Neoplasms

All Conditions

Head and Neck Neoplasms

a physical activity prescription to be performed autonomously

They will receive a supervised exercise programat least 2 weeks before starting the conventional chemoradiotherapy treatment and concomitant

They will receive a supervised exercise programat 12 weeks after the first radiotherapy session, once standard treatment has finished

is a 12-week exercise program supervised by specially trained instructors combining moderate to high intensity aerobic and strength exercises (three 1 hour sessions a week).

A supervised exercise program

they will receive a prescription concerning healthy lifestyles and a personalized exercise plan

exercise prescription

Objectives:

* To evaluate the effectiveness and efficiency of an innovative supervised exercise program for patients with head and neck cancer (SEHNeCa) to ameliorate loss of lean body mass, functional capacity and quality of life during one year, compared to a reference group receiving a physical activity prescription to be performed autonomously.
* To identify the optimal timing for applying the supervised exercise program: in a Prehabilitation period, at least 2 weeks before starting the conventional chemoradiotherapy treatment and concomitant with it, or during a Rehabilitation period, starting 12 weeks after the first radiotherapy session, once standard treatment has finished. Design: a multicenter, randomized clinical trial, where patients will be randomized to 3 groups: one control group and 2 experimental with different timing of exercise intervention. Population: 120 patients diagnosed with histological locally advanced stage III-IVa-b with squamous cell carcinomas of the larynx, pharynx, oral cavity, salivary or in neck lymph nodes from an unknown primary tumour treated with curative intent undergoing radiotherapy with or without concomitant chemotherapy.

SEHNeCa program: is a 12-week exercise program supervised by specially trained instructors combining moderate to high intensity aerobic and strength exercises (three 1 hour sessions a week). Outcome measurements: main outcome variable: change in body mass index at 6 months (multy-frecuenciy imoediance). Secondary variables at basal, 7, 12, 25, and 52 weeks after the beginning of radiotherapy include quality of life (general SF-36 and cancer specific quality of life -European Organization for Research and Treatment of Cancer QLQ-C-30-),functional capacity (6 min walking test), patient reported outcomes and treatment maximum adverse events. Analyses: Differences between treatment groups in changes in outcome variables will be analyzed on an intention to treat basis. We will use linear mixed models for longitudinal analysis of repeated measurements of continuous outcomes (SAS PROC MIXED) and generalized logistic mixed models for dichotomous (SAAS PROC GLIMMIX), considering intercept and time courses as random effects and testing the significance of the interaction of time slopes by treatment group.

The SEHNeCa Supervised Exercise Project

Supervised Exercise for Head and Neck Cancer Patients Initiated Previously or After Treatment: the SEHNeCa Randomized Controlled Trial

change in body lean mass will be measured at baseline 7, 12, 25, and 52 weeks after the beginning of radiotherapy) by the multi-frequency impedance measurement technique.

evaluated with the EORTCQLQ-C-30 questionnaire associated with the head and neck 35 specific module. Cancer specific quality of life is evaluated by the European Organisation for Research and Treatment of Cancer (QLQ-C-30) questionnaire (Aaronson et al., 1993). The QLQ-C-30 questionnaire includes five functional domains (physical, role, cognitive, emotional and social; higher scores represent greater function/quality of life) and three symptom scales (fatigue, pain and nausea; lower scores represent greater quality of life/less symptom severity)

Evaluated by a manual dynamometer for higher body and by the bench press for the lower body

Evaluated by the Medical Outcomes Study 36- Item Short-Form Health Survey (SF-36). The HRQL questionnaire is measured blindly with self-administered questionnaires: the Spanish version of the SF-36 and. Questionnaire will be filled out before and after the intervention. SF-36 generates an 8-dimension health profile and two summary scores for the physical and mental components. This questionnaire has been validated in the Spanish population.

Evaluated by the shoulder pain disability index. patients place a mark on a 10cm visual analogue scale for each question. Verbal anchors for the pain dimension are 'no pain at all' and 'worst pain imaginable', and those for the functional activities are 'no difficulty' and 'so difficult it required help'. The scores from both dimensions are averaged to derive a total score. As more score, more pain the patients feels.

Evaluated by Fatigue-related measure with the FACIT-F test Predictor. a 13 items scale that measures the cancer related fatigue. The FACT-G scoring guide identifies those items that must be reversed before being added to obtain subscale totals. Negatively stated items are reversed by subtracting the response from "4". After reversing proper items, all subscale items are summed to a total, which is the subscale score.The higher score the score, the better the QOL.

Basque Health Service

Principal investigator

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Central Nervous System Depressants

All Drugs and Chemicals

Other Dietary Supplements

Benzocaine

Tannic Acid

Physical Therapy consult for post op care and general physical activity recommendation 1-4 weeks prior to starting chemotherapy.

Phone calls designed to support the patient to maintain current activity level.

Physical Therapy consult for post-op care 1-4 weeks prior to starting chemotherapy.

Exercise prescription aimed at increasing physical activity by a minimum of 10 MET hours/week.

Motivational phone calls aimed at encouraging the patient to adhere to their exercise prescription.

A physical therapist will design an exercise plan for each participant on the intervention arm. The participants randomized to the intervention arm will also receive phone calls to assist with tracking the study participant's exercise and motivating the study participant to adhere to the exercise prescription.

Exercise prescription

Mary Chamberlin, MD

This study is designed to randomly assign breast cancer patients requiring and agreeing to chemotherapy into two groups. One group will be receive an exercise prescription aimed at increasing physical activity by a minimum of 10 MET (metabolic equivalent task) hours per week. The other group will not receive a exercise prescription but their activity will be recorded. The hypothesis is that participants that are most active will exhibit improved chemotherapy completion rates, improved fitness, less fatigue and lower levels of markers for inflammation in their blood.

