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Can planned IV fluids tame the brutal side effects of head and neck cancer treatment?

NCT ID NCT07784855

Symptom relief Sponsor: West Virginia University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 25, 2026 · Last updated Aug 26, 2026 · Updated 1 time

Summary

This trial tests whether giving IV fluids on a fixed schedule during chemoradiation for head and neck cancer can reduce severe side effects like mouth sores, swallowing problems, and kidney injury. Half of the participants will receive IV fluids twice a week starting in week 3 of treatment, while the other half will get fluids only when their doctor decides they need them. The goal is to see if planned hydration helps patients tolerate treatment better.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Scheduled intravenous (IV) hydration with normal saline (0.9% sodium chloride)
What this could lead to
If scheduled IV fluids reduce severe side effects, this could become a standard supportive care approach to help patients complete chemoradiation with fewer complications.
What could go wrong
This is a randomized trial, but the benefit is uncertain. Extra IV fluids may not reduce side effects and could carry risks like fluid overload or electrolyte imbalances.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 180 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Apr 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * ECOG 0-2 * Non-nasopharyngeal squamous cell carcinoma of oral cavity, oropharynx, hypopharynx, larynx primary * Planned for concurrent chemoradiotherapy (CCRT) with standard-of-care cisplatin-based regimen (IV cisplatin 100mg/m2 once every three weeks for up to three doses or IV cisplatin 40mg/m2 weekly) with concurrent radiotherapy (treatment duration approximately 6-7 weeks, per institutional standards). * The use of immunotherapy in combination with CCRT is permitted and does not affect eligibility or group assignment. Exclusion Criteria: * Nasopharyngeal squamous cell carcinomas, nasal cavity and paranasal sinus squamous cell carcinomas. * History of congestive heart failure. * Dependency on enteral nutrition and hydration prior to enrollment. * Use of diuretics that cannot be safely held during study treatment (participants who are able to temporarily discontinue diuretics during treatment are eligible).

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Conditions

The condition(s) this trial relates to.

hypopharynx squamous cell carcinoma laryngeal squamous cell carcinoma oral cavity squamous cell carcinoma oropharynx squamous cell carcinoma Squamous Cell Carcinoma of Head and Neck

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Squamous cell carcinoma of hypopharynx Squamous cell carcinoma of larynx Squamous cell carcinoma of oral cavity Squamous cell carcinoma of oropharynx

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    6 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • WVU Medicine Berkeley Medical Center

    Martinsburg, West Virginia, 25401, United States

  • WVU Medicine Camden Clark Medical Center

    Parkersburg, West Virginia, 26101, United States

  • WVU Medicine Princeton Community Hospital

    Princeton, West Virginia, 24740, United States

  • WVU Medicine United Hospital Center

    Bridgeport, West Virginia, 26330, United States

  • WVU Medicine Wheeling Hospital

    Wheeling, West Virginia, 26003, United States

  • West Virginia University Cancer Institute

    Morgantown, West Virginia, 26506, United States

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