overall fatigue and arm fatigue detection. For the validity of the test, the test will be repeated in the same conditions as one week apart in the same patient.

Maximal Arm Exercise Capacity Assessment: An exercise test with an arm ergometer and a maximal symptom with a limited exercise test will be evaluated and the reliability of the 6PRT test will be used as criterion.

Evaluation of Upper Extremity Muscle Endurance: The first and second subtests of the Functional Impairment Test Hand, and Neck/Shoulder/Arm (FIT-HaNSA) test will be used to assess the upper limb muscle endurance of the individuals and will be used as criteria for the reliability of the 6PRT test. The test will be performed bilateral. During the test, the patient will be asked to place three 1 kg bottles at 10 cm intervals first on a 25 cm shelf at waist level and on the other shelf at 25 cm height, resting on a 60 pulse metronome per minute until they feel that they cannot continue for 5 minutes. Then they will be asked to place the bottles in the same manner on a shelf located 25 cm below a shelf at eye level. Patients' total time will be recorded.

Reliability and Validity of The '6 Minute Pegboard and Ring Test' in Patients With Breast Cancer

Evaluation of the Reliability and Validity of The '6 Minute Pegboard and Ring Test' Unsupported Arm Function Exercise Test in Patients With Breast Cancer

Total number of rings installed within six

Hacettepe University

Associate Professor

Behaviors and Mental Disorders

Quality of Life

Exercise intervention will be led by qualified exercise professionals online via Zoom. It will consist of two weekly 60-minute online exercise group sessions: a 5-minute warm-up, 30-minute resistance training, and a 20-minute aerobic exercise component, finishing with a 5-minute cooldown.

The warm-up will consist of mobility and activation movements. The resistance training component will consist of 9 exercises involving large muscle groups, performed with body weight or free weights. The exercises will be completed in 2-3 sets of 10-15 repetitions. The aerobic component will consist of low-impact dance exercises that move large muscle groups to increase heart rate. The cooldown will consist of breathing exercises and light stretches.

The control group will receive weekly 30-minute supervised sessions with breathing, stretching, relaxation exercises, and meditation.

Before the beginning of the exercise program, participants will receive an education session on how to use Borg's Perceived Rate of Exertion Scale (RPE) to monitor their effort during aerobic and resistance training and tips on when they may increase the exercise intensity. During the training sessions, participants in the intervention group will be asked to choose their preferred load to execute each exercise in the resistance component, told to perform the aerobic exercises at their preferred speed, and informed that they can stop exercising whenever they need to rest. The exercise professional may suggest increasing loads in specific exercises, but these increases will not be imposed on the participants. Attendance to the sessions in the intervention and control groups will be registered. Additionally, women in this group will be encouraged to perform brisk walking at their preferred intensity and receive a pedometer to increase walking motivation.

Home-based combined exercise program with self-selected intensity

Pedro GF Ramos, Msc

Pedro B. Júdice, PhD

Eliana V. Carraça, PhD

Nuno Dias, Msc

Background. Chemotherapy drugs carry many side effects that may hinder the functional performance of women with breast cancer (BC). Chemoresistance can lead to treatment failure. A relative dose intensity of chemotherapy \<85% is associated with a worse diagnosis and lower treatment efficacy. Exercise may modulate treatment response through its effects on the tumor microenvironment and treatment tolerability. The need for a pleasant and sustainable exercise practice is important, considering the psychological and physiological stress that accompanies women with a BC diagnosis during treatment. Studies investigating the effects of exercise interventions on chemotherapy completion rates are needed.

Purpose. This study aims to investigate the effects of a self-selected intensity structured supervised home-based combined exercise intervention on the chemotherapy completion rates of women with BC. Secondly, the investigators intend to analyze the impact of this intervention on functional performance, quality of life, body composition, and physical activity levels. A 3-month follow-up will investigate if physically active behavior is sustained post-intervention.

Methods. A 2-arm randomized controlled trial will be implemented in a real-world exercise setting to compare an online structured and supervised group aerobic and strength exercise intervention with an active control group during chemotherapy treatments. The study recruitment goal is 98 women with a BC diagnosis stage I-III who are scheduled to have neoadjuvant or adjuvant chemotherapy. Outcome measures will be obtained at baseline, mid-treatment (≈3 months), post-intervention (≈6 months), and 3-month follow-up. A mediation analysis will also be conducted.

Hypothesis 1: Women in the intervention will have a better completion rate than those in the control group.

Hypothesis 2: Women in the intervention will present better functional performance, body composition, PA levels, and quality of life than the control group.

