Soylent in Reducing Gastrostomy Tube Rates in Patients With Locally Advanced Head and Neck Cancer… (NCT07242365) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Soylent in Reducing Gastrostomy Tube Rates in Patients With Locally Advanced Head and Neck Cancer Undergoing Chemoradiotherapy
United States60 participantsStarted 2017-06-19
Plain-language summary
This phase II trial studies Soylent in reducing gastrostomy tube rates in patients with head and neck cancer that has spread to nearby tissues or lymph nodes (locally advanced) who are undergoing chemoradiotherapy. Soylent is a liquid meal replacement product that may reduce the risk of malnutrition and gastrostomy placement during or following treatment for head and neck cancer with chemoradiation.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Documented locally advanced head and neck malignancies for which concurrent chemoradiation has been recommended for definitive or adjuvant treatment
* No history of prior radiotherapy to the head and neck; however, if previous treatment was superficial skin radiotherapy without regional lymph node treatment this will be allowed
* Karnofsky performance status (KPS) \>= 70
* Body mass index \>= 18 kg/m\^2
* No evidence of metastatic disease (M1 disease)
* No G-tube placement prior to initiation of chemoradiation
* Eligible to undergo concurrent chemotherapy as determined by treating medical oncologist
* If a woman is of childbearing potential, a negative serum pregnancy test must be documented prior to proceeding with chemoradiation; women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; or abstinence) for at least 4 weeks after study treatment
* Ability to understand and willingness to sign a written informed consent
* Able to tolerate the taste of one of the flavors of the oral nutritional supplement Soylent
* Able and willing to participate in the Swallow Preservation Program at the Speech Pathology Clinic
* No evidence of clinically significant swallowing dysfunction by history or physical exam at time of radiation oncology consultation
Exclusion Criteria:
* Patients who have previously received therapeutic radiation therapy to the head and neck except for superficial skin radiotherapy …
What they're measuring
1
Compliance with Soylent nutritional supplementation