A Phase 2/3 interventional study of Live Combined Bifidobacterium and Lactobacillus Tablets、Compound Glutamine Entersoluble capsules in Radiation Proctitis, Probiotics and Glutamine, sponsored by West China Hospital. Status unknown at 2 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-07-15.
Sponsored by West China Hospital · Phase 2/3, Interventional, and Prevention
Radiation proctitis is a common complication after radiation therapy for pelvic tumors. The investigators found that live bifidobacterium and lactobacillus tablets combined with compound glutamine enteric-coated capsules can significantly relieve the symptoms of radiation proctitis through preliminary clinical practice, but the mechanism is unknown. Through a prospective randomized controlled study, this study intends to investigate the incidence of grade 2 or higher acute radiation proctitis in patients of locally advanced rectal cancer after radiotherapy with the combined therapy. And through various scales, next-generation sequencing methods and other methods to evaluate the clinical symptoms, colonoscopy, imaging, and changes in the species and abundance of intestinal flora before and after treatment. To further explore the related pathways and mechanisms affecting radiation proctitis.
27 studies on the registry are indexed under Proctitis; 6 are open to participants now.
This study's planned enrollment of 176 is above the median of 122 across 23 interventional studies indexed under Proctitis.
Browse Proctitis studies →West China Hospital is the lead sponsor of 501 studies on the registry; 246 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
From the first day of chemoradiotherapy, live combined Bifidobacterium and Lactobacillus tablets(2000mg each time, 3 times/day) combined with compound glutamine enteric-coated capsules (3 capsules each time, 3 times/day) until 1 month after the end of chemoradiotherapy.
Drug: Live Combined Bifidobacterium and Lactobacillus Tablets、Compound Glutamine Entersoluble capsules
After the start of chemoradiotherapy, the control group don't take the experimental drug orally . When patients have radiation proctitis of grade ≥2, they would be crossed over to the combined treatment group：live combined Bifidobacterium and Lactobacillus tablets(2000mg each time, 3 times/day) combined with compound glutamine enteric-coated capsules (3 capsules each time, 3 times/day) until 1 month after the end of chemoradiotherapy.
Live Combined Bifidobacterium and Lactobacillus Tablets：probiotics. Compound Glutamine Entersoluble capsules：combined traditional Chinese medicine and glutamine
Also known as: Probiotics、Glutamine
Incidence of radiation proctitis
Incidence of grade ≥2 radiation proctitis in combination therapy group
Time frame: two months
remission rate of radiation proctitis
remission rate of radiation proctitis after combined treatment in control group developed radiation proctitis of grade ≥2
Time frame: two months
Evaluation of radiation proctitis by LENT SOMA Score
Evaluation of radiation proctitis with clinical symptoms using LENT SOMA Score.The minimum value is 0, and maximum is 4. Higher scores mean a worse outcome.
Time frame: two months
Evaluation of radiation proctitis by rectal chemoradiotherapy toxicity scale
Evaluation of radiation proctitis with clinical symptoms using rectal chemoradiotherapy toxicity scale.The minimum value is 0, and maximum is 5. Higher scores mean a worse outcome.
Time frame: two months
Evaluation of radiation proctitis by fiberoptic proctoscopy
Evaluation of radiation proctitis with fiberoptic proctoscopy using Vienna Rectoscopy Score. The minimum value is 0, and maximum is 3/4. Higher scores mean a worse outcome.
Time frame: two months
changes in gut microbiota by 16S rRNA sequencing technology
To detect changes in gut microbiota with 16S rRNA sequencing，including changes in species diversity and abundance of gut microbiota.
Time frame: two months
Changes in serum inflammatory factors
Assess changes in serum inflammatory factors , including IL-2、IL-6，CRP、TNFa, etc.
Time frame: two months
QOL C29
Assess patients' subjective feeling of life using EORTC QOL C29.The minimum value is 1, and maximum is 4. Higher scores mean a worse outcome.
Time frame: two months
QOL C30
Assess patients' subjective feeling of life using EORTC QOL C30.The minimum value is 1, and maximum is 4. Higher scores mean a worse outcome.
Time frame: two months
tumor imaging assessment
Evaluation of tumor changes with imaging methods，including treatment response with complete response, partial response or stable disease according to RECIST 1.1 after 1 month after concurrent chemoradiotherapy.
Time frame: two months
This study is status unknown, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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