Hypothesis 3: In the post-intervention period, women in the intervention group will maintain a more physically active lifestyle than women in the control group.

Study setting The Home-Combo study will take place in the Algarve, and the sample will be recruited by medical referral from various public and private hospitals across the region.

The intervention design will consider the PA/exercise preferences, perceived barriers, and facilitators of women with BC. This information will be collected before the intervention through a mixed-methods qualitative study that will include a survey and focus groups. The intervention will be conducted online to ensure the participants' safety during the chemotherapy treatment phase, as they may have compromised immunity. Also, this option was made to attenuate participants' burden caused by commuting requirements. Participants will be enrolled in two cohorts.

Criteria for discontinuing or modifying allocated interventions Participants will be informed in the pre-study initial meeting that they may leave the study anytime. Participants will be asked to refrain from continuing the intervention if a worsening clinical condition prevents them from exercising and performing the assessments safely. The exercise program might be reviewed and tailored to the participants' condition across the intervention.

Strategies to improve adherence Before implementing this study, a survey and focus-group-based study will be performed to adjust the exercise program to the preferences, perceived barriers, and facilitators of women with a breast cancer diagnosis, considering the environmental and cultural context from where the intervention will be conducted. The supervising professional will monitor adherence to the supervised sessions through presence registration. This study will also consider the participants' adherence to the control group. To attempt dropout minimization, the investigators will have an active control group.

Concomitant care Physiotherapy treatments prescribed by the participant's primary physician and any exercises prescribed to be performed at home prescribed by the physiotherapist will be allowed during the intervention. Participants in the study will be asked not to engage in other exercise and PA programs or activities outside the program. Participants in the control group will not be prohibited from performing physical activities like brisk walking.

Sample size Considering this study design, sample size calculations were made for the primary outcome with a factorial variance analysis with repeated measures as reference statistical analysis, giving an initial estimation of 82 participants. Based on previous findings and considering a 20% dropout, the sample size was estimated at 98 participants with a moderate effect size (a=0.05; statistical power=0.80) according to Cohen's D calculations, using G\* Power 3.1.

Recruitment Recruitment will occur through medical referrals from primary physicians of several public and private hospitals in the Algarve region. Additionally, the project will be presented at breast cancer-themed congresses and events, and digital flyers with information about the study will be made to assist in disseminating the project and the recruitment process. A research team member will then contact patients referred by the doctors to receive detailed information about the study. Optionally, patients can call the research team directly or contact them through email if they prefer. After confirming eligibility criteria and interest in participating in the study, patients will be asked to attend an initial session where more information will be given, and the informed consent will be signed. During that session, participants will be told they are not obliged to participate in the study and may decide to leave the project. Consent for data collection or sharing will also be obtained.

Data collection methods Assessments will be conducted in standardized conditions, in a clinical setting, in a calm and comfortable environment, in small groups, and performed by a qualified exercise professional. The assessments will be conducted in the morning, starting with the body composition measurements, followed by a 15-minute pause so participants can eat (since they will be weighted while fasting), preceded by a 10-minute warm-up with general movements to mobilize big muscle groups and the physical tests, that will be performed in the following order: shoulder angular measurements, strength, mobility, and aerobic endurance. Participants will be divided into small groups to facilitate instruction and conduction of the tests. Participants will receive the accelerometers one week before the field tests and return them on the physical assessment day. After the field measurements, all questionnaires will be delivered and answered through email (Google Forms)

Plans to promote retention The conducting exercise professional will control participants' adherence to the exercise program through a presence registry collected by the research team member with access to the list of participants' numbers. After the session, the non-interventionist research team member will pass the presence list to the respective numbers of the participants for program adherence analysis. If a participant fails to attend a session, contact will be made to ensure the participant's welfare and motivate them to participate in the next session. The data analysis will not consider participants who fail to attend 50% or more sessions. Positive feedback will be given to the participants during the sessions, as positive feedback enhances feelings of competence, enjoyment, and interest in the activity 86. Additionally, participants will be encouraged to keep an activity diary where they may register all activities performed autonomously. Participants will be contacted one week before the assessment to confirm their availability and presence. Data from participants who fail to perform the assessments during the intervention period will be excluded from data analysis. After the intervention, participants will be contacted monthly to check their well-being and keep their interest and motivation in engaging in the follow-up assessment.

