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NCT Number: NCT02055833

Intensive Nutritional Counseling in Head-neck Cancer Patients Undergoing Radiotherapy

In head-neck cancer patients undergoing radiotherapy (RT) malnutrition is associated with impaired quality of life, reduced survival, more frequent treatment interruptions and dose reductions. The international guidelines recommend early nutritional support in the presence of nutritional risk, as it allows preventing or treating malnutrition and improving the clinical outcomes, as well as the tolerability of oncologic treatments. Previous nutritional intervention trials in head-neck cancer patients have been conducted on small samples and did not clarify the role of oral nutritional supplements (ONS). Accordingly, although current guidelines recommend as grade A the use of ONS associated with dietary counseling for head-neck cancer patients undergoing RT, the efficacy of this nutritional intervention still needs to be evaluated in adequately sized and randomized clinical trials.

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Key information

Conditions

Head-neck Cancer Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nutrition and Dietetics Service, Fondazione IRCCS Policlinico San Matteo

Pavia, 27100, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • newly diagnosed head-neck cancer
  • indication to radiotherapy
  • Eastern Cooperative Oncology Group performance status <=2
  • availability to planned measurements and to written informed consent.

Exclusion criteria

  • age <18 years
  • ongoing artificial nutrition
  • refusal

Treatment and study plan

Intensive nutritional counseling

Dietary Supplement

Intensive nutritional counseling: nutritional counseling + oral nutritional supplements

Other names: Resource Support Plus (Nestlè Health Science)

nutritional counseling

Other

Nutritional counseling

Primary outcomes

  1. Body weight

    Time frame: 6 weeks

    Change in body weight at the end of radiotherapy (after 6 weeks)

Secondary outcomes

  1. Body weight

    Time frame: 3 months

    Change in body weight at 1 month since the end of radiotherapy

  2. Body weight

    Time frame: 5 months

    Change in body weight at 3 months since the end of radiotherapy

  3. Quality of life

    Time frame: 5 months

    Trends in quality of life during the study (assessment: at the end of radiotherapy; at 1 month and at 3 months since the end of radiotherapy)

  4. Handgrip strength

    Time frame: 5 months

    Trends in handgrip strength during the study (assessment: at the end of radiotherapy; at 1 month and at 3 months since the end of radiotherapy)

  5. Phase angle

    Time frame: 5 months

    Trends in phase angle (as surrogate of body composition) during the study (assessment: at the end of radiotherapy; at 1 month and at 3 months since the end of radiotherapy)

Other outcomes

  1. Feasibility of radiotherapy

    Time frame: 6 weeks

    Described as: number of interruptions >5 days; total duration (days); dose reduction

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia

Other

Collaborators

  • Akern Srl
  • Nestle Health Science

Registry information

Official study title

Intensive Nutritional Counseling in Head-neck Cancer Patients Undergoing Radiotherapy: a Randomized, Controlled Trial

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Feb 5, 2014
Registry last updated
May 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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