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NCT Number: NCT02776124

Effect of Oral Supplements on the Nutritional Status of Locally Advanced Nasopharyngeal Carcinoma Patients

Malnutrition is very common in locally advanced nasopharyngeal carcinoma(NPC) patients undergoing current chemoradiotherapy (CRT) due to dysphagia, mucositis, nausea and other treatment-related problems. Malnutrition is associated with lower physical functioning, lower immune status, more severe (grade III/IV) late RT-induced toxicities, treatment interruption of chemo(radio)therapy, lower chemotherapy response rates, hospital readmission, impaired quality of life (QoL), and increased mortality. Although the international guidelines recommend early nutritional support in the presence of nutritional risk, the best type of nutritional intervention is still unclear. Individualized dietary counseling showed beneficial effects in nutritional intake, nutritional status and QoL in head and neck cancer patients undergoing RT or CRT-treatment; oral nutritional supplements (ONS) was most acceptable in Chinese NPC patients. 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 for Chinese NPC patients.

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Key information

Conditions

Nasopharyngeal Carcinoma Carcinoma Head and Neck Neoplasms Nasopharyngeal Diseases Nasopharyngeal Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Pharyngeal Diseases Pharyngeal Neoplasms Stomatognathic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Shanghai ninth people's hospital

Shanghai, Shanghai Municipality, 200011, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Newly diagnosed、pathologically proven nasopharyngeal carcinoma（Stage III/IV）
  • Concurrent radiation and chemotherapy(platinum )
  • Karnofsky score over 60
  • No evidence of metastatic disease
  • No significant cardiac, chest, gastrointestinal or renal morbidities

Exclusion criteria

  • age <18 years
  • ongoing artificial nutrition
  • refusal

Treatment and study plan

Healing Elements,Methuselah Medical Technology

Dietary Supplement

ONS group will receive Healing Elements ONS everyday during CRT

Primary outcomes

  1. Body weight(kg)change during concurrent chemotherapy

    Time frame: every week during the course of radiotherapy, up to 6-7 weeks

Secondary outcomes

  1. Disease-free survival

    Time frame: 2 years

    From date of randomization until date of first documented disease progression or death from any cause, assessed up to 2 years.

  2. Score of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck Core 35 (EORTC QLQ-HN35) during the concurrent treatment

    Time frame: every 2 weeks during the course of radiotherapy, up to 6-7 weeks

    participants will be followed for the duration of hospital stay, an expected average of 6-7 weeks

  3. Number of participants with treatment-related adverse events as assessed by CTCAE v3.0

    Time frame: every week during the course of radiotherapy, up to 6-7 weeks

  4. Body cell mass(kg) change measured by multifrequency segmental bioelectrical impedance analysis

    Time frame: every week during the course of radiotherapy, up to 6-7 weeks

  5. Fat mass (kg) change measured by multifrequency segmental bioelectrical impedance analysis

    Time frame: every week during the course of radiotherapy, up to 6-7 weeks

  6. Fat free mass (kg) change measured by multifrequency segmental bioelectrical impedance analysis

    Time frame: every week during the course of radiotherapy, up to 6-7 weeks

  7. Skeletal muscle mass (kg) change measured by multifrequency segmental bioelectrical impedance analysis

    Time frame: every week during the course of radiotherapy, up to 6-7 weeks

  8. Phase angle(°) change measured by multifrequency segmental bioelectrical impedance analysis

    Time frame: every week during the course of radiotherapy, up to 6-7 weeks

  9. Serum albumin（g/L) change

    Time frame: every 2 weeks during the course of radiotherapy, up to 6-7 weeks

  10. Serum prealbumin（mg/dL) change

    Time frame: every 2 weeks during the course of radiotherapy, up to 6-7 weeks

  11. Serum transferrins（mg/dL）change

    Time frame: every 2 weeks during the course of radiotherapy, up to 6-7 weeks

Sponsors and collaborators

Lead sponsor

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Other

Collaborators

  • Fudan University

Registry information

Official study title

A Randomized Phase II Trial to Assess the Effect of Oral Supplements on the Nutritional Status of Locally Advanced Nasopharyngeal Carcinoma Patients During Concurrent Chemotherapy

Important dates

Study start
2014
Primary completion
2016
Study completion
2018
First posted
May 18, 2016
Registry last updated
Mar 19, 2018

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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