Véronique SERVENT, MD

The objective of this study is to uncover the prevalence of vulnerability among patients aged ≥ 70 coming to the medical oncology division of the Oscar Lambret Centre, according to the short screening test Vulnerable Elders Survey 13 (VES-13).

The objective is to better understand the value of routine screening of patients before the consultation, it was proposed as a secondary objective of this study to assess the correlation between the identification of the vulnerability in the screening test VES-13 and the identification made by the clinician during the consultation. The correlation between VES-13 and opinion of the clinician for three categories of patients (self - intermediate - fragile) will also be studied.

Screening for Vulnerability in the Elderly Supported at the Oscar Lambret Centre

A patient is identified vulnerable if the score is ≥ 3

A patient will be identified as vulnerable if he/she belongs to the "intermediate" or "frail" category. The Kappa coefficient of agreement will be used to correlate the VES-13 score and clinical observations.

Hôpital Gériatrique Les Bateliers, CHRU Lille

Centre Oscar Lambret

Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma, Large B-Cell, Diffuse

Lymphoma

Lymphoma, B-Cell

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

B-cell Lymphoma

Diffuse Large B-Cell Lymphoma

Lymphosarcoma

Antineoplastic Agents

Antirheumatic Agents

All Drugs and Chemicals

Rituximab

Loncastuximab tesirine

Antineoplastic Agents, Immunological

Immunologic Factors

Participants who are unfit (per sGA) will receive Lonca-R for 3 cycles. Participants who achieve a complete response (CR) will receive Lonca-R for 1 additional cycle. Participants who achieve a partial response (PR) will receive Lonca-R for 3 additional cycles.

Lonca-R will be administered as rituximab 375 mg/m\^2 on Day 1 of Cycle 1 and loncastuximab tesirine 150 µg/kg on Day 2 of Cycle 1. During Cycle 2, Lonca-R will be administered as rituximab\* 375 mg/m\^2 and loncastuximab tesirine 150 µg/kg on Day 1. For cycles 3 and beyond, Lonca-R will be administered as rituximab 375 mg/m\^2 and loncastuximab tesirine 75 µg/kg on Day 1.

\*subcutaneous rituximab 1400mg/dose may be used during Cycle 2 and beyond

Participants who are frail (per sGA) or participants with cardiac comorbidities will receive Lonca-R for 3 cycles. Participants who achieve a CR will receive Lonca-R for 1 additional cycle. Participants who achieve a PR will receive Lonca-R for 3 additional cycles for a total of up to 6 cycles. Only participants enrolled in Cohort B, who achieve stable disease (SD) and deriving clinical benefit per the treating physician, may also receive Lonca-R for an additional 3 cycles.

Lonca-R will be administered as rituximab 375 mg/m\^2 on Day 1 of Cycle 1 and loncastuximab tesirine 150 µg/kg on Day 2 of Cycle 1. During Cycle 2, Lonca-R will be administered as rituximab\* 375 mg/m\^2 and loncastuximab tesirine 150 µg/kg on Day 1. For cycles 3 and beyond, Lonca-R will be administered as rituximab 375 mg/m\^2 and loncastuximab tesirine 75 µg/kg on Day 1.

\*subcutaneous rituximab 1400mg/dose may be used during Cycle 2 and beyond

Loncastuximab Tesirine

Cycle 1 - Intravenous (IV) Infusion. Cycle 2+ - Intravenous (IV) Infusion or Subcutaneous (SC) Administration.

The main objective of the trial is to assess the efficacy and tolerability of Lonca-R in unfit and frail participants with previously untreated DLBCL.

The primary objectives of this trial are shown below:

Cohort A: To assess the efficacy of a response-adapted treatment of Lonca-R in unfit participants with previously untreated DLBCL, high-grade B cell lymphoma (HGBCL), or Grade 3b follicular lymphoma (FL).

Cohort B: To assess the tolerability and efficacy of a response-adapted treatment of Lonca-R in frail participants with previously untreated DLBCL, or HGBCL, or Grade 3b FL who are ineligible for standard R-mini-CHOP.

