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Published in: Journal of Gastrointestinal Cancer 2/2022

22-02-2021 | Proctitis | Original Research

Aloe vera for Prevention of Acute Radiation Proctitis in Colorectal Cancer a Preliminary Randomized, Placebo-Controlled Clinical Trial

Authors: Adeleh Sahebnasagh, Fatemeh Saghafi, Arash Ghasemi, Jafar Akbari, Abbas Alipour, Solomon Habtemariam, Mohammadreza Safdari, Hassan Rezai Ghaleno, Ebrahim Salehifar

Published in: Journal of Gastrointestinal Cancer | Issue 2/2022

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Abstract

Objective

To examine the preventive effects of Aloe vera in colorectal cancer patients undergoing radiotherapy.

Material and Method

Twenty colorectal cancer patients, who received radiation, were randomized to receive Aloe vera 3% or placebo ointment, 1 g twice daily for 6 weeks. At weekly visits, acute radiation proctitis (ARP) was evaluated by Radiation Therapy Oncology Group and clinical presentation criteria as the primary endpoint. We also evaluated secondary endpoints of quality of life, psychosocial status, by applying Hospital Anxiety-Depression (HAD) Scale and laboratory measures of quantitative measurement of C-reactive protein (CRP) as a marker for systemic inflammation.

Results

There was a significant improvement in the symptom index (before treatment vs. after treatment with Aloe vera) for diarrhea (p = 0.029, median score: 0.5 vs. 0.001). The overall primary and secondary outcomes favored Aloe group, while the measures of toxicity did not achieve a statistical significant difference. The lifestyle score improved significantly with A. vera (p = 004), and they also had a lower depression score in HAD scale (p = 0.008). Furthermore, quantitative CRP decreased significantly during the course of treatment with Aloe vera.

