Neoplasms

All Conditions

Carcinoma, Squamous Cell

Head and Neck Neoplasms

Neoplasms, Squamous Cell

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Individualized on-demand counselling group was assigned to receive baseline nutritional counselling, that consisted of one dietetic consultation before (chemo)radiotherapy. During (chemo)radiotherapy on-demand counselling group patients received further counselling only on demand.

Intensive nutritional counselling consisted of protocolled counselling given by a dietitian once at baseline and on the 2nd and 4th week of treatment and at the end of chemoradiotherapy.

In both study arms, daily estimated energy requirements were calculated from the basal energy requirements according to WHO multiplied by a 1.5 activity factor and protein requirement (g/day) was calculated multiplying ideal body weight (defined as BMI 22) by 1.2 to 1.5.

Nutritional counselling

Antti Mäkitie, Professor

The purpose of this study is to assess the effect of a pre-planned patient-adjusted intensive nutritional counselling given by a dietitian several times during (chemo)radiotherapy vs. individualized nutritional counselling given by a dietitian once in the beginning of (chemo)radiotherapy and thereafter on-demand in patients with head and neck squamous cell cancer.

* A sample size of 102 patients was identified to achieve 30% reduction in prevalence of malnutrition at the end of treatment (50% to 20%), with a significance value of 5% (p \< 0.05), 90% power. The second calculation was for a sample size of 88 patients for 30% reduction in prevalence of malnutrition at the end of treatment (50% to 20%) with the significance value 5% (p\<0.05), 85% power and effect size 70%. Based on these numbers, our aim is to recruit 100 patients, with the assumption that 12% patients would be lost to follow up.
* Randomization will be performed by the minimization procedure with the Minim Program® (http://www-users.york.ac.uk/\~mb55/guide/randsery.htm). The allocation will be done according to the following criteria: 1) Stage I-II vs. Stage III-IV; 2) age \<65 vs. \>=65 year; 3) Body Mass Index \<20 vs. \>=20 kg/m2 and 4) tumour location (oral cavity-oropharynx-tonsils vs. hypopharynx-larynx vs. nasopharynx).
* Adverse events of chemoradiotherapy will be classified according to the National Cancer Institute Common Terminology Criteria for Adverse Events-3.0 (CTCAE v3.0)
* Nutritional status will be assessed by patient-generated subjective global assessment, nutritional risk screening-2002, upper-arm anthropometry (MAC, triceps skinfold thickness, MAMA), Bio-impedance, hand grip strength and weight loss.
* Survival: overall survival, disease-specific survival and disease-free survival are calculated.

Intensive Nutrition Counselling in Patients With Head and Neck Cancer

An Intervention Study Comparing Intensive Nutrition Counselling With On-demand Counselling in Patients With Head and Neck Cancer Undergoing Chemoradiotherapy

Nutritional status was assessed by patient-generated subjective global assessment and anthropometry.

Overall survival (OS) is defined as the time interval between the date of the randomization (i.e. at diagnosis) and the date of the last visit or death by any cause.

University of Helsinki

University of Eastern Finland

Helsinki University Central Hospital

Dietitian

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Breast Neoplasms

Fatigue

Breast Diseases

Skin Diseases

Patients receive tailored program of physical exercises and nutritional counseling during the course of adjuvant treatments (CT followed by RT, 27 weeks).

Tailored program of PA and nutritional counseling

Cancer-related fatigue is by far the most common symptom affecting cancer patients. Combining regular dietary counseling and tailored physical activity is associated with reduced cancer-related fatigue and can improve quality of life and body weight control. We propose to conduct a randomized controlled trial which purpose is to evaluate the effect of an intervention combining physical exercise and nutritional therapeutic education on cancer-related fatigue. To gain behavioral change towards PA and nutrition habits, interventions will take place within hospitals, on the same days of adjuvant treatments.

Effect of a Tailored Program of Physical Activity and Nutritional Counseling on Fatigue Reduction in Breast Cancer Patients Receiving an Adjuvant Treatment

A Randomized Controlled Trial to Evaluate the Effect of a Tailored Program of Physical Activity and Nutritional Counseling on Fatigue Reduction in Breast Cancer Patients Receiving Adjuvant Treatment.

Subjective fatigue is measured using the Multidimensional Fatigue Inventory (MFI-20) questionnaire

Quality of life is measured by the EORTC QLC-C30 questionnaire

Anxiety/depressive symptoms is measured by the HADS questionnaire

Physical activity level is measured by the GPAQ questionnaire

Attention fatigue is measured usingt the TAP 2.2 software

Body Mass Index is calculated using bodyweight and length measurements

Body composition (fat mass/fat-free mass ratio) is assessed by dual-energy X-ray absorptiometry (DEXA)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Intensive Nutrition Counselling in Patients With Head and Neck Cancer	NCT02159508	Head and Neck S...	Nutritional cou...	18 Years - 80 Years	Helsinki University Central Hospital
Effect of a Tailored Program of Physical Activity and Nutritional Counseling on Fatigue Reduction in Breast Cancer Patients Receiving an Adjuvant Treatment	NCT01495650	Breast Cancer	Tailored progra...	18 Years - 76 Years	Institut du Cancer de Montpellier - Val d'Aurelle
Intensive Nutrition Counselling in Patients With Head and Neck Cancer	NCT02159508	Head and Neck S...	Nutritional cou...	18 Years - 80 Years	Helsinki University Central Hospital
Intensive Nutrition Counselling in Patients With Head and Neck Cancer	NCT02159508	Head and Neck S...	Nutritional cou...	18 Years - 80 Years	Helsinki University Central Hospital

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