The simplified geriatric assessment (sGA) developed by the Fondazione Italiana Linfomi (FIL) identifies three distinct categories (fit, unfit, and frail) based on age, activities of daily living (ADL), instrumental activities of daily living (IADL) and the Cumulative Illness Rating Scale for Geriatrics (CIRS-G). Participants will be assigned to Cohort A (unfit) or B (frail) using the sGA.

A Study of Loncastuximab Tesirine and Rituximab (Lonca-R) in Previously Untreated Unfit/Frail Participants With Diffuse Large B-cell Lymphoma (DLBCL)

A Phase 2 Open-label Study of Loncastuximab Tesirine in Combination With Rituximab (Lonca-R) in Previously Untreated Unfit/Frail Patients With Diffuse Large B-cell Lymphoma (DLBCL) (LOTIS-9)

Includes frequency and severity of adverse events (AEs) and serious AEs (SAEs) that occur after study treatment administration. Clinically significant changes from baseline in safety laboratory variables, vital signs and physical examinations will also be recorded as TEAEs/SAEs.

ECOG performance status will be assessed on a 6-point scale ranging from 0 (fully active) to 5 (dead).

Includes changes in symptoms, functions and overall health status as measured by the Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym). The FACT-Lym is scored from 0-168 where a higher score indicates a worse outcome.

ADC Therapeutics S.A.

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Heart and Blood Diseases

Nutritional and Metabolic Diseases

Gland and Hormone Related Diseases

Nervous System Diseases

Musculoskeletal Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Symptoms and General Pathology

Kidney Diseases

Hypertension

Diabetes Mellitus

Stroke

Arthritis

Lung Diseases

Frailty

Heart Failure

Chronic Disease

Osteoporosis

Bone Diseases

Bone Diseases, Metabolic

Heart Diseases

Urologic Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Metabolic Diseases

Respiratory Tract Diseases

Disease Attributes

Chronic Graft Versus Host Disease

At regular intervals (the "steps") one cluster (i.e., one site) is randomised to cross from the control to the intervention under evaluation. This process continues until all clusters have crossed over to be exposed to the intervention. At the end of the study there will be a period when all clusters are exposed. Four sites are cluster-randomized to implement MoveSTroNg at one of four start times, each three weeks apart.

Each cluster contributes observations under both control and intervention observation periods.

Exercise:A kinesiologist-led twice-weekly program. Prior to attending the program, each attendee gets a 1:1 session with the kinesiologist to decide exercise starting levels. Group exercises start with a warm-up stepping game. Participants then perform 2 sets of 8 repetitions of each exercise, gradually progressing to an intensity of 3-8 repetitions maximum. Exercises include one each of a push, pull, squat, reach/press, lunge/step-up, lift and carry movement. After, there is a 10-minute group discussion to prompt making exercise routine at home. Nutrition:Two dietitian-led interactive group seminars to promote strategies to increase protein intake and sampling of protein-rich snacks and protein supplements. Seminar topics consider the cost to prepare high protein foods, the ability of retirement home residents to alter diet, how and why to spread protein intake through the day, how much protein is in their usual choices, and easy-to-consume protein-rich snacks.

Strength and Balance Training & Nutrition Education

During periods when a site is not involved in the MoveSTroNg program, participants will continue with their usual care routine. Usual care routines should not involve strength and balance exercises.

Usual Care

There is strong evidence that specific types of exercise can improve health and physical function in older adults. While community exercise classes exist, many older adults with chronic conditions may need guidance from credentialed exercise professionals to ensure sufficient dose and progression and to address fears or low exercise self-efficacy. Furthermore, low protein intake among older adults is common and initiating exercise when nutrition is inadequate may cause weight loss and limit gains in muscle strength. The primary goal is to determine the feasibility of implementing the MoveSTroNg program under real-world conditions, measured through referral and recruitment to the program and study retention and adherence rates.

