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Chemo/XRT +/- Amifostine to Assess Outcomes Related to Xerostomia, Mucositis, & Dysphagia

28. maj 2017 opdateret af: Barbara Murphy, MD, Vanderbilt-Ingram Cancer Center

Randomized Pilot Trial of Chemoradiation Plus or Minus Amifostine to Assess Potential Nutritional, Inflammatory and Physical Outcomes Related to Xerostomia, Mucositis and Dysphagia

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Amifostine may decrease the side effects caused by chemotherapy and radiation therapy. It is not yet known whether chemotherapy and radiation therapy are more effective with or without amifostine in treating head and neck cancer.

PURPOSE: This randomized phase II trial is studying amifostine to see how well it works compared with standard care in reducing side effects in patients undergoing chemotherapy and radiation therapy for stage III or stage IV head and neck cancer.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

OBJECTIVES:

Primary

  • To compare the incidence and severity of acute and chronic swallowing dysfunction in stage III or IV head and neck cancer patients receiving concurrent chemoradiation with or without amifostine

Secondary

  • To assess the relative incidence and severity of acute and chronic xerostomia in stage III or IV head and neck cancer patients receiving chemoradiation with or without amifostine.
  • To assess the relative incidence and severity of mucositis and mucositis-related inflammation in stage III or IV head and neck cancer patients receiving chemoradiation with or without amifostine.
  • To assess the effects of dysphagia, xerostomia, and mucositis-related inflammation on nutritional, physical, and functional status

OUTLINE: Patients undergo intensity-modulated radiotherapy (IMRT) and concurrent chemotherapy comprising carboplatin and paclitaxel weekly.

Patients are randomized to 1 of 2 treatment arms.

  • Arm I (standard of care): Patients are further divided into 1A or 1B.

    • Arm IA: Standard of care plus standardized nutrition therapy (SNT)
    • Arm IB: Standard of care plus standardized nutrition therapy plus low weight resistance training (LWRT).

  • Arm II (amifostine): Patients are further divided into 2A or 2B.

    • Arm IIA: Amifostine 500mg diluted in 2.9 ml injected 30-60 minutes prior to each radiation dose plus standardized nutrition therapy
    • Arm IIB: Amifostine 500mg diluted in 2.9 ml injected 30-60 minutes prior to each radiation dose plus standardized nutrition therapy plus low weight resistance training

In all arms, patients undergo swallowing function, dietary, body composition, muscle, and physical and functional performance measurements at baseline and at 1, 3, and 6 months post-therapy. Quality of life, salivary production, fatigue, and symptoms (including swallowing/eating foods, appetite, weight loss/nutrition, pain, and speech/communication) are assessed at baseline and at 1, 3, and 6 months post-therapy. Anthropometric measurements are also performed at the above time points and at mid-therapy.

Blood samples and buccal rinses are collected at baseline and at 1, 3, and 6 months post-therapy for biomarker studies and for proteomic and genomic analysis by liquid chromatography and tandem mass spectrometry.

After completion of study treatment, patients are followed at 1, 3, and 6 months.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

41

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Tennessee
      • Nashville, Tennessee, Forenede Stater, 37232-6838
        • Vanderbilt-Ingram Cancer Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

21 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria

  • Age greater than 21
  • Biopsy proven stage 3 or 4 squamous cell carcinoma of the larynx, pharynx, oral cavity or salivary glands
  • No prior history of active cancer within three years other than non-melanoma skin cancer, early stage prostate or early stage cervical cancer
  • controlled co-morbid disease
  • ECOG PS of 0-3
  • Plan for definitive or post-operative CCR within 4 weeks
  • Written informed consent
  • Working telephone
  • May have received prior induction chemotherapy
  • Agree to use only study supplied liquid nutrition supplements or dietary supplements, for per os or feeding tube intake

