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NCT01219673 · ClinicalTrials.gov registry record · Phase 1

Symptom Burden in Head and Neck Cancer

A Phase 1 study, sponsored by M.D. Anderson Cancer Center.

Terminated
Registry status
Phase 1
Development phase
1
Enrollment target

NCT01219673: Clinical Trial Phase 1 study, sponsored by M.D. Anderson Cancer Center.

NCT01219673 is a Phase 1 study that was terminated before completion, run by M.D. Anderson Cancer Center. The registered enrollment target is 1 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01219673, a Phase 1 study, was terminated before completion, sponsored by M.D. Anderson Cancer Center.

TERMINATED
Registry status
Phase 1
Development phase
1 participants
Enrollment target

Study Summary

The goal of this clinical research study is to compare armodafinil, bupropion, and minocycline when given alone or in combination. Researchers want to learn about the safety and level of effectiveness of these drugs in controlling symptoms, such as the side effects of chemoradiation, when given to patients with head and neck cancer.

Primary Outcome

Treatments ability to reduce values of 5 symptoms comprised of MD Anderson Symptom Inventory (MDASI)-Head and Neck Cancer (HNC) scores for fatigue, difficulty swallowing, sleep disturbance, pain, and lack of appetite collected during the 10 weeks of chemoradiation treatment. symptoms that are caused by their disease or by their treatment. Symptom severity score is comprised of average of the five above MDASI core items (fatigue, difficulty swallowing, sleep disturbance, pain, and lack of appetit

Interventions

  • OTHER Placebo
  • DRUG Bupropion
  • DRUG Minocycline
  • DRUG Armodafinil

Trial Details

FieldValue
Enrollment Target 1 participants
Start Date 2013-03
Est. Completion 2014-01
Phase Phase 1
M.D. Anderson Cancer Center

2,692 total trials

Why NCT01219673 stopped before completion

NCT01219673 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% lower).

The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.

NCT01219673 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01219673 about?

NCT01219673 is a clinical study titled "Symptom Burden in Head and Neck Cancer". The goal of this clinical research study is to compare armodafinil, bupropion, and minocycline when given alone or in combination. Researchers want to learn about the safety and level of effectiveness of these drugs in controlling symptoms, such as the side effects of chemoradiation, when given to p...

What is the current status of trial NCT01219673?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 1 participants. The study started on 2013-03. Estimated completion is 2014-01.

What interventions are being tested in trial NCT01219673?

The interventions under investigation include: Placebo (OTHER), Bupropion (DRUG), Minocycline (DRUG), Armodafinil (DRUG).

Who is sponsoring clinical trial NCT01219673?

This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01219673's enrollment target sits among peer trials

1 2001st of 2000 the lowest of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01219673, the US trial registry maintained by the National Library of Medicine. NCT01219673 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.