This is a prospective, randomized, single institution feasibility trial. The efficacy of an exercise intervention during chemotherapy for sedentary breast cancer patients will be tested. The investigators goal is to recruit 120 women and men. Assuming 20% attrition rate, 96 will be randomized to two arms, comparing patients assigned to a physical activity program plus general health education materials versus patients assigned to receive standard general health education materials only. Study measures will be obtained before intervention, at 24 weeks, and at the end of the intervention, approximately week 32.

A Randomized, Controlled Trial to Determine the Effects of an Exercise Intervention on Physical Activity During Chemotherapy for Patients With Early Stage Breast Cancer

A log will be used to record patient's exercise activity and pedometer data on a weekly and monthly basis.

The RDI is calculated by (delivered dose)/(standard dose) x 100. Delivered dose = (actual total dose in mg/m2)/ (total days required to complete the treatment) Standard dose = (recommended total dose) / (total days planned to complete the treatment)

Fatigue as measured by the FACIT-F survey

Fasting insulin levels measured in blood at baseline (day -28 to day 1) and week 32

How the participant is feeling about the exercise.

Dartmouth-Hitchcock Medical Center

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Daily undulating periodization resistance training

Continuous vigorous training 2 x per week on a cycle ergometer

Standard endurance training

Continuous moderate training 1 x per week and aerobic high intensity interval training (HIIT) 1 x per week on the cycle ergometer

Polarized endurance training

Machine based hypertrophy training 2 x per week

Standard resistance training

Machine based daily undulating periodization resistance training 1 x per week

Joachim Wiskemann, Dr.

The TOP Study is a two-stage study on individually tailored endurance and resistance training prescriptions for breast and prostate cancer patients after the end of primary therapy in order to optimize training effects.

The TOP Study is a two-stage study on individually tailored endurance and resistance training prescriptions for breast and prostate cancer patients after the end of primary therapy in order to optimize training effects.

The TOP Study Part I aims at identifying the most appropriate way of individual intensity prescription. In a descriptive cross sectional study, 20 breast and 20 prostate cancer patients perform singe endurance and resistance training sessions prescribed by means of different methods of intensity prescription. The most appropriate method of intensity prescription is identified through considering predictability/homogeneity of physiological responses as well as perceived exertion and enjoyment.

The TOP Study Part II aims at investigating the most effective training method in terms of enhancing physical fitness for both endurance and strength training. The design is an exploratory four-arm 12-week randomized controlled training intervention trial in 60 breast and 60 prostate cancer patients. In two endurance arms, vigorous continuous training is compared to a polarized program consisting of moderate training and aerobic high intensity interval training (HIIT). Similarly, in two resistance training arms, standard machine based hypertrophy training is compared to training following a daily undulating periodization design.

Individually Tailored Training Prescriptions in Cancer Patients: The TOP Study

Change in maximal oxygen uptake (VO2peak) assessed in a maximal incremental exercise test (CPET) on a cycle ergometer

Change in one repetition maximum (1RM) of the knee extensors in a machine based 1RM test

Change in maximal isokinetic peak torque (MIPT) of the knee extensors assessed in a stationary dynamometer test

Change in peak power output (PPO) assessed in a maximal incremental exercise test (CPET) on a cycle ergometer

Change in blood lactate threshold assessed in a maximal incremental exercise test (CPET) on a cycle ergometer

Change in ventilatory threshold assessed in a maximal incremental exercise test (CPET) on a cycle ergometer

Change in maximum voluntary isometric contraction (MVIC) of the knee extensors assessed in a stationary dynamometer test

Change in total work (TW) of the knee extensors assessed in a stationary dynamometer test

Change in muscular fatigue index (FI%) of the knee extensors assessed in a stationary dynamometer test

Pain during and between training sessions (Brief Pain Inventory, BPI)

Minor and major adverse events during training sessions

Changes in fatigue (Multidimensional Fatigue Inventory, MFI 20)

Changes in Quality of Life (QoL) (European Research and Treatment in Cancer Quality of Life Questionnaire, EORTC QLQ-C30)

Changes in depression (Center for Epidemiologic Studies Depression Scale, CES-D)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The SEHNeCa Supervised Exercise Project	NCT04658706	Neack and Head ... Supervised Exec...	A supervised ex... exercise prescr...	18 Years -	Basque Health Service
A Randomized, Controlled Trial to Determine the Effects of an Exercise Intervention on Physical Activity During Chemotherapy for Patients With Early Stage Breast Cancer	NCT02159157	Early Stage Bre...	Exercise prescr...	18 Years - 99 Years	Dartmouth-Hitchcock Medical Center
Individually Tailored Training Prescriptions in Cancer Patients: The TOP Study	NCT02883699	Cancer	Standard endura... Polarized endur... Standard resist... Daily undulatin...	18 Years - 75 Years	University Hospital Heidelberg
A Randomized, Controlled Trial to Determine the Effects of an Exercise Intervention on Physical Activity During Chemotherapy for Patients With Early Stage Breast Cancer	NCT02159157	Early Stage Bre...	Exercise prescr...	18 Years - 99 Years	Dartmouth-Hitchcock Medical Center
The SEHNeCa Supervised Exercise Project	NCT04658706	Neack and Head ... Supervised Exec...	A supervised ex... exercise prescr...	18 Years -	Basque Health Service

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