Conclusion

The use of topical formulation of Aloe vera 3% diminishes the severity of ARP in colorectal cancer patients.
Literature
1.
go back to reference Richardson J, Smith JE, McIntyre M, Thomas R, Pilkington K. Aloe vera for preventing radiation-induced skin reactions: a systematic literature review. Clin Oncol. 2005;17(6):478–84.CrossRef Richardson J, Smith JE, McIntyre M, Thomas R, Pilkington K. Aloe vera for preventing radiation-induced skin reactions: a systematic literature review. Clin Oncol. 2005;17(6):478–84.CrossRef
2.
go back to reference Sahebnasagh A, Ghasemi A, Akbari J, Alipour A, Lashkardoost H, Ala S, et al. Successful treatment of acute radiation proctitis with Aloe vera: a preliminary randomized controlled clinical trial. J Altern Complement Med. 2017;23(11):858–65.CrossRef Sahebnasagh A, Ghasemi A, Akbari J, Alipour A, Lashkardoost H, Ala S, et al. Successful treatment of acute radiation proctitis with Aloe vera: a preliminary randomized controlled clinical trial. J Altern Complement Med. 2017;23(11):858–65.CrossRef
3.
go back to reference Sahebnasagh A, Ghasemi A, Akbari J, Alipour A, Lashkardoost H, Ala S, et al. Prevention of acute radiation-induced Proctitis by Aloe vera: a prospective randomized, double-blind, placebo controlled clinical trial in pelvic cancer patients. BMC Complement Med Ther. 2020;20:1–9.CrossRef Sahebnasagh A, Ghasemi A, Akbari J, Alipour A, Lashkardoost H, Ala S, et al. Prevention of acute radiation-induced Proctitis by Aloe vera: a prospective randomized, double-blind, placebo controlled clinical trial in pelvic cancer patients. BMC Complement Med Ther. 2020;20:1–9.CrossRef
4.
go back to reference Sahu PK, Giri DD, Singh R, Pandey P, Gupta S, Shrivastava AK, et al. Therapeutic and medicinal uses of Aloe vera: a review. Pharmacol & Pharm. 2013;4(08):599.CrossRef Sahu PK, Giri DD, Singh R, Pandey P, Gupta S, Shrivastava AK, et al. Therapeutic and medicinal uses of Aloe vera: a review. Pharmacol & Pharm. 2013;4(08):599.CrossRef
5.
go back to reference Kennedy M, Bruninga K, Mutlu EA, Losurdo J, Choudhary S, Keshavarzian A. Successful and sustained treatment of chronic radiation proctitis with antioxidant vitamins E and C. Am J Gastroenterol. 2001;96(4):1080–4.CrossRef Kennedy M, Bruninga K, Mutlu EA, Losurdo J, Choudhary S, Keshavarzian A. Successful and sustained treatment of chronic radiation proctitis with antioxidant vitamins E and C. Am J Gastroenterol. 2001;96(4):1080–4.CrossRef
6.
go back to reference Denton A, Andreyev H, Forbes A, Maher E. Systematic review for non-surgical interventions for the management of late radiation proctitis. Br J Cancer. 2002;87(2):134.CrossRef Denton A, Andreyev H, Forbes A, Maher E. Systematic review for non-surgical interventions for the management of late radiation proctitis. Br J Cancer. 2002;87(2):134.CrossRef
7.
go back to reference Widmark A, Fransson P, Tavelin B. Self-assessment questionnaire for evaluating urinary and intestinal late side effects after pelvic radiotherapy in patients with prostate cancer compared with an age-matched control population. Cancer. 1994;74(9):2520–32.CrossRef Widmark A, Fransson P, Tavelin B. Self-assessment questionnaire for evaluating urinary and intestinal late side effects after pelvic radiotherapy in patients with prostate cancer compared with an age-matched control population. Cancer. 1994;74(9):2520–32.CrossRef
8.
go back to reference Saei S, Sahebnasagh A, Ghasemi A, Akbari J, Yaghobi Joybari A, Nejad Dadgar F, et al. Efficacy of sucralfate ointment in prevention of acute proctitis in cancer patients: a randomized controlled clinical trial. Caspian J Intern Med 2020; 11(4): 410-418. Saei S, Sahebnasagh A, Ghasemi A, Akbari J, Yaghobi Joybari A, Nejad Dadgar F, et al. Efficacy of sucralfate ointment in prevention of acute proctitis in cancer patients: a randomized controlled clinical trial. Caspian J Intern Med 2020; 11(4): 410-418.
9.
go back to reference Majumdar SR, Fletcher RH, Evans AT. How does colorectal cancer present? Symptoms, duration, and clues to location. Am J Gastroenterol. 1999;94(10):3039–45. Majumdar SR, Fletcher RH, Evans AT. How does colorectal cancer present? Symptoms, duration, and clues to location. Am J Gastroenterol. 1999;94(10):3039–45.
