doxepin has been researched along with Mucositis, Oral in 8 studies
Doxepin: A dibenzoxepin tricyclic compound. It displays a range of pharmacological actions including maintaining adrenergic innervation. Its mechanism of action is not fully understood, but it appears to block reuptake of monoaminergic neurotransmitters into presynaptic terminals. It also possesses anticholinergic activity and modulates antagonism of histamine H(1)- and H(2)-receptors.
doxepin : A dibenzooxepine that is 6,11-dihydrodibenzo[b,e]oxepine substituted by a 3-(dimethylamino)propylidene group at position 11. It is used as an antidepressant drug.
| Excerpt | Relevance | Reference |
|---|---|---|
| "To evaluate the effect of doxepin mouthwash or diphenhydramine-lidocaine-antacid mouthwash for the treatment of oral mucositis-related pain." | 9.30 | Effect of Doxepin Mouthwash or Diphenhydramine-Lidocaine-Antacid Mouthwash vs Placebo on Radiotherapy-Related Oral Mucositis Pain: The Alliance A221304 Randomized Clinical Trial. ( Curtis, A; Ko, SJ; Le-Rademacher, JG; Leenstra, JL; Loprinzi, CL; Martenson, JA; Miller, RC; Novotny, PJ; Qin, R; Reiter, PL; Rine, G; Singh, AK; Sio, TT; Tan, AD, 2019) |
| "This study describes the development of semisolid formulations containing doxepin (DOX) for pain relief in oral mucositis, frequently related to chemotherapy and/or radiotherapy treatments in patients with head and neck cancer." | 7.85 | Development of a buccal doxepin platform for pain in oral mucositis derived from head and neck cancer treatment. ( Calpena, AC; Clares, B; Gimeno, Á; Halbaut, L; Mallandrich, M; Sanz, R, 2017) |
| " The purpose of this study was to assess the impact of doxepin oral rinse in the management of oral mucosal pain in cancer patients." | 7.71 | Oral topical doxepin rinse: analgesic effect in patients with oral mucosal pain due to cancer or cancer therapy. ( Allison, C; Epstein, JB; Epstein, MS; Le, ND; Oien, H; Truelove, EL, 2001) |
| "To evaluate the effect of doxepin mouthwash or diphenhydramine-lidocaine-antacid mouthwash for the treatment of oral mucositis-related pain." | 5.30 | Effect of Doxepin Mouthwash or Diphenhydramine-Lidocaine-Antacid Mouthwash vs Placebo on Radiotherapy-Related Oral Mucositis Pain: The Alliance A221304 Randomized Clinical Trial. ( Curtis, A; Ko, SJ; Le-Rademacher, JG; Leenstra, JL; Loprinzi, CL; Martenson, JA; Miller, RC; Novotny, PJ; Qin, R; Reiter, PL; Rine, G; Singh, AK; Sio, TT; Tan, AD, 2019) |
| "This study describes the development of semisolid formulations containing doxepin (DOX) for pain relief in oral mucositis, frequently related to chemotherapy and/or radiotherapy treatments in patients with head and neck cancer." | 3.85 | Development of a buccal doxepin platform for pain in oral mucositis derived from head and neck cancer treatment. ( Calpena, AC; Clares, B; Gimeno, Á; Halbaut, L; Mallandrich, M; Sanz, R, 2017) |
| " The purpose of this study was to assess the impact of doxepin oral rinse in the management of oral mucosal pain in cancer patients." | 3.71 | Oral topical doxepin rinse: analgesic effect in patients with oral mucosal pain due to cancer or cancer therapy. ( Allison, C; Epstein, JB; Epstein, MS; Le, ND; Oien, H; Truelove, EL, 2001) |
| "Considering the prevalence of oral mucositis, we aimed to use the analgesic effects of doxepin with chitosan's antimicrobial and bio-adhesive nature to fabricate a nano-formulation for treating chemotherapy-induced oral mucositis." | 3.30 | A novel chitosan-based doxepin nano-formulation for chemotherapy-induced oral mucositis: a randomized, double-blinded, placebo-controlled clinical trial. ( Amanati, A; Gholami, A; Mardani, M; Rezaee, M; Samiraninezhad, N, 2023) |