The MoveStrong trial is a 1-year pilot closed cohort stepped wedge randomized control trial (RCT) to evaluate the feasibility of implementation of the MoveStrong program. This program includes a functional exercise and nutrition program that teaches older adults with chronic diseases how to perform functional resistance and balance exercises and promote adequate protein intake and nutrition. Four sites (1 Northern and 3 Southern Ontario sites) will be cluster-randomized to implement MoveStrong at one of four start times, each three weeks apart. The primary outcome will be to determine the feasibility of recruitment and referral from diverse settings (i.e., retirement homes, community centers, and family health teams) and establish the retention and adherence to the program. Secondary objectives will determine the following: What are the participant's and provider's experience with the MoveStrong program? What is the short-term responsiveness (i.e., ability to detect change) of frailty indicators (Fried Frailty Index components), protein intake, or quality of life? Who agrees to participate? What adaptations need to be made to MoveStrong, or study methods in each setting? What is the cost relative to the benefit? Is behaviour change maintained in the maintenance period? Our long term goal is to use the information from this project to develop, implement, and evaluate a sustainable, scalable and pragmatic model to deliver strength and balance training and promote adequate protein intake among older adults with chronic diseases.

We will use a closed cohort stepped wedge design at 4 sites (1 in Northern Ontario and 3 in Southern Ontario). In a stepped wedge, sites are cluster-randomized to implement MoveSTroNg at one of four start times, each three weeks apart.

Functional Exercise and Nutrition Education Program for Older Adults

A Model for Delivering Strength Training and Nutrition Education for Older Adults (MoveStrong): A Pilot Randomized Controlled Trial

If requested we will consider sharing data. If raw data is shared, participant data will be deidentified.

Definition: Number recruited at end of rollout. The criterion for success is to recruit 10 participants at each of 4 sites.

Definition: Number retrained at post-rollout end. The criterion for success is 90% at rollout end.

Definition: Percentage of individuals that attended exercise and nutrition sessions.

The criterion for success is 70% or higher.

Fried Frailty Index Components: We will measure the change in body weight with a calibrated scale. A change of 5% (greater or lower) in 1 year is considered worse.

Fried Frailty Index Components: walking speed via the 10-meter walk test protocol. A change of 0.05 m/s is considered as a small meaningful change, while 0.13m/s is considered a substantial change.

Fried Frailty Index Components: fatigue/exhaustion via the Center for Epidemiologic Study Depression Scale-Fatigue Questions. The score ranges from 0-60 (higher scores reflect increased symptom severity)

Fried Frailty Index Components: lower physical activity via the CHAMPS Physical Activity Questionnaire for older adults. No score, but the recommended physical activity levels are 150 minutes of moderate to vigorous activity and 2 days of strength training of major muscle groups.

Fried Frailty Index Components: weakness via the Jamar hand-held dynamometer

We will use a chair with a straight back without arm rests (seat 17" high), and a stopwatch. This will assess leg strength and endurance. Scores range depending on age and sex (e.g., male 60 to 64, \< 14 chair stands is considered below average, while a male 65 to 69, \< 12 is below average).

The Four Square Step Test is used to assess dynamic stability and the ability of the subject to step over low objects forward, sideways, and backward. For older adults \> 15 seconds indicates increased risk of falls

The EuroQol 5 dimension version 5-level (EQ-5D-5L) measures quality of life using 5 dimensions, on a 5 point scale, where a higher point is considered better.

The EuroQol 5 dimension version 5-level (EQ-5D-5L) also records the respondent's self-rated health on a 20 cm vertical, visual analogue scale with endpoints labelled 'the best health you can imagine' (100) and 'the worst health you can imagine' (0). This information can be used as a quantitative measure of health as judged by the individual respondents. A higher score indicates better quality of life

We will use the Automated Self-Administered 24-Hour (ASA24®) Dietary Assessment Tool to conduct interviewer administered diet recalls for 2 weekdays and 1 weekend day. Nutrient analysis is automated and will be used to quantify and compare protein and energy intakes at baseline and follow-up only. There is no scale to this section

We will use a semi-structured interview guide to conduct exit interviews with each participant and kinesiologist. Interviews and training sessions will be audio-recorded and transcribed verbatim. Two researchers will perform thematic analyses to describe participant and provider experience and satisfaction, adaptations, and learning needs. There is no scale to this section

We will ask participants to report adverse events and falls, using Health Canada definitions. We will report serious and non-serious adverse events (total and attributable to intervention). There is no scale to this section