10.
go back to reference Cappell MS. Pathophysiology, clinical presentation, and management of colon cancer. Gastroenterol Clin. 2008;37(1):1–24.CrossRef Cappell MS. Pathophysiology, clinical presentation, and management of colon cancer. Gastroenterol Clin. 2008;37(1):1–24.CrossRef
11.
go back to reference Colorectal CCG. Adjuvant radiotherapy for rectal cancer: a systematic overview of 8,507 patients from 22 randomised trials. 2001. Colorectal CCG. Adjuvant radiotherapy for rectal cancer: a systematic overview of 8,507 patients from 22 randomised trials. 2001.
12.
go back to reference Johnston M, Robertson G, Frizelle F. Management of late complications of pelvic radiation in the rectum and anus. Dis Colon Rectum. 2003;46(2):247–59.CrossRef Johnston M, Robertson G, Frizelle F. Management of late complications of pelvic radiation in the rectum and anus. Dis Colon Rectum. 2003;46(2):247–59.CrossRef
13.
go back to reference Lee WR, Hanks GE, Hanlon AL, Schultheiss TE, Hunt MA. Lateral rectal shielding reduces late rectal morbidity following high dose three-dimensional conformal radiation therapy for clinically localized prostate cancer: further evidence for a significant dose effect. Int J Radiat Oncol Biology Physics. 1996;35(2):251–7. Lee WR, Hanks GE, Hanlon AL, Schultheiss TE, Hunt MA. Lateral rectal shielding reduces late rectal morbidity following high dose three-dimensional conformal radiation therapy for clinically localized prostate cancer: further evidence for a significant dose effect. Int J Radiat Oncol Biology Physics. 1996;35(2):251–7.
14.
go back to reference Sarin A, Safar B. Management of radiation proctitis. Gastroenterology Clinics. 2013;42(4):913–25.CrossRef Sarin A, Safar B. Management of radiation proctitis. Gastroenterology Clinics. 2013;42(4):913–25.CrossRef
15.
go back to reference Staffurth J. A review of the clinical evidence for intensity-modulated radiotherapy. Clin Oncol. 2010;22(8):643–57.CrossRef Staffurth J. A review of the clinical evidence for intensity-modulated radiotherapy. Clin Oncol. 2010;22(8):643–57.CrossRef
16.
go back to reference Singh AK, Ménard C, Guion P, Simone NL, Smith S, Crouse NS, et al. Intrarectal amifostine suspension may protect against acute proctitis during radiation therapy for prostate cancer: a pilot study. Int J Radiat Oncol Biology Physics. 2006;65(4):1008–13. Singh AK, Ménard C, Guion P, Simone NL, Smith S, Crouse NS, et al. Intrarectal amifostine suspension may protect against acute proctitis during radiation therapy for prostate cancer: a pilot study. Int J Radiat Oncol Biology Physics. 2006;65(4):1008–13.
17.
go back to reference Kouloulias VE, Kouvaris JR, Pissakas G, Mallas E, Antypas C, Kokakis JD, et al. Phase II multicenter randomized study of amifostine for prevention of acute radiation rectal toxicity: topical intrarectal versus subcutaneous application. Int J Radiat Oncol Biology Physics. 2005; 62(2):486–93. Kouloulias VE, Kouvaris JR, Pissakas G, Mallas E, Antypas C, Kokakis JD, et al. Phase II multicenter randomized study of amifostine for prevention of acute radiation rectal toxicity: topical intrarectal versus subcutaneous application. Int J Radiat Oncol Biology Physics. 2005; 62(2):486–93.
18.
go back to reference Najafi M, Motevaseli E, Shirazi A, Geraily G, Rezaeyan A, Norouzi F, et al. Mechanisms of inflammatory responses to radiation and normal tissues toxicity: clinical implications. Int J Radiat Biol. 2018;94(4):335–56. Najafi M, Motevaseli E, Shirazi A, Geraily G, Rezaeyan A, Norouzi F, et al. Mechanisms of inflammatory responses to radiation and normal tissues toxicity: clinical implications. Int J Radiat Biol. 2018;94(4):335–56.
19.
go back to reference Rafati M, Ghasemi A, Saeedi M, Habibi E, Salehifar E, Mosazadeh M, et al. Nigella sativa L. for Prevention of acute radiation dermatitis in breast cancer: a randomized, double-blind, placebo-controlled, clinical trial. Complement Med Ther. 2019:102205. Rafati M, Ghasemi A, Saeedi M, Habibi E, Salehifar E, Mosazadeh M, et al. Nigella sativa L. for Prevention of acute radiation dermatitis in breast cancer: a randomized, double-blind, placebo-controlled, clinical trial. Complement Med Ther. 2019:102205.
