Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2025-12-25 @ 9:26 PM
Study NCT ID:
NCT06123156
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-11-08
First Post:
2023-10-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Interest of Early Erectile Rehabilitation With Sildenafil After Radiotherapy and Proctectomy for Rectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012004', 'term': 'Rectal Neoplasms'}], 'ancestors': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068677', 'term': 'Sildenafil Citrate'}], 'ancestors': [{'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 188}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2028-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-03', 'studyFirstSubmitDate': '2023-10-26', 'studyFirstSubmitQcDate': '2023-11-03', 'lastUpdatePostDateStruct': {'date': '2023-11-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "the patient's response", 'timeFrame': '12 months postoperatively', 'description': 'A patient is defined as a responder by a score of at least 22 for the erectile function domain of the International Index of Erectile Function (IIEF), comprising the six IIEF questions relating to erection (Q1-Q5 and Q15).'}], 'secondaryOutcomes': [{'measure': 'IIEF erectile function domain score', 'timeFrame': 'Day 0, Month 1, Month 3, Month 6, Month 9, Month12', 'description': 'Mesure of IIEF erectile function domain score, comprising the six IIEF erectile function questions (Q1-Q5 andQ15) at D0, M1, M3, M6, M9 and M12'}, {'measure': 'International Index of Erectile Function (IIEF) global score', 'timeFrame': 'Day 0, Month 1, Month 3, Month 6, Month 9, Month 12', 'description': 'International Index of Erectile Function (IIEF) global score measured at D0, M1, M3, M6, M9 and M12'}, {'measure': 'Quality of life score', 'timeFrame': 'Day 0, Month 1, Month 3, Month 6, Month 9, Month 12', 'description': 'Mesure of quality of life score (EORTC QLQ - C30 and QLQ - CR29) at D0, M1, M3, M6, M9 and M12'}, {'measure': 'LARS score', 'timeFrame': 'Day 0, Month 1, Month 3, Month 6, Month 9, Month 12', 'description': 'LARS score measured at D0, M1, M3, M6, M9 and M12'}, {'measure': 'Fecal Continence Score', 'timeFrame': 'Day 0, Month 1, Month 3, Month 6, Month 9, Month 12', 'description': 'Fecal Continence Score (Wexner score) measured at D0, M1, M3, M6, M9 and M12'}, {'measure': 'Spontaneous erection evaluation', 'timeFrame': 'Month 1, Month 3, Month 6, Month 9, Month 12', 'description': 'Number of patients with spontaneous erections on treatment at M3, M6, M9 and without treatment at M1, and M12'}, {'measure': 'Benefits of psychological follow-up', 'timeFrame': 'after 10 months of treatment', 'description': 'The number of patients with or without regular psychological follow-up. A patient is defined as having regular follow-up if he/she visits a psychologist and/or psychiatrist once or twice a month.'}, {'measure': 'Compliance with treatment', 'timeFrame': 'after 10 months of treatment', 'description': 'Number of unused tablets during the study. The patient will be considered as non-compliant if pill-taking over the entire 10-month treatment period is \\<80%.'}, {'measure': 'Adverse and suspected adverse events', 'timeFrame': 'Month 1, Month 3, Month 6, Month 9, Month 12', 'description': 'Number of AEs and SAEs in each group at M1, M3, M6, M9 and M12'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rectal Cancer']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the efficacy of erectile rehabilitation with Sildenafil, in men treated with neoadjuvant proctectomy and radiotherapy for rectal cancer, in preventing long-term erectile dysfunction at 12 months post-operatively.', 'detailedDescription': 'Colorectal cancer is the third most common cancer in men in France, after lung and prostate cancer. Proctectomy (possibly preceded by radiotherapy) is the most effective treatment for this cancer, but erectile dysfunction (ED) is a frequent complication, even when the nerves are preserved during dissection, and has a major impact on the quality of life of operated men.\n\nThe cause of erectile dysfunction after rectal cancer surgery is usually neurological, due to intraoperative trauma to the autonomic nerves, while erectile dysfunction after radiotherapy is mainly vascular in origin, with damage to erectile tissue.\n\nSeveral risk factors for sexual dysfunction after rectal cancer surgery have been reported (age, neoadjuvant radiotherapy, type of resection, operative difficulties and complications, body image affected by protective stoma). On the other hand, surgical expertise may be a protective factor.\n\nIn the physiological condition, the nitric oxide released by the pelvic nerves causes an increase in cyclic guanosine monophosphate, which in turn causes smooth muscle cells relaxation and an influx of blood into the cavernous body, triggering and maintaining the erection.\n\nSimilar to prostatectomy, nerve damage can occur during proctectomy through stretching, heat, ischemia or inflammation; this nerve damage results in reduced nitric oxide production.\n\nEven in the absence of nerve damage, it has been demonstrated (in an animal model) that post-operative neurapraxia is responsible for the at least temporary disappearance of spontaneous and nocturnal erections, leading to cavernous hypoxia. This is followed by tissue changes (reduction in smooth and elastic muscle fibers in the corpora cavernosa, increase in collagen and endothelial dysfunction), which modify the hemodynamics of the carvernum body and ultimately lead to fibrosis of the erectile tissue.\n\nThese changes can become permanent despite subsequent nerve recovery, and are exacerbated by neoadjuvant radiotherapy. It is therefore important not to wait passively for erectile function to be restored, as lack of oxygenation to the corpora cavernosa can lead to permanent fibrosis and dysfunction.\n\nThis physiopathology is at the origin of the concept of erectile rehabilitation after prostatectomy, with the aim of maintain erections post-operatively and thus limiting fibrosis.