We will use the Productivity and Activity Index questionnaire to assess indirect resource use over the last 6 weeks of the program.There is no scale to this section

We will use the Health Utility Form to assess direct medical resource use over the last 6 weeks of the program. Direct medical costs will be measured using a closed and open-ended survey about their personnel, hospitalization, medications, rehabilitation, and test costs. This questionnaire also evaluates out of pocket expenses and transportation.There is no scale to this section

Canadian Institutes of Health Research (CIHR)

City of Lakes family Health Team

Schlegel Villages and Research Institute for Aging

YMCA

Kinnect to Wellness

University of Waterloo

Ear, Nose, and Throat Diseases

Digestive System Diseases

Sarcopenia

Peripheral Nervous System Diseases

Vertigo

Dizziness

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Muscular Atrophy

Atrophy

Neuromuscular Manifestations

Neurologic Manifestations

Pathological Conditions, Anatomical

Neuromuscular Diseases

Vestibular Diseases

Labyrinth Diseases

Labyrinthitis

Ear Diseases

Otorhinolaryngologic Diseases

Sensation Disorders

Patients in the intervention groups will receive neoadjuvant, adjuvant or first line palliative chemotherapy (for metastatic disease). In addition, all patients will undergo three months' targeted specialized physical group-based exercise and Comprehensive Geriatric Assessment with corresponding interventions

Patients in the usual care groups will receive standard treatment with neoadjuvant, adjuvant or first line palliative chemotherapy (for metastatic disease). If the patients have other health complaints, these will, as current standard procedure, be treated by oncologist or by referral to general practitioner

Vestibular rehabilitation, balance- and progressive resistance training for three months' three times/week and Comprehensive Geriatric Assessement including corresponding interventions

Targeted specialized physical group-based exercise and Comprehensive Geriatric Assessement

Katrine S Piper, PhD-Student

Jan Christensen, PhD

Cecilia M Lund, PhD

The goal of this clinical trial is to learn about the cause of dizziness and decline in walking ability in in older adults ≥65 years during chemotherapy treatment for colorectal cancer. Another goal is to investigate if a comprehensive geriatric assessment and three months' specialized physical group-based exercise three times/week can counteract muscle weakness, vertigo, instability, impaired walking balance, and neuropathy

Frequent adverse effects of chemotherapy in older adults are nausea and fatigue, but our research group have discovered a problem with many also suffering from sarcopenia, vertigo, dizziness, and peripheral neuropathy (CIPN) leading to balance and walking impairments causing increased risk of falls. Moreover, these symptoms are often underreported with inadequate awareness among health professionals leading to deficient focus on the need for targeted rehabilitation. A comprehensive geriatric assessment (CGA) can increase the number of frail, older patients completing chemotherapy and CGA-based interventions can decrease chemotherapy toxicity and improve health-related quality of life (HRQoL). Physical exercise has been shown to reduce muscle weakness, vertigo, dizziness, and impaired balance among older adults requiring limited resources. Therefore, this project aims to investigate the effectiveness of CGA and physical exercise to counteract muscle weakness, vertigo, instability, and impaired walking balance, during chemotherapy and to investigate the interaction between vertigo, postural stability and walking performance, and neuropathy and the prevalence of sarcopenia. The activities of specialized physical exercise planned in this intervention will, as hypothesized, result in a change in muscle strength, walking balance, self-perceived balance disabilities/dizziness, and fear of falling along with changes in peripheral nerve function and autonomic function and severity of CIPN which are the outcomes of this study. Accordingly, expectations are that this intervention will affect the HRQoL among older cancer patients with vertigo and walking impairments and reduce the number of falls and hospital admissions leading to a socioeconomic benefit.