| "Doxepin was associated with more stinging or burning, unpleasant taste, and greater drowsiness than the placebo rinse." | 2.79 | Doxepin rinse versus placebo in the treatment of acute oral mucositis pain in patients receiving head and neck radiotherapy with or without chemotherapy: a phase III, randomized, double-blind trial (NCCTG-N09C6 [Alliance]). ( Bearden, JD; Dornfeld, KJ; Foote, RL; Klish, MD; Leenstra, JL; Loprinzi, CL; Martenson, JA; Mazurczak, MA; Miller, RC; Novotny, PJ; Puri, DR; Qin, R; Stella, PJ, 2014) |
| Timeframe | Studies, this research(%) | All Research% |
|---|---|---|
| pre-1990 | 1 (12.50) | 18.7374 |
| 1990's | 0 (0.00) | 18.2507 |
| 2000's | 2 (25.00) | 29.6817 |
| 2010's | 4 (50.00) | 24.3611 |
| 2020's | 1 (12.50) | 2.80 |
| Authors | Studies |
|---|---|
| Samiraninezhad, N | 1 |
| Rezaee, M | 1 |
| Gholami, A | 1 |
| Amanati, A | 1 |
| Mardani, M | 1 |
| Sanz, R | 1 |
| Calpena, AC | 1 |
| Mallandrich, M | 1 |
| Gimeno, Á | 1 |
| Halbaut, L | 1 |
| Clares, B | 1 |
| Elad, S | 1 |
| Yarom, N | 1 |
| Sio, TT | 1 |
| Le-Rademacher, JG | 1 |
| Leenstra, JL | 2 |
| Loprinzi, CL | 2 |
| Rine, G | 1 |
| Curtis, A | 1 |
| Singh, AK | 1 |
| Martenson, JA | 2 |
| Novotny, PJ | 2 |
| Tan, AD | 1 |
| Qin, R | 2 |
| Ko, SJ | 1 |
| Reiter, PL | 1 |
| Miller, RC | 2 |
| Dornfeld, KJ | 1 |
| Bearden, JD | 1 |
| Puri, DR | 1 |
| Stella, PJ | 1 |
| Mazurczak, MA | 1 |
| Klish, MD | 1 |
| Foote, RL | 1 |
| Epstein, JB | 2 |
| Epstein, JD | 1 |
| Epstein, MS | 2 |
| Oien, H | 2 |
| Truelove, EL | 2 |
| Salem, RB | 1 |
| Fischer, RG | 1 |
| Beghé, C | 1 |
| Allison, C | 1 |
| Le, ND | 1 |
| Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
|---|---|---|---|---|---|---|---|
| A Phase 1/Phase 2 Study for the Prevention of Oral Mucositis (SPOM)[NCT05338398] | Phase 1/Phase 2 | 100 participants (Anticipated) | Interventional | 2022-04-15 | Enrolling by invitation | ||
| Opioid Therapy vs Multimodal Analgesia in Head and Neck Cancer: A Randomized Clinical Trial[NCT04221165] | Phase 2 | 62 participants (Anticipated) | Interventional | 2020-08-04 | Recruiting | ||
| A Randomized Study of a New Medical Device for Oral Mucositis (MDOM Trial)[NCT05104268] | Phase 1/Phase 2 | 100 participants (Anticipated) | Interventional | 2021-11-30 | Not yet recruiting | ||
| A Phase III Placebo-Controlled, Randomized Three-Arm Study of Doxepin and a Topical Rinse in the Treatment of Acute Oral Mucositis Pain in Patients Receiving Radiotherapy With or Without Chemotherapy[NCT02229539] | Phase 3 | 275 participants (Actual) | Interventional | 2014-11-30 | Completed | ||
| A Randomized Double-Blind Study of Doxepin Rinse Versus Placebo in the Treatment of Acute Oral Mucositis Pain in Patients Receiving Radiotherapy With or Without Chemotherapy[NCT01156142] | Phase 3 | 155 participants (Actual) | Interventional | 2010-12-31 | Completed | ||
| Comparison of Controlled-release Oxycodone to Control Chemoradiotherapy-induced Moderate or Severe Oral Mucositis Pain in Nasopharyngeal Carcinoma Patients[NCT03045484] | 70 participants (Anticipated) | Interventional | 2016-05-31 | Recruiting | |||
| [information is prepared from clinicaltrials.gov, extracted Sep-2024] | |||||||