Data management All the data collected in this study will be kept confidential, computerized, and encrypted in a database without any elements that may allow identification of the participants. After the participants have expressed interest and written informed consent, a number corresponding to the participant ID during the study will be provided. When the participant receives her ID number, all data inserted in the databases will not be directly linked to the participant's personal identification. A dataset will be created for each assessment time point. All datasets will be maintained by the members responsible for the investigation on a secure server of CIDEFES-UL for ten years and will be used exclusively for research purposes. Datasets used for specific analyses or to develop sub-studies will contain only the necessary variables and the demographical indicators provided to the research team members upon request to the leading investigator.

Statistical methods All data will be analyzed using IBM SPSS (version 29.0). Factorial ANCOVAS with repeated measures will be used for the primary and secondary outcomes, adjusted for potential covariates (e.g., concomitant treatments, BC diagnosis, neo-adjuvant/ adjuvant chemotherapy). Independent sample T-tests will be used to compare results between groups at each time point, considering chemotherapy completers versus non-completers. A Fisher's exact test will compare the proportion of participants who needed chemotherapy adjustments from those who did not. The intention-to-treat analysis will be conducted to ensure that all participants are included in the overall assessment, considering their compliance with the study protocol. The Last Observation Carried Forward method will be used to input missing data values. A per-protocol analysis will also be conducted without participants who failed to complete at least 50% of the training sessions. Normality plots and Kolmogorov-Smirnov tests will be performed to test the normality of outcome variables. If normality is not satisfied, non-parametric tests will be applied (e.g., Krustal-Wallis). Mediators of change (i.e., mechanisms by which RDI) will be explored using structural equation modeling (AMOS 18.0) and multiple mediation analysis (PROCESS macro for SPSS). Putative candidates will include treatment (e.g., dose planned vs. given dose, planned cycles minimum/maximum, treatment interruption ratios, response to treatment, percentage of participants who needed dose adjustments, and the mean value of dose adjustment), and physiological (e.g., body composition, functional performance, handgrip strength, PA levels) variables. Mediation occurs when a causal effect of an independent variable occurs on a dependent variable, partly or entirely explained by a mediator. Indirect effects testing will be performed using Preacher and Hayes' procedures.

Data monitoring A data monitoring committee will not be required for this trial as the interventions pose minimal risk, and participants will be protected by personal insurance throughout the study.

Harms All participants will have their adverse events monitored throughout the study, whether directly related to the intervention or not (if applicable). This monitoring will be done through self-reporting at the start of each session, registered for analysis and report purposes, or by their primary care physicians. Participants will be advised to contact the clinical team if they have difficulties.

Auditing Two authors will supervise all trial procedures and cross-check the interventionist actions and study processes. Additionally, an independent person external to the project will review the protocol.

Research ethics approval This study has received ethical approval from the collaborating hospital (UAIF 069/2024). This trial will follow the World Medical Association's Declaration of Helsinki for Human Studies.

Consent or assent Healthcare professionals will approach potential participants to determine if they are interested in participating. If they express interest, they will be referred to a research team member who will contact them. Additionally, interested participants will be allowed to share the study information with other women who have been diagnosed with breast cancer. If any of these women express interest in participating, they will also be considered after obtaining medical clearance. Once the eligibility criteria for the study are confirmed and the women express their interest in participating, they will receive the Informed Consent through email. In the informational session, women will be asked to digitally fill out and sign the Informed Consent. It will be clear to the participants that they can withdraw their consent anytime. After the informational session, a PDF copy of the signed Informed Consent will be emailed to each participant. The research team will also take additional measures to collect and share the participants' data.

2-arm pragmatic and superiority randomized controlled trial with an intervention and an active control group, with a 1:1 allocation ratio.

Participants in this group will perform a home-based combined exercise program throughout their chemotherapy treatments, starting within 1-2 weeks of its start and ending within 3-4 weeks post-treatment completion.

Women randomized to the control group will receive weekly 30-minute supervised sessions with breathing, stretching, relaxation exercises, and meditation during the intervention period.

Participants will be told they are part of an exercise intervention without any mention of a control group.

Healthcare professionals responsible for the chemotherapy prescription and administration and registering all clinical information will be blinded to the participants' groups.

None of the research team members will know the number of participants, so data analysis will be performed in a blinded setting.

If, at any given moment, a participant reveals her number to a research team member, all posterior data from that participant will be disregarded.

If a participant decides to leave the study or must abandon it due to health complications, the team member with the number information will be informed, and data will be disregarded from the analysis.

Home-Combo: an Online Home-based Combined Exercise Intervention for Women With Breast Cancer

An Online Home-based Combined Exercise Intervention With Self-selected Intensity for Women With Breast Cancer: The Home-Combo Randomized Controlled Trial.