The SaVe Project-Sarcopenia and Vertigo in Aging Patients With Colorectal Cancer

Changes in walking speed using 10 meter walk test measuring gaitspeed in meters per second

Changes in postural control (standing balance) using HUR SmartBalance platform

Changes in peripheral vestibular function using Video Head Impulse Test (vHIT)

Changes in orthostatic blood pressure measured from lying to standing and every minute for five minutes

Changes in body composition using bioimpedance (BIA)

Changes in muscle quality using ultrasound

Presence of frailty using Geriatric-8 (G8) scored on a 0-17 point scale. Higher score means better outcome

Presence of frailty using Clinical Frailty Scale (CFS) scored on a 1-9 point scale. Higher score means worse outcome

Description of activity level using activity tracker

Recording of exercise through a prescribed rehabilitation plan

Biomarkers of sarcopenia and inflammation collected through blood samples. To determine concentration of inflammatory cytokines; High-sensitivity C-reactive Protein (hsCRP), tumour necrosis factor alpha (TNF- α), interleukin 6 (IL6), interleukin 13 (IL-13), and of muscle atrophy and muscle wasting (growth differentiation factor 11 (GDF11), and growth differentiation factor 15 (GDF-15). Blood samples are analysed by standard ELISA-analyses for plasma samples.

Measurement of vision using a Snellen chart

Between-group difference in change in walking balance assessed with Dynamic Gait Index (DGI) scored on a 0-24 point total scale. Higher score means better outcome

Between-group difference in lower limb muscle strength and endurance

Changes in self-perceived balance disabilities/dizziness using the patient reported outcome measure Dizziness Handicap Inventory (DHI) scored on a 0-100 point total scale. Higher score means worse outcome

Changes in fear of falling using the patient reported outcome measure Short Falls Efficacy Scale International (Short FES-I) scored on a 0-28 point total scale. Higher score means worse outcome

Changes in health related quality of life using the patient reported outcome measure EORTC QLQ-C30. The total score is converted to a 0-100 scale. Higher score means better outcome

Changes in peripheral nerve function using biothesiometer mesured in 0-50 volts. Higher volts means worse outcome

Changes in autonomic function using Vagus device

Severity of chemotherapy induced peripheral neuropathy using the patient reported outcome measure EORTC QLQ-CIPN-20. The total score is converted to a 0-100 scale. Higher score means worse outcome

Changes in muscle strength using HUR Leg Press Rehab performance recorder measuring weight in kilograms

Changes in muscle strength using handgrip test measuring weight in kilograms

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Screening for Vulnerability in the Elderly Supported at the Oscar Lambret Centre	NCT01415258	Solid Tumor		70 Years -	Centre Oscar Lambret
A Study of Loncastuximab Tesirine and Rituximab (Lonca-R) in Previously Untreated Unfit/Frail Participants With Diffuse Large B-cell Lymphoma (DLBCL)	NCT05144009	Diffuse Large B...	Loncastuximab T... Rituximab	80 Years -	ADC Therapeutics S.A.
Functional Exercise and Nutrition Education Program for Older Adults	NCT04037436	Chronic Disease Frail Diabetes Mellit... Cancer Chronic Lung Di... Cardiovascular ... Congestive Hear... Hypertension Osteoporosis, O... Arthritis Stroke Kidney Diseases	Strength and Ba... Usual Care	60 Years -	University of Waterloo
The SaVe Project-Sarcopenia and Vertigo in Aging Patients With Colorectal Cancer	NCT05710809	Colorectal Canc... Oncologic Compl... Comprehensive G... Vestibular Reha... Geriatric Oncol... Sarcopenia Vertigo Cancer Rehabilitation Exercise Geriatric Elderly Frail Older Adults Chemotherapy Chemotherapy-in... Resistance Trai... Balance Trainin... Postural Stabil... Pragmatic Trial Personal Medici... Individualised	Targeted specia...	65 Years -	Rigshospitalet, Denmark
Screening for Vulnerability in the Elderly Supported at the Oscar Lambret Centre	NCT01415258	Solid Tumor		70 Years -	Centre Oscar Lambret
Functional Exercise and Nutrition Education Program for Older Adults	NCT04037436	Chronic Disease Frail Diabetes Mellit... Cancer Chronic Lung Di... Cardiovascular ... Congestive Hear... Hypertension Osteoporosis, O... Arthritis Stroke Kidney Diseases	Strength and Ba... Usual Care	60 Years -	University of Waterloo

Spots Global Cancer Trial Database for frail

Every month we try and update this database with for frail cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for frail

Every month we try and update this database with for frail cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for frail cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.