Total pain reduction (mouth and throat) was measured by the numerical analogue scale of mouth pain on a scale of 0 to 10, with 0=no pain and 10=worst pain in the questionnaires taken at baseline, and 5, 15, 30, 60, 120, 240 minutes after assigned treatment for doxepin or DLA vs. placebo. The total pain reduction was calculated by the (average of mouth and throat) area under the curve (AUC) adjusting for baseline, with time scale (baseline, 5, 15, 30, 60, 120 and 240 minutes post treatment) replaced by a numerical scale of 0, 1, 2, 3, 4, 5 and 6 respectively. The AUC was prorated when there are terminal missing data. If the missing data were intermittent, simple imputation by trapezoidal rules were applied to calculate the AUC. If a patient cancelled, was missing baseline data, or only provided baseline data, he/she was excluded from the statistical analysis. (NCT02229539)
Timeframe: Baseline, 5, 15, 30, 60, 120, 240 minutes post treatment
| Intervention | units on a scale*time scale (Mean) |
|---|---|
| Doxepin | 11.9 |
| DLA (Diphenhydramine, Lidocaine and Antacid) | 11.7 |
| Placebo | 8.7 |
After each dose was administered, patients were asked if they would like to continue rinses with that particular agent. The percentage of patients who expressed an interest in continuing therapy are reported below. (NCT01156142)
Timeframe: Up to 9 days
| Intervention | percentage of patients (Number) |
|---|---|
| Arm I (Doxepin-Placebo) | 77.3 |
| Arm II (Placebo-Doxepin) | 51.5 |
The total drowsiness increase will be calculated by the area under the curve (AUC) adjusting for baseline, with time scale replaced by a numerical scale of 1,2,3,4,5,6. The numerical scale will be used rather than the raw time scale in order to give proper weights to more immediate patient-reported mouth pain outcomes after treatment. The AUC will be calculated by proration when there are terminal missing data. If the missing data are intermittent, simple imputation will be applied to calculate the AUC. The question ('On a scale from 0 to 10, what number best describes your DROWSINESS now?') used 11-point numerical analog scales (0 (no drowsiness) to 10 (extreme drowsiness, leading to sleep) scores) to measure total drowsiness increase. The AUCs for the two treatment arms were compared by using the Wilcoxon rank sum test with 95% CIs. The statistical analysis will be the same as the primary analysis. (NCT01156142)
Timeframe: Up to 9 days
| Intervention | units on a scale (Mean) |
|---|---|
| Arm I (Doxepin-Placebo) | -0.7 |
| Arm II (Placebo-Doxepin) | -2.4 |
The total pain reduction will be calculated by the (average of mouth and throat) area under the curve (AUC) adjusting for baseline, with time scale replaced by a numerical scale of 1,2,3,4,5,6. The numerical scale will be used rather than the raw time scale in order to give proper weights to more immediate patient-reported mouth pain outcomes after treatment. The AUC will be calculated by proration when there are terminal missing data. If the missing data are intermittent, simple imputation will be applied to calculate the AUC. The question ('On a scale from 0 to 10, what number best describes your MOUTH PAIN due to your radiation treatment now?') used 11-point numerical analog scales (0 (no pain) to 10 (worst pain imaginable or possible) scores) to measure pain. The AUCs for the two treatment arms were compared by using the Wilcoxon rank sum test with 95% CIs. (NCT01156142)
Timeframe: Baseline and Day 1
| Intervention | units on a scale (Mean) |
|---|---|
| Arm I (Doxepin-Placebo) | -9.1 |
| Arm II (Placebo-Doxepin) | -4.7 |