The corresponding author will make anonymized trial data available for non-commercial research purposes upon reasonable request.

This trial's findings will be disseminated through publication in leading international oncology scientific journals and presentations at national and international conferences. In addition. the results and mediation analysis will be produced and published. As this is a pragmatic trial with highly applicable outcomes for participants and decision-makers, it presents potential for future widespread implementation through relevant stakeholders.

Participants' demographic information (e.g., age, education, marital status, and economic status) will be collected through a general information questionnaire

PA history will be collected through a general information questionnaire

Clinical history data will be retrieved from their medical records after they sign the informed consent form.

The outcome will be reported as the mean RDI (mg.m-2/wk-1), which corresponds to a fraction of the planned chemotherapy dose intensity, by dividing the dose of chemotherapy per square meter (of surface area where the drug is related) in each cycle by the number of weeks in a cycle. Information regarding the planned chemotherapy treatment and the effectively received treatment (i.e., dose, type, and duration) will be acquired from medical records after signing the informed consent 53,19. Successful chemotherapy completion rate will be considered if the RDI is ≥85% of the planned treatment. Calculations to compare the actual chemotherapy dose intensity received and the initially planned dose intensity will be calculated as total milligrams of chemotherapy divided by the product of the body surface (in square meters) and total weeks of treatment. The RDI results from the actual dose intensity received are divided by the planned dose intensity.

The 6-minute walk test will assess aerobic endurance, a standardized field test performed indoors in a 30-meter corridor with two turning points. Participants will be asked to walk the maximum distance possible.

Arm curls will assess upperbody strength. Participants will be instructed to perform as many repetitions as possible for 30 seconds with a 5-pound dumbbell.

Sit-to-stand tests assess lower body strength. Participants will be instructed to stand upright and sit entirely back on a chair as many times as possible within 30 seconds, maintaining their feet steady on the ground and the arms crossed with hands on the shoulders

Handgrip strength will be measured using a dynamometer and considered to the nearest 0.1kg. While performing the handgrip test for each hand, participants will be instructed to stand upright with feet at hip width and elbows completely stretched while applying the maximum grip continuously for more than 3 seconds.

Timed up-and-go tests will assess participants' overall mobility. Participants will be instructed to rise from a chair, walk 2.44 meters, turn around, walk back to the chair, and sit down.

A goniometer will perform shoulder flexion and abduction angular measures on both sides.

Upper limb flexibility will be assessed using the back scratch test. Participants will be instructed to pass one hand over the shoulder and the other from the bottom of the back, trying to reach both hands as close as possible.

Body composition will be measured through bioelectrical impedance (Impedimed Australia). Data regarding weight, fat mass, lean mass, water percentage, bone mass, visceral fat, and phase angle will be collected from the scale. Participants will be asked to maintain their dietary patterns before the test and refrain from intense exercise the day before. The measurement will be performed under standardized conditions. The height measurement will be considered to the nearest 0.1 cm of the participants and will be performed using a balance-mounted stadiometer (SECA, Germany), with the participants standing and bare-footed. Body weight will be measured to the nearest 0.1kg with a digital scale. BMI (kg/m2) will be calculated from weight (kg) and height (m). Participants will be asked to maintain their dietary patterns before the test and refrain from intense exercise the day before.

The height measurement will be considered to the nearest 0.1 cm of the participants and will be performed using a balance-mounted stadiometer (SECA, Germany), with the participants standing barefoot.

Body weight will be measured with a digital scale to the nearest 0.1kg.

BMI (kg/m2) will be calculated from weight (kg) and height (m).

PA levels and SB will be assessed using accelerometry (GT9 link, Actigraph). Participants will be instructed to wear the device on an elastic belt on the non-dominant hip for seven days during all waking hours, removing only to sleep. The sampling units (epochs) will be settled to 1s to ease data analysis and ensure the appropriate sensitivity of the device during low-intensity activities. According to specific established thresholds, the accelerometer counts will be categorized into sedentary, light, moderate, and vigorous activity levels. Any interval of 60 or more minutes with continuous zero counts will be considered non-wear time.

The International Physical Activity Questionnaire Short-Form (IPAQ-SF) comprises nine items that measure the weekly time spent on all intensities PA (i.e., light, moderate, and vigorous) and time spent sitting on week and weekend days. Total PA scores are calculated from the collected data and discriminated by intensity.

