Neoplasms

Blood and Lymph Conditions

All Conditions

Symptoms and General Pathology

Hematologic Neoplasms

Frailty

Hematologic Diseases

Patients in the intervention group will follow the standard treatment and follow-uo according to the clinical protocol of the institution and will participate in an intervention program with physical exercise and nutritional support during the period in which they are receiving oncological treatment or for a maximum period of 6 months.

The patients of the control group will follow the standard treatment and follow-up according to the clinical protocol of the institution.

Nutritional support will be given to all patients according with their nutritional body composition parameters (Nutritional assessment and sarcopenia evaluation). It could be diet counselling, oral supplemented nutrition, enteral nutrition o parenteral nutrition.

Nutritional support

The exercise program, designed, applied and monitored by research staff of the Physiology Unit, will have duration of 24 weeks (6 months). The program will have a mixed structure, the participants in an individual way fulfill their training and attend group sessions (8 subjects). In addition, 3 days a week should conduct sessions that will focus on the work of balance and general strength.

Physical exercise

Hematologic Drug

Maite Antonio, MD, PhD

Josep Maria Borras, MD,PhD,Prof

Maite Antonio, MD,PhD

Clinical trial to analyze the impact of nutrition and physical exercise intervention program on the completion of treatment in older patients 70 years or older with malignant hemopathology

OBJECTIVE:

This study aims to determine wether a geriatric intervention based on an individualized program of physical exercise and nutritional support improves the ability to complete oncological treatment at the doses and time initially planned in patients ≥ 70 years affected by hematological malignancies.

DESIGN:

Prospective, clinical trial, randomized, parallel and open groups.

SETTING:

Patients ≥ 70 years recently diagnosed of malignant hematological pathology in a comprehensive cancer center

INTERVENTION:

All those patients who meet the inclusion criteria and agree to participate, will sign the corresponding informed consent and will be assessed through a CGA (comprehensive geriatric assessment), that includes the performance of a physical condition test (SPPB), and randomized to the study group or control group. Patients in the study group will participate in an intervention program with nutritional support and physical exercise during the period in which they are receiving oncological treatment or for a maximum period of 6 months. The patients of the control group will pass to follow up. All patients, regardless of the branch of study to which they are assigned, will receive the oncological treatment indicated by their doctor and a standard follow-up according to the current care protocols in the center.

DETERMINATIONS:

Main variable: proportion of adherence to treatment calculated as the percentage between the dose administered and the prescribed. Adherence over 80% will be considered acceptable.

Secondary variables: geriatric, nutritional and physical-condition parameters before and after the intervention, quality of life before and after the intervention, toxicity and complications during treatment and response to treatment.

Nutritional and Physical Exercise Intervention in Older Patients With Malignant Hemopathies

Impact of a Nutritional and Physical Exercise Intervention Program on Oncological Treatment Completion in Patients ≥70 Years Old With Malignant Hemopathies:ICOSENIORHEM Randomized Clinical Trial

Percentage between the dose administered and the prescribed.

Vulnerable Elders Survey (VES-13) (numeric variable)

Geriatric Assessment in Hematology (GAH scale) (numeric variable)

Mini-Nutritional Assessment (MNA) (numeric variable)

Basic activities of daily life (ABVD) - (Barthel scale) and instrumental activities of daily life (IADL) (Lawton-Body scale), fatigue (Borg scale) (numeric variable)

Short Portable Physical Performance (SPPB) test. Numeric variable.

Walking test 4 metres, Up-and-go test (seconds)

Weight and height will be combined to report body mass index (BMI) in kg/m2

Anthropometric evaluation of waist, hip, arm, thigh and leg perimeters (cm).

Body mass measured with electrical bioimpedance

Strength measured by Isometric dynamometry of hands (hand grip) and legs (flex-extension) (KgF)

6-minute walk test to assess functional capacity.

Number of exercise sessions completed by each participant in the intervention group.

Frequency and severity of adverse effects according to CTCAE v4.

Quality of Life Assessment: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ)for old patients with cancer. (EORTC QLQ-ELD14): numeric variable.

Time to treatment failure, time to disease progression or death from any cause, and time to disease progression

Disease-free survival, overall survival, and cancer-specific survival.

Institut d'Investigació Biomèdica de Bellvitge

University of Barcelona

Instituto de Salud Carlos III

Maite Antonio, MD, Phd

Coordinator Oncohematogeriatrics Unit. Institut Català d'Oncologia

Participants will receive individually tailored, bi-weekly nutrition counseling from a dietician via telehealth and remote monitoring through a smart phone app and wearable sensor to allow participants to log food intake while sharing their data with a dietician.

Participants will log food intake while sharing their data with a dietician in real time for 12 weeks

Fitbit Data Collection

Participants will receive individually tailored, bi-weekly nutrition counseling from a dietician via telehealth

Nutrition Counseling

Participants will take a survey at baseline and weeks 4,8,12 \& 16. (FACT-G) Questionnaire includes questions about participant's physical, social, emotional and functional well being over the past 7 days. This questionnaire uses a 5 point Likert-type scale, 0=not at all, 4=very much. A higher total score indicates better quality of life.

