Dataset Information

Minocycline for symptom reduction during radiation therapy for head and neck cancer: a randomized clinical trial.

ABSTRACT:

Purpose

Local/systemic symptoms during cancer therapy may be exacerbated by dysregulated inflammation and its downstream toxic effects. Minocycline can suppress proinflammatory cytokine release; therefore, we investigated its potential to reduce patient-reported symptom severity during radiotherapy (RT) for head and neck cancer (HNC).

Methods

Eligible patients for this blinded, placebo-controlled trial were adults with T0-3, N-any, and M0 HNC receiving single-modality RT. Participants were randomized 1:1 to either minocycline (200 mg/day) or placebo during RT. The primary endpoint was the area under the curve (AUC) of 5 prespecified symptoms (pain, fatigue, disturbed sleep, poor appetite, difficulty swallowing/chewing) during RT, assessed with the MD Anderson Symptom Inventory for HNC (MDASI-HN).

Results

We analyzed data from 20 evaluable patients per arm. Overall, 75% had oropharyngeal cancer and 78% were male. No grade 3+ adverse events potentially related to study medication were observed. Two minocycline patients required a feeding tube during RT vs 5 placebo patients (P?=?0.21). The average daily AUC during RT for the 5 MDASI-HN symptoms was 3.1 (SD?=?1.0) for minocycline and 3.7 (SD?=?1.7) for placebo (P?=?0.16); the 0.37 effect size was less than our 0.70 target. AUC comparisons for several individual symptoms and symptom interference favored minocycline but were not statistically significant. The greatest numerical differences occurred for systemic symptoms, larger toward treatment end, and in early post-RT recovery.

Conclusions

Minocycline was feasible, well tolerated, and achieved a positive signal toward reducing patient-reported symptom severity during RT for HNC, particularly for systemic symptoms. This justifies additional study and informs future trial design.

SUBMITTER: Gunn GB

PROVIDER: S-EPMC7470188 | biostudies-literature | 2020 Jan

REPOSITORIES: biostudies-literature

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Publications

Minocycline for symptom reduction during radiation therapy for head and neck cancer: a randomized clinical trial.

Gunn G Brandon GB Mendoza Tito R TR Garden Adam S AS Wang Xin Shelley XS Shi Qiuling Q Morrison William H WH Frank Steven J SJ Phan Jack J Fuller Clifton D CD Chambers Mark S MS Hanna Ehab Y EY Lu Charles C Rosenthal David I DI Cleeland Charles S CS

Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer 20190429 1

<h4>Purpose</h4>Local/systemic symptoms during cancer therapy may be exacerbated by dysregulated inflammation and its downstream toxic effects. Minocycline can suppress proinflammatory cytokine release; therefore, we investigated its potential to reduce patient-reported symptom severity during radiotherapy (RT) for head and neck cancer (HNC).<h4>Methods</h4>Eligible patients for this blinded, placebo-controlled trial were adults with T0-3, N-any, and M0 HNC receiving single-modality RT. Particip ...[more]

PMID: 31037378

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Dataset Information

Minocycline for symptom reduction during radiation therapy for head and neck cancer: a randomized clinical trial.

Purpose

Methods

Results

Conclusions

Publications

Minocycline for symptom reduction during radiation therapy for head and neck cancer: a randomized clinical trial.

Similar Datasets

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