Quality of life will be assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30).The EORT QLQ-C30 questionnaire consists of 30 items, grouped into 8 multi-item scales (i.e., functional: physical, role, emotional, cognitive, and social; symptom: fatigue, pain, and nausea), one global health status and quality of life subscale, and 6 single-item questions (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties).

The specific module EORTC QLQ-BR45 will measure breast cancer-related quality of life. The breast cancer module QLQ-BR45 comprises five functional subscales (body image, future perspective, sexual functioning, sexual enjoyment, and breast satisfaction) and seven symptoms subscales (arm symptoms, breast symptoms, endocrine therapy, skin mucositis, endocrine sexual symptoms, systemic therapy side effects, and upset hair loss), for a total of 45 items.

Universidade Lusófona de Humanidades e Tecnologias

Grupo HPA

Associação Oncológica do Algarve

Liga Portuguesa Contra o Cancro

Centro Hospitalar Universitario do Algarve

Grupo Lusófona

Head and Neck Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Cisplatin

All patients are allocated to this arm and will undergod DXA scans and physical testing in addition to usual care/treatment

The patients will undergo 5 DXA scans fro pre- to post treatment

DXA scan

The patients will undergo tests for maximal muscle strength and functional performance before and after treatment

Physical testing

Simon Lønbro, PhD

The goal of this clinical trial is to investigate the changes in body composition in head and neck cancer patients during treatment. The main questions it aims to answer are: What is the rate of lean body mass loss and how is it associated with changes in muscle strength and functional performance? Is the lean body mass loss impacted by adding chemotherapy to the radiation treatment? Participants will be asked to undergo five body composition scans during treatment and undergo tests for muscle strength and functional performance before and after treatment.

The primary aim of the present study is to investigate the rate of decline in body composition (LBM, body weight and fat mass) as well as changes in maximal muscle strength and functional performance during radiation treatment in HNSCC patients and to investigate the association between the loss of LBM and impairments in maximal muscle strength and functional performance. Secondly, the study investigates whether adding cisplatin during chemoradiation induces exacerbated LBM loss compared to radiation alone.

50 patients are expected to be included in the study. Inclusion criteria are: (1) histologically proven squamous cell carcinoma of the larynx, pharynx, or oral cavity, (2) prescribed to radical or post-operative radiotherapy of at least 60 Gy with or without concomitant chemotherapy. Exclusion criteria were palliative radiation or participation in competing research protocols.

Five times during treatment (biweekly), patients will be asked to undergo a Dual Energy X-ray Absorptiometry scan to evaluate changes in lean body mass and fat mass. Before and after treatment patients are asked to perform three test for maximal muscle strength (one repetition maximum knee extension, chest press and leg press) as well as three functional performance test (30 s arm curl, 30 s chair rise and stair climb).

Lean Body Mass in Head and Neck Cancer Patients During Cisplatin-based Chemoradiation

One repetition maximum in knee extension (unilateral), leg press (unilateral) and chest press (bilateral)

The fastest walking/running time in a stair climb test is recorded (two flights of stairs)

The maximum number of repetitions in 30 s arm curl test are recorded

The maximum number of repetitions in 30 s chair rise test are recorded

Lean body mass in kg determined by DXA scans

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Reliability and Validity of The '6 Minute Pegboard and Ring Test' in Patients With Breast Cancer	NCT05258344	Breast Cancer Functional Perf... Upper Extremity		18 Years - 80 Years	Hacettepe University
Home-Combo: an Online Home-based Combined Exercise Intervention for Women With Breast Cancer	NCT06429189	Breast Cancer Chemotherapy Ef...	Home-based comb...	18 Years -	Grupo Lusófona
Home-Combo: an Online Home-based Combined Exercise Intervention for Women With Breast Cancer	NCT06429189	Breast Cancer Chemotherapy Ef...	Home-based comb...	18 Years -	Grupo Lusófona
Lean Body Mass in Head and Neck Cancer Patients During Cisplatin-based Chemoradiation	NCT05890859	Head and Neck C... Lean Body Mass Body Compositio...	DXA scan Physical testin...	18 Years -	Department of Public Health, Denmark
Reliability and Validity of The '6 Minute Pegboard and Ring Test' in Patients With Breast Cancer	NCT05258344	Breast Cancer Functional Perf... Upper Extremity		18 Years - 80 Years	Hacettepe University
Lean Body Mass in Head and Neck Cancer Patients During Cisplatin-based Chemoradiation	NCT05890859	Head and Neck C... Lean Body Mass Body Compositio...	DXA scan Physical testin...	18 Years -	Department of Public Health, Denmark

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