20.
go back to reference Ahmadi A. Potential prevention: Aloe vera mouthwash may reduce radiation-induced oral mucositis in head and neck cancer patients. Chin J Integr Med. 2012;18(8):635–40.CrossRef Ahmadi A. Potential prevention: Aloe vera mouthwash may reduce radiation-induced oral mucositis in head and neck cancer patients. Chin J Integr Med. 2012;18(8):635–40.CrossRef
21.
go back to reference Paulsen E, Korsholm L, Brandrup F. A double-blind, placebo-controlled study of a commercial Aloe vera gel in the treatment of slight to moderate psoriasis vulgaris. J Eur Acad Dermatol Venereol. 2005;19(3):326–31.CrossRef Paulsen E, Korsholm L, Brandrup F. A double-blind, placebo-controlled study of a commercial Aloe vera gel in the treatment of slight to moderate psoriasis vulgaris. J Eur Acad Dermatol Venereol. 2005;19(3):326–31.CrossRef
22.
go back to reference Maenthaisong R, Chaiyakunapruk N, Niruntraporn S, Kongkaew C. The efficacy of aloe vera used for burn wound healing: a systematic review. burns. 2007;33(6):713–8. Maenthaisong R, Chaiyakunapruk N, Niruntraporn S, Kongkaew C. The efficacy of aloe vera used for burn wound healing: a systematic review. burns. 2007;33(6):713–8.
23.
go back to reference Di Franco R, Sammarco E, Calvanese MG, De Natale F, Falivene S, DiLecce A, et al. Preventing the acute skin side effects in patients treated with radiotherapy for breast cancer: the use of corneometry in order to evaluate the protective effect of moisturizing creams. Radiat Oncol. 2013;8(1):57. Di Franco R, Sammarco E, Calvanese MG, De Natale F, Falivene S, DiLecce A, et al. Preventing the acute skin side effects in patients treated with radiotherapy for breast cancer: the use of corneometry in order to evaluate the protective effect of moisturizing creams. Radiat Oncol. 2013;8(1):57.
24.
go back to reference Puataweepong P, Dhanachai M, Dangprasert S, Sithatani C, Sawangsilp T, Narkwong L, et al. The efficacy of oral Aloe vera juice for radiation induced mucositis in head and neck cancer patients: a double-blind placebo-controlled study. Asian Biomed. 2010;3(4):375–82. Puataweepong P, Dhanachai M, Dangprasert S, Sithatani C, Sawangsilp T, Narkwong L, et al. The efficacy of oral Aloe vera juice for radiation induced mucositis in head and neck cancer patients: a double-blind placebo-controlled study. Asian Biomed. 2010;3(4):375–82.
25.
go back to reference Di Franco R, Sammarco E, Calvanese MG, De Natale F, Falivene S, DiLecce A, et al. Preventing the acute skin side effects in patients treated with radiotherapy for breast cancer: the use of corneometry in order to evaluate the protective effect of moisturizing creams. Radiat Oncol. 2013;8(1):57. Di Franco R, Sammarco E, Calvanese MG, De Natale F, Falivene S, DiLecce A, et al. Preventing the acute skin side effects in patients treated with radiotherapy for breast cancer: the use of corneometry in order to evaluate the protective effect of moisturizing creams. Radiat Oncol. 2013;8(1):57.
26.
go back to reference Levinson SS, Elin RJ. What is C-reactive protein telling us about coronary artery disease? Arch Intern Med. 2002;162(4):389–92.CrossRef Levinson SS, Elin RJ. What is C-reactive protein telling us about coronary artery disease? Arch Intern Med. 2002;162(4):389–92.CrossRef
Metadata
Title
Aloe vera for Prevention of Acute Radiation Proctitis in Colorectal Cancer a Preliminary Randomized, Placebo-Controlled Clinical Trial
Authors
Adeleh Sahebnasagh
Fatemeh Saghafi
Arash Ghasemi
Jafar Akbari
Abbas Alipour
Solomon Habtemariam
Mohammadreza Safdari
Hassan Rezai Ghaleno
Ebrahim Salehifar
Publication date
22-02-2021
Publisher
Springer US
Published in
Journal of Gastrointestinal Cancer / Issue 2/2022
Print ISSN: 1941-6628
Electronic ISSN: 1941-6636
DOI
https://doi.org/10.1007/s12029-021-00597-y

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