Survey

Emma Hume

Kea Turner, PhD

Jose M Pimiento, MD

Rutika Mehta, MD, MPH

Jessica Frakes, MD

Sarah E Hoffe, MD

Jason B Fleming, MD

Jenny Permuth, PhD

Mohammed Al-Jumayli, MD

Brian Gonzalez, PhD

Nate Parker, PhD

The purpose of the study is to assess the feasibility and patient satisfaction with the Support through Remote Observation and Nutrition Guidance (STRONG) program. The program provides nutrition support for participants living with gastroesophageal cancer who are receiving chemotherapy and radiation treatment

Support Through Remote Observation and Nutrition Guidance (STRONG) Program for Gastroesophageal Cancer (GEC) Patients

The study will be deemed feasible if ≥ 50% of eligible participants are enrolled

The study will be deemed feasible if ≥ 70% of participants enrolled at baseline will be retained at 8 weeks

The study will be deemed feasible if ≥ 60% of participants submit 3/4 study assessments

The study will be deemed acceptable if ≥ 70% of participants rate the overall intervention as satisfactory using a validated 4-item scale (score range 0-20).

The study will be deemed usable if ≥ 60% of participants rate the mobile application as easy-to-use for logging dietary intake using a validated 10-item scale (score range from 0-100).

Intervention adherence will be deemed successful if ≥ 60% of participants meet with a dietician for 4/6 visits

Intervention adherence will be deemed successful if ≥ 60% of participants track food intake for 8/12 weeks

H. Lee Moffitt Cancer Center and Research Institute

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Rare Diseases

Nasopharyngeal Carcinoma

Carcinoma

Nasopharyngeal Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Head and Neck Neoplasms

Nasopharyngeal Diseases

Pharyngeal Diseases

Stomatognathic Diseases

Otorhinolaryngologic Diseases

Nutrison was added to regular diet while the patients can be fed through mouth. Nutrison will replace regular diet by NG or PEG while the patients can not eat for serious oral mucositis.

Regular diet without other nutritional intervention.

Nutrison(400-600ml/d) will be given to Arm 1 patient between regular diet. When the daily ration was cut down to 50%,100ml/h Nutrison was added. When grade Ⅲ-Ⅳ oral mucositis appeared, total Nutrison was applied to patients by NG or PEG.

Nutrison

The chemo-radiotherapy for the local advanced nasopharyngeal carcinoma patients will induce the mucosal ulcer and damage salivary glands. Consequently, it can disturb the nutrition conditions and clinical outcomes of patients. This research tries to evaluate the nutrition status at the baseline, before and after radiotherapy, during the follow-up by the body mass index, hematological indexes, immunological indexes, and nutrition questionnaires including PG-SGA and NRS 2002. Through the evaluation of two different nutritional interventions, the investigators aim to find an optimized assessment model and the best nutrition support patterns.

All nasopharyngeal patients received radical treatment including neo-adjuvant chemotherapy and concurrent chemo-radiotherapy. At the beginning, the investigators assign patient to experimental and control groups randomly. Patients in experimental group received standard nutritional support by adding NUTRISON. Control patients will give conventional nutritional guidance. The investigators collected all the nutritional indexed at first visit, before and after radiotherapy, 1, 3, 6, 9, 12 months after radiotherapy. All these data will be set into statistical software to produce an optimized model for clinical practice.

A Research About Nutrition Impact for Local Advanced Nasopharyngeal Carcinoma Patients

A Prospective, Randomized Controlled Open Research About the Impact of Nutritional Support on the Radiation Tolerance and Clinical Outcomes for Local Advanced Nasopharyngeal Carcinoma Patients

From the first treatment to the death of any causes

From the first treatment to the progress of diseases

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Nutritional and Physical Exercise Intervention in Older Patients With Malignant Hemopathies	NCT04057443	Hematologic Mal... Old Age; Debili...	Nutritional sup... Physical exerci... Hematologic Dru...	70 Years -	L'Hospitalet de Llobregat
Nutritional and Physical Exercise Intervention in Older Patients With Malignant Hemopathies	NCT04057443	Hematologic Mal... Old Age; Debili...	Nutritional sup... Physical exerci... Hematologic Dru...	70 Years -	L'Hospitalet de Llobregat
Support Through Remote Observation and Nutrition Guidance (STRONG) Program for Gastroesophageal Cancer (GEC) Patients	NCT05438940	GastroEsophagea...	Fitbit Data Col... Nutrition Couns... Survey	18 Years -	H. Lee Moffitt Cancer Center and Research Institute
Support Through Remote Observation and Nutrition Guidance (STRONG) Program for Gastroesophageal Cancer (GEC) Patients	NCT05438940	GastroEsophagea...	Fitbit Data Col... Nutrition Couns... Survey	18 Years -	H. Lee Moffitt Cancer Center and Research Institute
Support Through Remote Observation and Nutrition Guidance (STRONG) Program for Gastroesophageal Cancer (GEC) Patients	NCT05438940	GastroEsophagea...	Fitbit Data Col... Nutrition Couns... Survey	18 Years -	H. Lee Moffitt Cancer Center and Research Institute
A Research About Nutrition Impact for Local Advanced Nasopharyngeal Carcinoma Patients	NCT02948699	Malignant Neopl...	Nutrison	18 Years - 65 Years	Zhejiang Cancer Hospital
A Research About Nutrition Impact for Local Advanced Nasopharyngeal Carcinoma Patients	NCT02948699	Malignant Neopl...	Nutrison	18 Years - 65 Years	Zhejiang Cancer Hospital

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