Clinical trial · Interventional
Chemo/XRT +/- Amifostine to Assess Outcomes Related to Xerostomia, Mucositis, & Dysphagia
Randomized Pilot Trial of Chemoradiation Plus or Minus Amifostine to Assess Potential Nutritional, Inflammatory and Physical Outcomes Related to Xerostomia, Mucositis and Dysphagia
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): funding became unavailable
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Dysphagia | — | UNRESOLVED | — |
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Mucositis | — | UNRESOLVED | — |
| Xerostomia | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| amifostine trihydrate | Drug | — | UNRESOLVED |
| exercise intervention | Behavioral | — | UNRESOLVED |
| therapeutic dietary intervention | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- ACTIVE_COMPARATOR
- label
- Arm IA
- description
- Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction.
- interventionNames
- Procedure: therapeutic dietary intervention
- type
- ACTIVE_COMPARATOR
- label
- Arm IB
- description
- Patients undergo SNT and low weight resistance training (LWRT).
- interventionNames
- Behavioral: exercise intervention
- Procedure: therapeutic dietary intervention
- type
- EXPERIMENTAL
- label
- Arm IIA
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available