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| Name | Class |
|---|---|
| University of Helsinki | OTHER |
| University of Eastern Finland | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Individualised on-demand counselling | No Intervention | 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 | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nutritional counselling | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Nutritional status | Nutritional status was assessed by patient-generated subjective global assessment and anthropometry. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Survival | 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. | 5 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Antti Mäkitie, Professor | Helsinki University Central Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Otolaryngology - Head & Neck Surgery, Helsinki University Central Hospital and University of Helsinki | Helsinki | HUS | 00029 | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17324657 | Background | Isenring EA, Bauer JD, Capra S. Nutrition support using the American Dietetic Association medical nutrition therapy protocol for radiation oncology patients improves dietary intake compared with standard practice. J Am Diet Assoc. 2007 Mar;107(3):404-12. doi: 10.1016/j.jada.2006.12.007. | |
| 8850213 | Background |
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| Ottery FD. Definition of standardized nutritional assessment and interventional pathways in oncology. Nutrition. 1996 Jan;12(1 Suppl):S15-9. doi: 10.1016/0899-9007(96)90011-8. |
| 22709779 | Background | White JV, Guenter P, Jensen G, Malone A, Schofield M; Academy of Nutrition and Dietetics Malnutrition Work Group; A.S.P.E.N. Malnutrition Task Force; A.S.P.E.N. Board of Directors. Consensus statement of the Academy of Nutrition and Dietetics/American Society for Parenteral and Enteral Nutrition: characteristics recommended for the identification and documentation of adult malnutrition (undernutrition). J Acad Nutr Diet. 2012 May;112(5):730-8. doi: 10.1016/j.jand.2012.03.012. Epub 2012 Apr 25. |
| 42069057 | Derived | Orell H, Pohju A, Ravasco P, Schwab U, Osterlund P, Makitie AA. Get a grip! - Baseline handgrip strength and sarcopenia as predictors of survival in patients with head and neck squamous cell carcinoma. Clin Nutr ESPEN. 2026 Jun;73:103312. doi: 10.1016/j.clnesp.2026.103312. Epub 2026 Apr 30. |
| 30937304 | Derived | Orell H, Schwab U, Saarilahti K, Osterlund P, Ravasco P, Makitie A. Nutritional Counseling for Head and Neck Cancer Patients Undergoing (Chemo) Radiotherapy-A Prospective Randomized Trial. Front Nutr. 2019 Mar 18;6:22. doi: 10.3389/fnut.2019.00022. eCollection 2019. |