\n\nThe benefits of erectile re-education after prostatectomy were first reported in 1997, with the early use of intracavernous injections of alprostadil. Following this study, various rehabilitation strategies have been recommended. Early treatment, i.e. within the first month, is recommended to promote cavernous oxygenation and prevent fibrosis.\n\nThe aims of rehabilitation are as follows :\n\n* limit fibrosis;\n* limit penis retraction and loss of height;\n* oxygenate the cavernum body;\n* preserve endothelial structure;\n* preserve smooth muscle cell structure.\n\nVarious types of rehabilitation have been proposed: oral PDE-5 inhibitors, intra-cavernosal injections, urethral suppositories or vaccum.\n\nPDE-5 inhibitors prevent the degradation of cyclic guanosine monophosphate, thus compensating for the reduction in nitric oxide and enabling a better erection.\n\nErectile rehabilitation using PDE-5 inhibitors could protect cavernous smooth muscle from irreversible pathophysiological changes. The basic concept is to administer a PDE-5 inhibitor at bedtime to facilitate nocturnal erections, which are thought to have a natural protective effect on the function of the cavernous bodies.\n\nPadma-Nathan et al. reported the prospective administration of sildenafil 50 and 100 mg vs. placebo, daily and at bedtime, in patients undergoing nerve-sparing radical prostatectomy. After 36 weeks, erectile function was significantly better in the sildenafil group, with 27% responders, vs. 4% in the placebo group.\n\nThe mechanisms involved in erectile dysfunction after proctectomy for rectal cancer are similar to those of radical prostatectomy for prostate cancer.\n\nThe efficacy of PDE-5 inhibitors in the treatment of erectile dysfunction after proctectomy has already been demonstrated. However, its use as a preventive measure has rarely been reported.\n\nThree studies have evaluated PDE-5 inhibitors in patients with erectile dysfunction after rectal resection, two of which used sildenafil (Viagra, Pfizer, New York, NY)\n\nTo our knowledge, only one study has evaluated the role of PDE-5 inhibitors (PDE-5i) in a preventive strategy.\n\nOriginality and innovation Despite the fact that sexual dysfunction is recognized as a frequent complication of rectal cancer treatment, there are currently no recommendations for its prevention and management.\n\nIn contrast to prostate cancer patients, information and treatment concerning erectile dysfunction (ED) are not systematically offered to men with colorectal cancer. The ability of sildenafil to facilitate the return of erections after radical prostatectomy has been demonstrated in several studies, and this treatment could benefit patients treated for rectal cancer.\n\nTo date, no randomized study has examined the usefulness of this early rehabilitation in patients managed for rectal cancer. This study proposes, for the first time, to evaluate the use of sildenafil after neo-adjuvant radiotherapy and surgery for rectal cancer.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men aged 18 to 70\n* Patients undergoing surgery for cancer of the lower or middle rectum by total removal of the mesorectum with colorectal or coloanal anastomosis after neoadjuvant radiotherapy, with normal preoperative erectile function (defined by a combined IIEF erectile function domain score of at least 22).\n* Nerve-conserving surgery\n* Sexually active patient without treatment for erectile function prior to surgery\n* Presence of a regular sexual partner (male or female)\n* Adult having read and understood the information letter and signed the consent form\n* Membership of a social security scheme\n\nExclusion Criteria:\n\n* T4 tumor or tumor requiring extended surgery\n* Patients with abnormal erectile function defined by a combined IIEF erectile function domain score of less than 22.\n* History of prostate cancer\n* Sleep disorders, patients taking sedatives/hypnotics\n* Contraindication to SILDENAFIL EG 50 mg, film-coated tablet\n* Contraindication to placebo\n* Patients already treated with PDE5 inhibitors\n* Patients suffering from SARS COV 2\\*\n* Person deprived of liberty by an administrative or judicial decision or person placed under court protection / sub-guardianship or guardianship.\n* Any history of illness or psychological or sensory abnormality likely to prevent the subject from fully understanding the conditions required for participation in the protocol, or to prevent the subject from giving informed consent.\n* Person participating in another drug trial.'}, 'identificationModule': {'nctId': 'NCT06123156', 'acronym': 'RECTIL', 'briefTitle': 'Interest of Early Erectile Rehabilitation With Sildenafil After Radiotherapy and Proctectomy for Rectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Rouen'}, 'officialTitle': 'Intérêt de la rééducation érectile précoce Par Sildénafil après radiothérapie et Proctectomie Pour Cancer du Rectum : Essai contrôlé randomisé', 'orgStudyIdInfo': {'id': '2019/0398/HP'}, 'secondaryIdInfos': [{'id': '2020-002682-34', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Arm I (Sildénafil)', 'description': 'Sildénafil during 10 months (50mg daily), start 30 days after surgery', 'interventionNames': ['Drug: Sildenafil']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Arm II (Placebo)', 'description': 'Patients receive placebo during 10 month (1 platelet per day)', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Sildenafil', 'type': 'DRUG', 'otherNames': ['Arm I'], 'description': 'Sildénafil during 10 months (50mg daily), start 30 days after surgery', 'armGroupLabels': ['Arm I (Sildénafil)']}, {'name': 'Placebo', 'type': 'OTHER', 'otherNames': ['Arm II'], 'description': '1 platelet during 10 months (daily), start 30 days after surgery', 'armGroupLabels': ['Arm II (Placebo)']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Valérie Bridoux', 'role': 'CONTACT', 'email': 'valerie.bridoux@chu-rouen.fr', 'phone': '0232881347', 'phoneExt': '+33'}, {'name': 'Julie Rondeaux, PhD', 'role': 'CONTACT', 'email': 'julie.rondeaux@chu-rouen.fr', 'phone': '0232885427', 'phoneExt': '+33'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Rouen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}