Exclusion Criteria

  • Diagnosed HIV or AIDS
  • History of ETOH or drug abuse within 3 months
  • Pregnant or lactating
  • On steroid medication or prescribed NSAIDs
  • Consuming specialty nutrition supplements containing additional amounts of eicosapentaenoic acid (EPA) or docosahexaenoic acid (DHA)
  • On orexigenic (appetite stimulant) medication.
  • Uncontrolled comorbid disease defined as: a) severe cardiac disease Class III or greater; b) blood pressure > 160/95; c) uncontrolled pain
  • Does not have working telephone.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Arm IA
Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction.
Procedure: therapeutic dietary intervention
Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction.
Aktiv komparator: Arm IB
Patients undergo SNT and low weight resistance training (LWRT).
Procedure: therapeutic dietary intervention
Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction.
Adfærdsmæssigt: exercise intervention
Patients undergo low weight resistance training.
Eksperimentel: Arm IIA
Patients receive amifostine subcutaneously (SC) 30-60 minutes prior to each dose of intensity-modulated radiotherapy (IMRT). Patients also undergo SNT as in arm IA.
Procedure: therapeutic dietary intervention
Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction.
Medicin: amifostine trihydrate
Given subcutaneously
Andre navne:
  • Ethyol
Eksperimentel: Arm IIB
Patients receive amifostine SC 30-60 minutes prior to each dose of IMRT. Patients also undergo SNT and LWRT as in arm IB.
Procedure: therapeutic dietary intervention
Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction.
Adfærdsmæssigt: exercise intervention
Patients undergo low weight resistance training.
Medicin: amifostine trihydrate
Given subcutaneously
Andre navne:
  • Ethyol

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Patients With Each Degree of Swallowing Dysfunction
Tidsramme: 6 months after concurrent chemotherapy and radiation
Grade of swallowing dysfunction as measured by the modified barium swallow score: grade 1, normal; grade 2, within functional limits; grade 3, mild impairment; grade 4, mild to moderate impairment; grade 5, moderate impairment; grade 6, moderate to severe impairment; grade 7, severe impairment
6 months after concurrent chemotherapy and radiation

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Stimulated and Unstimulated Salivary Production
Tidsramme: 6 months after concurrent chemotherapy and radiation
Unstimulated and stimulated salivary production, measured in mL/minute. Unstimulated salivary production is determined by expectoration of passively accumulated secretions accumulated in three 2-minute periods. Stimulated salivary production is determined by chewing paraffin wax with expectoration of passively accumulated secretions accumulated in three 2-minute periods.
6 months after concurrent chemotherapy and radiation
Number of Patients With Oral Mucositis by Grade
Tidsramme: 6 months after concurrent chemotherapy and radiation
Measured by Common Toxicity Criteria (CTC) v. 3.00 = no mucositis (minimum score), 1 = mild mucositis, 2 = moderate mucositis, 3 = severe mucositis, 4 = life-threatening, disabling mucositis, 5 = death (worst score).
6 months after concurrent chemotherapy and radiation
Changes in the Amount and Texture of Food Consumed
Tidsramme: at baseline, at 1 month, 3 months and 6 months post-chemoradiation
Patients are asked to note their food intake in terms of amount and texture over the past 24 hours as measured by 24-hour dietary recalls.
at baseline, at 1 month, 3 months and 6 months post-chemoradiation
Changes in the Frequency and Types of Dietary Intakes
Tidsramme: at baseline, at 1 month, 3 months and 6 months post-chemoradiation
Patients are asked to note their food intake in terms of amount and texture over the past 24 hours as measured by 24 hour dietary recalls.
at baseline, at 1 month, 3 months and 6 months post-chemoradiation

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Vanderbilt-Ingram Cancer Center

Samarbejdspartnere

National Cancer Institute (NCI)

Efterforskere

  • Studiestol: Barbara A. Murphy, MD, Vanderbilt-Ingram Cancer Center

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. januar 2006

Primær færdiggørelse (Faktiske)

1. august 2008

Studieafslutning (Faktiske)

1. august 2008

Datoer for studieregistrering

Først indsendt

17. juli 2007

Først indsendt, der opfyldte QC-kriterier

17. juli 2007

Først opslået (Skøn)

19. juli 2007

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

20. juni 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. maj 2017

Sidst verificeret

1. maj 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • VICC HN 0554
  • VU-VICC-HN-0554
  • VU-VICC-IRB-051068

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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