The total stinging or burning from the oral rinse will be calculated by the area under the curve (AUC) adjusting for baseline, with time scale replaced by a numerical scale of 1,2,3,4,5,6. The numerical scale will be used rather than the raw time scale in order to give proper weights to more immediate patient-reported mouth pain outcomes after treatment. The AUC will be calculated by proration when there are terminal missing data. If the missing data are intermittent, simple imputation will be applied to calculate the AUC. The question ('On a scale from 0 to 10, what number best describes any STINGING OR BURNING FROM THE ORAL RINSE now?') used 11-point numerical analog scales (0 (no stinging or burning) to 10 (worst stinging or burning possible) scores) to total stinging or burning from the oral rinse. The AUCs for the two treatment arms were compared by using the Wilcoxon rank sum test with 95% CIs.The statistical analysis will be the same as the primary analysis. (NCT01156142)
Timeframe: Up to 9 days
| Intervention | units on a scale (Mean) |
|---|---|
| Arm I (Doxepin-Placebo) | 9.6 |
| Arm II (Placebo-Doxepin) | 4.0 |
The total taste of the oral rinse will be calculated by the area under the curve (AUC) adjusting for baseline, with time scale replaced by a numerical scale of 1,2,3,4,5,6 , and analyzed in the same way as the primary endpoint. The numerical scale will be used rather than the raw time scale in order to give proper weights to more immediate patient-reported mouth pain outcomes after treatment. The AUC will be calculated by proration when there are terminal missing data. If the missing data are intermittent, simple imputation will be applied to calculate the AUC. The question ('On a scale from 0 to 10, what number best describes the TASTE OF THE ORAL RINSE now?') used 11-point numerical analog scales (0 (acceptable taste) to 10(terrible taste), with higher values representing worse outcome) to evaluate the total taste of the oral rinse. The AUCs for the two treatment arms were compared by using the Wilcoxon rank sum test with 95% CIs. (NCT01156142)
Timeframe: Up to 9 days
| Intervention | units on a scale (Mean) |
|---|---|
| Arm I (Doxepin-Placebo) | 7.7 |
| Arm II (Placebo-Doxepin) | 5.1 |
The incidence of utilizing additional analgesics between 2 and 4 hours after the initial mouthwash will be compared between the arms by the Chi-square test . (NCT01156142)
Timeframe: Up to 9 days
| Intervention | percentage of patients (Number) | |
|---|---|---|
| At 2 hours after the initial mouthwash | At 4 hours after the initial mouthwash | |
| Arm I (Doxepin-Placebo) | 8.8 | 16.9 |
| Arm II (Placebo-Doxepin) | 2.9 | 14.5 |
4 trials available for doxepin and Mucositis, Oral
4 other studies available for doxepin and Mucositis, Oral
| Article | Year |
|---|---|
Development of a buccal doxepin platform for pain in oral mucositis derived from head and neck cancer treatment.
Topics: Animals; Doxepin; Female; Head and Neck Neoplasms; Histamine Antagonists; Male; Mouth Mucosa; Mouthw | 2017 |
The Search for an Effective Therapy and Pain Relief for Oral Mucositis.
Topics: Antacids; Diphenhydramine; Doxepin; Humans; Lidocaine; Mouthwashes; Pain; Stomatitis | 2019 |
The Search for an Effective Therapy and Pain Relief for Oral Mucositis.
Topics: Antacids; Diphenhydramine; Doxepin; Humans; Lidocaine; Mouthwashes; Pain; Stomatitis | 2019 |
The Search for an Effective Therapy and Pain Relief for Oral Mucositis.
Topics: Antacids; Diphenhydramine; Doxepin; Humans; Lidocaine; Mouthwashes; Pain; Stomatitis | 2019 |
The Search for an Effective Therapy and Pain Relief for Oral Mucositis.
Topics: Antacids; Diphenhydramine; Doxepin; Humans; Lidocaine; Mouthwashes; Pain; Stomatitis | 2019 |
Acute stomatitis associated with doxepin therapy.
Topics: Acute Disease; Adult; Doxepin; Female; Humans; Stomatitis | 1981 |
Oral topical doxepin rinse: analgesic effect in patients with oral mucosal pain due to cancer or cancer therapy.
Topics: Adult; Aged; Aged, 80 and over; Analgesics; Doxepin; Female; Head and Neck Neoplasms; Humans; Leukem | 2001 |